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Journal articles on the topic 'FDCs (Fixed Dose Combinations)'

Author: Grafiati

Published: 4 June 2025

Last updated: 15 July 2025

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1

Supreet, Kamni, A. Naikwadi Akram, and Khot Anant. "An Evaluation of Fixed Dose Combinations (FDCs) Used for Treatment of Diabetes in Indian Market." International Journal of Current Research in Physiology and Pharmaocology 2, no. 1 (2018): 6–9. https://doi.org/10.5281/zenodo.2530830.

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Objective: To analyse the rationality of various FDCs used in the treatment Diabetes Mellitus and to find out the irrational FDCs existing in Indian market. Material and Methods: - Study Design: Analytical study. Data on FDC’s available in the Indian market was collected from Current Index of Medical Specialities (CIMS) and Monthly Index of Medical Specialities (MIMS) and their rationality was analysed using a pretested tool based on FDCs listed in WHO essential list of medicines and National List of Essential Medicines (NLEM), others based on their pharmacodynamic activity, Ph

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Gupta, Rohini, Apoorva Malhotra, and Pavan Malhotra. "Assessment of rational use of fixed dose combinations in hypertension in a tertiary care teaching hospital in north India." International Journal of Advances in Medicine 5, no. 5 (2018): 1263. http://dx.doi.org/10.18203/2349-3933.ijam20183905.

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Background: Fixed-dose combination (FDC) agents could be considered as an effective therapy in chronic illnesses like hypertension, which have multifactorial etiology. At present, many FDCs have come into the market without being assessed for their efficacy, safety and rationality by the drug regulatory authorities. The objective of the present study was to assess the rational use of fixed dose drug combinations in hypertension.Methods: It was a cross-sectional observational study conducted in the cardiology outpatient department of ASCOMS and H, Sidhra, Jammu, Jammu and Kashmir from February

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Aprajita, Rastogi, and Ramesh K. Goyal Prof. "Ban of Fixed Dose Combination on India Impact and Implications." International Journal of Trend in Scientific Research and Development 3, no. 5 (2019): 352–56. https://doi.org/10.5281/zenodo.3589769.

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Fixed dose combinations FDCs of drugs are important for public health perspective and commonly used for the treatment of pain and inflammation, hypertension, diabetes, malaria, tuberculosis, HIV AIDs etc. These ailments are considered to be the foremost threats to health in the world today. FDCs have proved to be advantageous as they are safe and effective. They increase efficiency, reduce the incidence of adverse drug effects, and improve patient compliance. The FDCs offer low cost as compared to individual components of active ingredients. On other hand if administered in unprofessional way,

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SS, Gill. "Guidelines on Fixed Dosage Combinations (FDCs): A Review." Bioequivalence & Bioavailability International Journal 7, no. 1 (2023): 1–4. http://dx.doi.org/10.23880/beba-16000197.

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Combination products, also known as fixed dose drug combinations (FDCs), are a combination of two or more active pharmacological components. In the US, the Food and Drug Administration defines a "product" as "any combination of a drug and a tool or a biological product." Regulatory Bodies, such as CDSCO, have laid down various rules and regulations on FDCs and classify them into four different types based on their origin status and have laid down requirements for FDCs under schedule Y and New Clinical Trials Rules 2019 along with rules such as rule 80.

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Jadhav, Sujata Abhay, Shaunak A. Pisal, Chitra C. Khanwelkar, Vandana M. Thorat, and Somnath M. Matule. "STUDY OF FIXED DOSE COMBINATIONS IN A TERTIARY CARE HOSPITAL." Asian Journal of Pharmaceutical and Clinical Research 9, no. 9 (2016): 35. http://dx.doi.org/10.22159/ajpcr.2016.v9s3.12615.

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ABSTRACTObjective: To study and analyze the pattern of fixed dose combinations (FDCs) in medicine outpatient clinic.Methods: The study is prospective cross-sectional study was conducted for 2 months in medicine outpatient clinic in tertiary care hospital. Aftertaking approval from Institutional Ethics Committee, the data were collected on every working day of the hospital. Prescriptions from the patientscoming to medicine outpatient clinic outpatient department were taken and required information is filled in data record form.Results: A total of 83 prescriptions were included in the study. Out

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Chukwunonso, C. Onwuzuligbo, and U. Onwuzuligbo Amarachukwu. "Fixed dose combination, a model therapy optimization strategy: A review." GSC Advanced Research and Reviews 20, no. 2 (2024): 036–46. https://doi.org/10.5281/zenodo.14948638.

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Therapy optimization involves a continuous improvement process of treatment interventions in the management of specific health challenges. Such optimization practices will not only help in achieving the desired treatment goals but will also improve the overall patients’ quality of life. One of the available therapy optimization strategy is the use of fixed dose combinations over monotherapies or poly-pharmacy. Fixed dose combination (FDC) is combination product that includes two or more active pharmaceutical ingredients (APIs) with similar or different pharmacological activity and differ

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Chukwunonso C Onwuzuligbo and Amarachukwu U Onwuzuligbo. "Fixed dose combination, a model therapy optimization strategy: A review." GSC Advanced Research and Reviews 20, no. 2 (2024): 036–46. http://dx.doi.org/10.30574/gscarr.2024.20.2.0296.

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Therapy optimization involves a continuous improvement process of treatment interventions in the management of specific health challenges. Such optimization practices will not only help in achieving the desired treatment goals but will also improve the overall patients’ quality of life. One of the available therapy optimization strategy is the use of fixed dose combinations over monotherapies or poly-pharmacy. Fixed dose combination (FDC) is combination product that includes two or more active pharmaceutical ingredients (APIs) with similar or different pharmacological activity and different me

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Chaudhry, Sunil. "Fixed dose combinations in India- what a way to go!" Indian Journal of Pharmacy and Pharmacology 10, no. 1 (2023): 45–49. http://dx.doi.org/10.18231/j.ijpp.2023.012.

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Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced

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Garg, Ram Ishwar, Gladson David Masih, and Bikash Medhi. "Nanoformulation and Fixed Dose Combination." International Journal of Pharmaceutical Sciences and Nanotechnology(IJPSN) 18, no. 2 (2025): 7897–901. https://doi.org/10.37285/ijpsn.2024.18.2.1.

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Nanoformulation refers to the design of drug delivery systems at the nanoscale to enhance solubility, stability, and bioavailability. According to the U.S. Food and Drug Administration (FDA), nanoformulation refers to the design and development of drug delivery systems with components in the nanoscale range (typically 1-100 nanometers), where the unique physiochemical properties at this scale are leveraged to enhance therapeutic efficacy, improve bioavailability, and enable targeted delivery1. FDC (Fixed-Dose Combination) combines two or more drugs in a single dosage form. As defined by the Ce

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Ravichandran, Aravind, Jayapriya Balamurugan, Shankareshwari, and Ramalingam Sekar. "Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital." International Journal of Basic & Clinical Pharmacology 6, no. 8 (2017): 1937. http://dx.doi.org/10.18203/2319-2003.ijbcp20173274.

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Background: Fixed dose combination (FDC) are currently most prescribed and misused drug forms. Although fixed dose combinations are clinically better than single dosage forms, improper prescription and large amounts of irrational FDC flooding leads to unwanted financial burden and increased resistance. Therefore a study was carried out to know about the existing scenario about Knowledge Attitude and Practice of Fixed dose combinations among the resident doctors and devise some suggestions for improving the rationality. The objective of the study was to evaluate the knowledge, attitude and pres

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Srivastava, Rohan, and N. D. Kantharia. "Evaluation of rationality of fixed dose combinations of antimicrobials available in Indian market." International Journal of Basic & Clinical Pharmacology 11, no. 2 (2022): 128. http://dx.doi.org/10.18203/2319-2003.ijbcp20220411.

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Background: The antimicrobial resistance is alarming at present. One of the important factors for resistance is use of irrational fixed dose combinations. Thus, objective was to critically analyze the rationality of FDCs of antimicrobial agents currently available in India.Methods: The FDCs of AMAs enlisted in Indian Drug Review 2019 were analyzed by 8 point criteria tool. Analysis includes number of active pharmacological ingredients, approval by central drug standard control organization, listing in world health organization model list of essential medicines (2019) or Government of India nat

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Korde, Rupa Arun, Radhika M. S., Priya Gandigawad, Ravi Sori, and Amruth . "Comparative study about knowledge, attitude and practice study of fixed dose combination among junior residents and interns of a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 7, no. 9 (2018): 1728. http://dx.doi.org/10.18203/2319-2003.ijbcp20183479.

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Background: Fixed Dose Combinations (FDCs) are defined by the World Health Organization (WHO) as combination of two or more active ingredients in a fixed ratio of doses. According to the FDA, “two or more drugs may be combined in a single dose when each component makes a contribution to the claimed effects, and the dosage of each component (i.e., amount, frequency, and duration) is such that the combination is safe and effective for significant patient population requiring such concurrent therapy. However, certain disadvantages like incompatible pharmacokinetics, inflexible dose ratio, increas

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Anilasree, B. P., K. P. Anuroopa, S. Arun Jyothi, T. Basila, and Swathi Saji. "Rationality of Fixed Dose Combinations of Central Nervous System Drugs in a Tertiary Care Hospital." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 15–18. http://dx.doi.org/10.22270/jddt.v9i4-a.3387.

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Objectives: To analyze the rationality of central nervous system fixed dose combinations used in a tertiary care hospital. Methodology: The study was an hospital based observational study. The data was collected from an annual drug compendium entitled “Hospital Drug List”. Fixed dose combinations (FDCs) enlisted in central nervous system (CNS) sections were selected for the study purpose. The active pharmacological ingredients (APIs) in FDC was checked for approval by Drug Control General of India (DCGI), World Health Organization (WHO) and essential medicine (EML)/national essential medicine

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Siddiqui, Riyaz, Tanaji Shende, and Harshal Mahajan. "Evaluation of prescribing pattern of fixed-dose combinations in obstetrics and gynecology department of a tertiary care hospital of central India." National Journal of Physiology, Pharmacy and Pharmacology 14, no. 5 (2024): 1. http://dx.doi.org/10.5455/njppp.2023.13.08391202310102023.

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Background: Improved patient compliance and cost effectiveness are two benefits of fixed-dose combination drugs. Irrational fixed-dose combinations (FDCs) raise the most urgent issue since they put patients at needless risk for negative medication responses. Aims and Objectives: The present study was done with objective of analyzing prescribing pattern of FDCs in department of fixed-dose combination in department of obstetrics and gynecology in a tertiary care hospital of central India. Materials and Methods: This study, which was both prospective and observational, was conducted at the tertia

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Joshi, Nupuri, Anvita Falke, Sajin Saji, Arundhati Diwan, and Asawari Raut. "Evaluation of prescribing pattern and rationality of fixed dose combinations in patients of general medicine department." International Journal of Basic & Clinical Pharmacology 9, no. 1 (2019): 122. http://dx.doi.org/10.18203/2319-2003.ijbcp20195773.

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Background: Fixed dose combinations are widely used in India, they are either irrational or prescribed irrationally. Moreover, the government has recently banned over 300 fixed dose combinations (FDCs) because of a lack of therapeutic justification. This study was conducted to study the prescribing pattern of FDCs in a tertiary care teaching hospital and to highlight the rationality of FDCs, and adverse drug reactions (ADRs) associated with them.Methods: In the present prospective observational study, a total of 500 inpatients were evaluated for prescribing pattern, cost analysis, and adverse

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Vyas, Niyati Devangkumar, Alpa P. Gor, and Jalpa V. Suthar. "EVALUATION OF PRESCRIBING PATTERN OF FIXED DOSE COMBINATIONS OF ANTIHYPERTENSIVES AND ANTIDIABETIC AGENTS." Asian Journal of Pharmaceutical and Clinical Research 10, no. 9 (2017): 164. http://dx.doi.org/10.22159/ajpcr.2017.v10i9.18966.

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Objective: The objective of this research was to evaluate prescribing pattern of fixed dose combinations (FDCs) of antihypertensives and antidiabetic agents among patients of private hospitals.Methods: An observational study was carried out in the outpatient department of two hospitals. Data of patients being diagnosed with the symptoms of hypertension and diabetes were enrolled which mainly included information related to prescribe FDCs, i.e., antihypertensives and antidiabetics, respectively. Descriptive analysis of collected information was done which involved representation of demographica

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Sankdia, Rajanish Kumar, and Mehul Agrawal. "Prescribing trends of fixed dose combinations in a tertiary care teaching hospital of Bhopal district." International Journal of Basic & Clinical Pharmacology 8, no. 3 (2019): 507. http://dx.doi.org/10.18203/2319-2003.ijbcp20190656.

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Background: Medicines are an integral part of healthcare. More than one drug is frequently used for treatment of either single ailment or multiple co-morbid conditions. Sometimes, two or more drugs are combined in a fixed ratio into a single dosage form, which is termed as fixed dose combinations (FDCs).Methods: This prospective observational study was carried out in the patients admitted in various medical and surgical wards of Chirayu hospital associated with Chirayu medical college of Bhopal district for a period of 3 months. The prescribed FDCs were collected from the case sheet of the adm

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R., Velvizhy, and Johan Pandian J. "Prescribing pattern of fixed dose combinations of antibiotics in a post-operative surgical ward of tertiary care teaching hospital." International Journal of Basic & Clinical Pharmacology 7, no. 12 (2018): 2332. http://dx.doi.org/10.18203/2319-2003.ijbcp20184841.

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Background: Fixed dose drug combinations (FDCs), are combinations of two or more active drugs. It should be used when the combination has an established advantage over single drug in efficacy, safety and compliance. The World Health Organization (WHO) lists only 19 of such combinations. But Indian market is filled with hundreds of FDCs which were not approved leading to irrational use. This study was focused on finding out the fixed dose combination of antimicrobial agents used in the post-operative general surgery ward of a tertiary care teaching hospital.Methods: After getting approval from

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Moriarty, Frank, Kathleen Bennett, and Tom Fahey. "Fixed-dose combination antihypertensives and risk of medication errors." Heart 105, no. 3 (2018): 204–9. http://dx.doi.org/10.1136/heartjnl-2018-313492.

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ObjectiveWhile fixed-dose combinations (FDC) can improve adherence, they may add complexity to the prescribing/dispensing process, potentially increasing risk of medication errors. This study aimed to determine if prescriptions for antihypertensive FDCs increase the risk of therapeutic duplication and drug–drug interactions (DDI).MethodsThis retrospective observational study used administrative pharmacy claims data from the Irish Primary Care Reimbursement Service. Prescriptions dispensed to adults in 2015 were included if they contained an antihypertensive FDC, or the same drugs prescribed se

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Baronova, O. D., V. A. Aksenova, N. I. Klevno, and S. V. Smerdin. "Experience of Fixed-Dose Combinations of Anti-Tuberculosis Drugs for Preventive Treatment in Children." Tuberculosis and Lung Diseases 101, no. 6 (2023): 66–72. http://dx.doi.org/10.58838/2075-1230-2023-101-6-66-72.

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The objective: to evaluate the effectiveness and safety of preventive treatment with fixed-dose combination of anti-tuberculosis drugs (FDCs) in children from groups at high risk of developing tuberculosis.Subjects and Methods. Effectiveness of preventive treatment was analyzed in 318 children from groups at high risk of developing tuberculosis. Also, we studied the possibility of successful completion of the full course of treatment using FDCs and preventive treatment regimens containing at least two single drugs. Inclusion criteria were as follows: the child at high risk of developing tuberc

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Inotai, András, Zoltán Kaló, Zsuzsanna Petykó, et al. "Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases." Journal of Cardiovascular Development and Disease 11, no. 7 (2024): 186. http://dx.doi.org/10.3390/jcdd11070186.

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Despite the availability of affordable pharmaceuticals treating cardiovascular diseases (CVDs), many of the risk factors remain poorly controlled. Fixed-dose combinations (FDCs), a form of incremental innovation, have already demonstrated improvements over combinations of single medicines in adherence and hard clinical endpoints. Nevertheless, there are many barriers related to the wider use of FDCs in CVDs. Our aim was to identify these barriers and explore system-level facilitators from a multi-stakeholder perspective. Identified barriers include (i) hurdles in evidence generation for manufa

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C. H., Manjunatha, Rohith V., Maheshwari R., and Isabella Topno. "Prescription Pattern of fixed dose drug combinations in obstetrics and gynecology department of a tertiary care hospital in Puducherry, India: an observational study." International Journal of Basic & Clinical Pharmacology 7, no. 11 (2018): 2122. http://dx.doi.org/10.18203/2319-2003.ijbcp20184311.

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Background: Fixed drug combinations (FDCs)have various advantages and disadvantages. In countries like India there are numerous irrational prescriptions as highlighted by the recent banning of FDCs in October 2018. Studying the prescription pattern helps in developing national database which can be used to promote rational use of drugs.Methods: All the Outdoor Patient Department (OPD) prescriptions from department of Obstetrics and Gynecology (OBG) during the study period were used for the study. The drugs were classified according to Anatomical Therapeutic Chemical (ATC) classification. Other

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Kumar, Gaurav, Kishore Navin, and Singh Asha. "Cutaneous Adverse Drug Reactions with Fixed-Dose Combinations: Special Reference to Self-medication and Preventability." International Journal of Pharmaceutical and Clinical Research 15, no. 9 (2023): 1527–30. https://doi.org/10.5281/zenodo.11390664.

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<strong>Introduction: </strong>A cutaneous adverse drug reaction (CADR) is any unfavourable cutaneous clinical manifestation that happens after taking a certain medicine. ADRs are more likely to occur when fixed dose drug combinations (FDCs) are used than when a drug is taken alone. <strong>Method: </strong>In Department of Pharmacology, Nalanda Medical College, Patna, a prospective, spontaneous ADR reporting research was carried out over a period of one year. ADRs that were reported after suspected FDC usage were assessed for severity (modified Hartwig scale), causality (WHO-UM

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Janczura, Magdalena, Małgorzata Kobus-Moryson, Szymon Sip, Marcin Żarowski, Agnieszka Wareńczak, and Judyta Cielecka-Piontek. "Fixed-Dose Combination of NSAIDs and Spasmolytic Agents in the Treatment of Different Types of Pain—A Practical Review." Journal of Clinical Medicine 10, no. 14 (2021): 3118. http://dx.doi.org/10.3390/jcm10143118.

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This review presents the most common disease entities in which combinations of NSAIDs and spasmolytic drugs are used to reduce pain. The benefits of fixed-dose combination products (FDCs) are that they improve the response in people with insufficient monotherapy. Using the synergy or additive effect of drugs, it is possible to obtain a significant therapeutic effect and faster action with the use of smaller doses of individual drugs. In addition, one active ingredient may counteract adverse reactions from the other. Another essential aspect of the use of FDCs is the improvement of medical adhe

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Levchenkova, O. S., R. R. Galimulina, B. R. Komev, and K. D. Zagnet. "Choice Between Free Combination of Antihypertensive Agents and Fixed Dosed Combinations in the Treatment of Arterial Hypertension." Russian Archives of Internal Medicine 14, no. 5 (2024): 325–38. http://dx.doi.org/10.20514/2226-6704-2024-14-5-325-338.

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Most patients with arterial hypertension require more than one antihypertensive drug for blood pressure target achievement. Some patients are recommended for a multi-pill antihypertensive regimen, others — treatment with fixed dosed combinations in one tablet. Analysis of elibrary and PubMed publications in the period mostly from 2014 to 2024 concerning the choice of two-component combined antihypertensive agents containing renin-angiotensin system inhibitor and diuretic or calcium channel blocker, revealed that fixed-dose combinations (FDC) use and taking one tablet once a day improves adhere

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Rajitha, Maddala, Altaf Hussain Shaik, G. B. Simpson, and A. Vishwa Shanthi. "Study on rationality of different fixed dose drug combinations in tertiary care hospital: an evaluation study." International Journal of Basic & Clinical Pharmacology 9, no. 3 (2020): 422. http://dx.doi.org/10.18203/2319-2003.ijbcp20200714.

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Background: The fixed dose drug combinations (FDCs) of drugs is defined as product of two or more active ingredients in a defined composition. There is a need to study the pattern of prescription from time to time to evaluate their rationality. In this context we undertook this study to know the prescription pattern of FDC in our setting. To study the rationality of different prescribed FDCs.Methods: This is a prospective study which is carried out in NIMRA Institute of medical sciences which is a tertiary care teaching private hospital. For this study we have collected one thousand prescripti

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Shrestha, Rajeev, and Sushmita Gurung. "An evaluation of fixed dose combinations and it’s practices at medicine department of tertiary care hospital, Nepal." International Journal of Scientific Reports 6, no. 2 (2020): 67. http://dx.doi.org/10.18203/issn.2454-2156.intjscirep20200197.

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<p class="abstract"><strong>Background:</strong> A large proportion of fixed dose combinations (FDCs) are manufactured and used widely in Nepal. This study aimed to evaluate the FDCs and its utilization in medicine department of tertiary care hospital.</p><p class="abstract"><strong>Methods:</strong> A cross-sectional study was conducted for 50 days among admitted patients in the medicine department of tertiary care hospital, Nepal. A predesigned form was used to collect the data at the time of patient discharge. Only the oral FDCs were selected for st

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P, Pavazhaviji, and Rajalakshmi A. N. "FIXED-DOSE COMBINATION DRUGS AS TABLET IN TABLET: A REVIEW." International journal of multidisciplinary advanced scientific research and innovation 1, no. 9 (2021): 169–77. http://dx.doi.org/10.53633/ijmasri.2021.1.9.02.

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The Pharmaceutical industry has become more interested in developing fixed-dose combinations (FDCs) in recent years. FDCs have been used successfully in a variety of clinical areas, including diabetes, HIV/AIDS,and cardiovascular diseases etc. FDCs are intended to extend the product life cycle and enhance patient compliance by decreasing cost. Active Pharmaceutical ingredients are chosen for FDC development based on variety of purposes such as Pharmacokinetic profile, drug-drug interactions, mechanism of action, and manufacturability for successful development. Tablet in tablet technology has

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Mahato, Tapan Kumar. "An effort to comprehend the rationales behind the prohibition of fixed dose combinations." Journal of Pharmaceutical advanced research 6, no. 11 (2023): 1937–42. https://doi.org/10.5281/zenodo.10447867.

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ABSTRACT: Pharmaceuticals encompass compounds utilized for the purposes of disease treatment, alleviation, diagnosis, and prevention. The substances in question can be classified into three categories: synthetic, semi-synthetic, or natural. A condition can be treated either by a single treatment or by the separate administration of numerous drugs. Another approach involves the use of specific dosage forms that contain two or more pharmaceuticals, known as fixed dose combinations. The term "fixed dose combination" refers to the incorporation of many active componen

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Mbuthia, Daniel, Ruth Willis, Mary Gichagua, Jacinta Nzinga, Peter Mugo, and Adrianna Murphy. "Acceptability of fixed-dose combination treatments for hypertension in Kenya: A qualitative study using the Theoretical Framework of Acceptability." PLOS Global Public Health 5, no. 3 (2025): e0003012. https://doi.org/10.1371/journal.pgph.0003012.

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Fixed-dose combinations (FDCs) – 2-3 anti-hypertensive medications in a single pill - have the potential to improve hypertension treatment and outcomes. Yet, they are not widely implemented. Factors undermining implementation remain unknown, particularly in sub–Saharan Africa, where hypertension is a major cause of disease burden and is poorly controlled. This study explored the acceptability of FDCs among patients, caregivers, and healthcare workers. We conducted semi-structured in-depth interviews with 58 participants from four purposively selected health facilities in Kiambu county, Kenya.

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Acharya, Monika, and Gaurav Dubey. "Advancements in Controlled Release Drug Delivery Systems for Fixed Dose Combinations: A Comprehensive Study." Journal of Neonatal Surgery 14, no. 4S (2025): 237–44. https://doi.org/10.52783/jns.v14.1778.

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Background: Controlled release drug delivery systems (CRDDS) and fixed-dose combinations (FDCs) have revolutionized pharmaceutical science, offering improved therapeutic outcomes and patient compliance. Integrating CRDDS into FDCs enables optimized drug release profiles, reduced dosing frequency, and enhanced medication synergy. Methods: This study evaluates key CRDDS techniques, including layered tablets, multiparticulate systems, matrix systems, and osmotic systems, focusing on their formulation, analytical approaches, and performance. Preformulation studies, coating techniques, dissolution

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Tapan, Kumar Mahato. "An effort to comprehend the rationales behind the prohibition of fixed dose combinations." Journal of Pharmaceutical advanced research 6, no. 11 (2023): 1964–69. https://doi.org/10.5281/zenodo.10576749.

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<strong>ABSTRACT:</strong> Pharmaceuticals encompass compounds utilized for the purposes of disease treatment, alleviation, diagnosis, and prevention. The substances in question can be classified into three categories: synthetic, semi-synthetic, or natural. A condition can be treated either by a single treatment or by the separate administration of numerous drugs. Another approach involves the use of specific dosage forms that contain two or more pharmaceuticals, known as fixed dose combinations. The term "fixed dose combination" refers to the incorporation of many act

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Mir, Shakeel Ahmad. "A survey to assess awareness about fixed dose combinations (FDCs) among pharmacists in two Central Kashmir Districts, Srinagar and Budgam, Kashmir, India." International Journal of Basic & Clinical Pharmacology 6, no. 5 (2017): 1133. http://dx.doi.org/10.18203/2319-2003.ijbcp20171664.

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Background: FDCs are highly popular in Indian pharmaceutical market. The FDCs have both advantages as well as disadvantages. To be advantageous WHO guidelines for the manufacture and use of FDCs must be strictly followed. Irrational use of FDCs is a major public health problem and leads to increased risk of adverse drug events, higher treatment costs and antimicrobial resistance. FDCs as well as other single component drugs cannot be used rationally unless everyone involved directly or indirectly in the health care profession is involved. Pharmacist is a coordinator between different members o

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Evans, Valerie, Peter Roderick, and Allyson M. Pollock. "Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India." BMJ Global Health 3, no. 2 (2018): e000263. http://dx.doi.org/10.1136/bmjgh-2016-000263.

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There is growing national and international concern about the drug regulatory system in India. Parliamentary reports have highlighted the presence of high numbers of unapproved medicines and irrational combinations of both approved and unapproved drugs in the Indian market-place. Fixed-dose combinations (FDCs) are a peculiar feature of the Indian pharmaceutical landscape. Although metformin is a first-line treatment, FDCs for diabetes in India account for two-thirds of all diabetes medicine sales, and some have not been approved by the Central Drugs Standard Control Organization (CDSCO). This

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Mitkovska, Marija, Katerina Anchevska Netkovska, Aleksandra Grozdanova, Ana Poceva Panovska, and Ema Kikovska Stojanovska. "Importance of patents and data exclusivity in fixed-dose combination medicinal products." Macedonian Pharmaceutical Bulletin 65, no. 2 (2019): 33–38. http://dx.doi.org/10.33320/maced.pharm.bull.2019.65.02.004.

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The efficacy of an active compound can be advantageously improved when combined with other active compounds. Medicinal products for a particular indication(s) that contain combination of two or more active compounds in a fixed dose ratio is so called fixed-dose combination medicinal products or FDCs. FDCs are beneficial for patients’ adherence to the treatment because of the simplified drug regimen. They are used in the treatment of a wide range of medical conditions especially in the treatment of chronic illnesses including AIDS, type 2 diabetes, and many cardiovascular diseases. FDCs as othe

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Ranjalkar, Jaya, Ratinder Jhaj, Sujith J Chandy, et al. "Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers." Journal of The Association of Physicians of India 71, no. 2 (2023): 30–36. http://dx.doi.org/10.5005/japi-11001-0175.

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Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classifi

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Mandal, Ananya, Sonai Mandal, and Somenath Das. "Knowledge, attitude and practice regarding use of fixed dose combination drugs among young prescribers a tertiary care teaching hospital in rural Bengal, India." International Journal of Basic & Clinical Pharmacology 8, no. 7 (2019): 1479. http://dx.doi.org/10.18203/2319-2003.ijbcp20192601.

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Background: Use of fixed dose combination (FDCs) is a double edged sword with scope for irrational prescribing on one hand and improved pharmacotherapy and patient compliance on the other hand. Irrational FDCs are being marketed aggressively and often young prescribers including Post Graduate Trainees fall prey to the lure of FDCs. This was a Knowledge-Attitude-Practice study regarding of FDC use among the resident doctors working at a tertiary care medical college of rural Bengal.Methods: This was a cross-sectional, questionnaire based study including 50 resident doctors who were asked to fil

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Bortone, Barbara, Charlotte Jackson, Yingfen Hsia, Julia Bielicki, Nicola Magrini, and Mike Sharland. "High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75 countries." PLOS ONE 16, no. 1 (2021): e0241899. http://dx.doi.org/10.1371/journal.pone.0241899.

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Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antib

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Gautam, Chandler S., and Lekha Saha. "Fixed dose drug combinations (FDCs): rational or irrational: a view point." British Journal of Clinical Pharmacology 65, no. 5 (2008): 795–96. http://dx.doi.org/10.1111/j.1365-2125.2007.03089.x.

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Huang, Wei-Chun, Chih-Yu Chen, Wei-Chih Liao, et al. "Differences in Pulmonary Function Improvement after Once-Daily LABA/LAMA Fixed-Dose Combinations in Patients with COPD." Journal of Clinical Medicine 11, no. 23 (2022): 7165. http://dx.doi.org/10.3390/jcm11237165.

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This real-world study evaluated the efficacy of once-daily long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) for improving lung function in patients with chronic obstructive pulmonary disease (COPD). Patients with COPD who were treated with once-daily LABA/LAMA FDCs for 12 months were included. We evaluated their lung function improvement after 12 months of treatment with different LABA/LAMA FDCs. A total of 198 patients with COPD who were treated with once-daily LABA/LAMA FDCs were analyzed. A total of 114 patients were treated with umeclidi

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., Roshi, and Vishal R. Tandon. "Adverse drug reactions due to fixed dose combinations: an observational cross sectional study." International Journal of Basic & Clinical Pharmacology 8, no. 11 (2019): 2412. http://dx.doi.org/10.18203/2319-2003.ijbcp20194776.

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Background: In modern world, poor compliance has been the main reason of therapeutic failure. Many factors may be responsible for this. The reasons highlighted may be adverse drug reactions (ADRs), pill burden or economic reasons. Fixed drug combinations (FDC) have helped to solve this problem. The present study was conducted to see the ADR due to fixed dose combinations.Methods: After approval from institutional ethics committee, an observational study was conducted over a period of six months in December 2018 to May 2019 in adverse drug monitoring centre, GMC Jammu.Results: A total number of

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Vurimi Chaitanya Sai Manikanta. "An Evaluation for Diabetic patient by measuring FDCs." International Journal of Pharmacometrics and Integrated Biosciences 5, no. 2 (2020): 22–25. http://dx.doi.org/10.26452/ijpib.v5i2.1271.

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Type 2 diabetes mellitus (T2DM) is an enlightened diseases with multifactorial etiology. The first-line therapy includes monotherapy, which often fails to achieve effective glycemic control, necessitating the addition of add-on therapy. In this regard, multiple single-dose combinations called fixed-dose combinations (FDCs) have been evaluated for their safety, efficacy, and tolerability. To analyze the rationality of diverse FDCs used in the remedy Diabetes Mellitus and to find out the irrational FDCs existing in Indian market. A overall of 18 mixtures had been analyzed, amongst the ones 11 co

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Rogliani, Paola, Josuel Ora, Francesco Cavalli, Mario Cazzola, and Luigino Calzetta. "Comparing the Efficacy and Safety Profile of Triple Fixed-Dose Combinations in COPD: A Meta-Analysis and IBiS Score." Journal of Clinical Medicine 11, no. 15 (2022): 4491. http://dx.doi.org/10.3390/jcm11154491.

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Background: Triple fixed-dose combination (FDC) therapy is recommended in severe chronic obstructive pulmonary disease (COPD) patients experiencing frequent exacerbations and/or symptoms not controlled by dual FDCs. Since no randomized controlled trials (RCTs) have directly compared the different inhaled corticosteroid/long-acting β2-adrenoceptor agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) FDCs, we performed a meta-analysis to compare the impact of the current available ICS/LABA/LAMA FDCs in COPD. Methods: A meta-analysis was performed by connecting beclomethasone dipropionate/fo

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Sathish Kumar B., Rohan A., and Naveen Gowda B. "Analysis of fixed dose combinations of expectorants, antitussives, decongestants, antihistamines and mucolytics available in the Indian market for rationality and cost variation." International Journal of Basic & Clinical Pharmacology 12, no. 3 (2023): 422–26. http://dx.doi.org/10.18203/2319-2003.ijbcp20231122.

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Background: Aim of the current study was to analyze the FDCs of expectorants, antitussives, decongestants, antihistamines and mucolytics available in the Indian market for their rationality, cost, and dosage forms. Methods: FDCs involving expectorants, antitussives, decongestants, antihistamines and mucolytics listed on Drug Today and Jan Aushadhi online portal were analysed for rationality according to the list of banned FDCs by CDSCO published on 01 Jan 2018. The FDCs with EADAM available in Jan Aushadhi online portal are compared with cost of different brands with same composition, strength

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Geetha, Abinish Dyneese, Dhanalakshmi Ramasamy, Yusuf Siddiq Jamal Ahamed, et al. "Analysis of fixed dose combinations and price variations of oral antidiabetic agents in the Indian pharmaceutical market." Indian Journal of Pharmacy and Pharmacology 11, no. 4 (2024): 213–20. https://doi.org/10.18231/j.ijpp.2024.035.

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The objective of this study was to analyse the price variations of Fixed Dose Combinations (FDCs) of oral antidiabetic agents in India to highlight the percentage price variations among different brands offering the same formulations of oral antidiabetic FDCs.Diabetes is a metabolic disorder requiring consistent medication for blood glucose control. The wide cost variation among antidiabetic agents affects patient access and adherence, underscoring the importance of evaluating price differences to support affordable, effective diabetes management.This analytical study was conducted from August

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Kanchan, Kumari, Kumari Asha, and Kumar Naveen. "A Study to Assess the Prescription Pattern to Promote Rational Use of Drugs: Cross-Sectional Descriptive Study." International Journal of Current Pharmaceutical Review and Research 16, no. 01 (2024): 296–99. https://doi.org/10.5281/zenodo.11543060.

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AbstractAim: The aim of the present study was to assess the prescription pattern to promote rational use of drugs.Methods: A cross-sectional descriptive study was done for one year in DMCH in Darbhanga. Prescriptions fromOut-patient departments especially Medicine and Pediatrics were collected and analyzed. The prescribed fixeddose combination drugs and other drugs were categorized according to Anatomical Therapeutic Chemicalclassification (ATC classification).Results: Most common FDCs in elderly age group belonged to Gastrointestinal system and in Pediatric populationmainly respiratory system

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Adonkina, Viktoriya, and Oksana Mishchenko. "Pharmacoeconomic evaluation of fixed-dose triple combination for antihypertensive therapy in Ukraine." Journal of Health Policy & Outcomes Research, no. 1 (August 14, 2014): 66–75. http://dx.doi.org/10.7365/jhpor.2014.5.8.

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In Ukraine, the efficacy of treatment of arterial hypertension is only 19% in urban areas and 8 % in rural populations. The most important reasons of low efficiency of antihypertensive therapy (AHT) are a wrong choice of tactics of the patient management and low adherence of patients to treatment. The latter decreases with increasing amounts of prescribed drugs. One possible way to increase patients’ compliance to treatment and the effectiveness of therapy is to use fixed-dose combinations (FDCs) of antihypertensive drugs (AHDs). The share of FDCs consumption (in terms of DDDs/1000/day) in Ukr

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Mahato, Tapan Kumar, Rajendra Singh Kushwaha, Saurabh Sharma, Zankhana Brahmbhatt, and Ankur Patel. "An Investigation into the Reasoning for the Ban on Fixed Dosage Combinations." International Journal of Multidisciplinary Research and Growth Evaluation 5, no. 5 (2024): 657–62. http://dx.doi.org/10.54660/.ijmrge.2024.5.5.657-662.

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Either a single treatment or the sequential administration of multiple medications can be used to treat an aberrant situation. Utilising fixed dose combinations—specific dosage forms including two or more medications is another strategy. A fixed dose combination is a pharmacological administration method that combines two or more active ingredients into one. Because of all the benefits these products offer, prescribers and consumers alike are quite interested in using them. There are unavoidable intrinsic disadvantages as well. Popular antibiotics, pain relievers, and multivitamins are among t

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Gong, Yiwen, Yinghua Lv, Hongxia Liu, Qingshan Zheng, and Lujin Li. "Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD." Therapeutic Advances in Respiratory Disease 16 (January 2022): 175346662110660. http://dx.doi.org/10.1177/17534666211066068.

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Objective: This study aimed to quantitatively compare the efficacy and safety of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) for the treatment of stable chronic obstructive pulmonary disease (COPD), especially in terms of their loss of efficacy in lung function. Methods: Randomized controlled clinical trials of LABA/LAMA FDCs for the treatment of stable COPD were comprehensively searched for in public databases. Pharmacodynamic models were established to describe the time course of the primary outcome [trough forced expiratory volume in

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Pyadushkina, Elena A., and Elena V. Derkach. "The analysis of the availability of fixed-dose combinations in antiretroviral therapy for HIV infection in the Russian Federation." Terapevticheskii arkhiv 93, no. 12 (2021): 1516–21. http://dx.doi.org/10.26442/00403660.2021.12.201296.

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Aim. To analyze the features of drugs provision for special groups of treatment-nave HIV-infected patients initiating antiretroviral treatment with fixed dose combination (FDC) for once-daily single-tablet regimen, in Russian healthcare setting. Materials and methods. We studied the regulatory legal documents governing the provision of antiretroviral drugs in Russia and analyzed the Russian Program of State Guarantees to determine the inclusion of the investigated FDCs in the lists of regional benefits, as well as regional and federal procurement of these drugs in 2020 and 2021. We compa

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