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Journal articles on the topic 'Bioequivalence'

Author: Grafiati

Published: 4 June 2021

Last updated: 25 July 2025

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1

Balthasar, Joseph P. "Bioequivalence and Bioequivalency Testing." American Journal of Pharmaceutical Education 63, no. 2 (1999): 194–98. http://dx.doi.org/10.1016/s0002-9459(24)01740-6.

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2

Micheal, Francis, Mohanlal Sayana, Rajendra Prasad, and Balamurali Musuvathi Motilal. "Has the Time Come to Employ Population and Individual Bioequivalence for the Evaluation of Generics?" Current Drug Metabolism 21, no. 2 (2020): 112–25. http://dx.doi.org/10.2174/1389200221666200401105119.

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Background: Bioequivalence studies are a vital part of drug development. The average bioequivalence approach is the standard method of assessment to conclude whether the generic product is bioequivalent to the innovator product. Of late, debates are on whether the average bioequivalence approach adequately addresses drug interchangeability as it considers only population mean for the evaluation especially when highly variable drug products and narrow therapeutic index drugs are dealt with. Hence, the alternative approaches like population bioequivalence and individual bioequivalence assessment

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Blier, Pierre. "Generic Substitution for Psychotropic Drugs." CNS Spectrums 14, no. 9 (2009): 1–7. http://dx.doi.org/10.1017/s1092852900024706.

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Most antidepressants and other psychotropics in clinical use are available as generic formulations (Table). The availability of lower-priced, generic drugs can benefit patients and third-party payers, but it should not be assumed that all generic drugs are equally beneficial. There are numerous reports in the literature of unexpected and untoward consequences that occur when a generic drug is substituted for the original brand-name drug. A previously stable clinical response may suddenly deteriorate, or the patient may experience new or more severe adverse events (AEs). The United States Food

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4

Ozdin, Deniz, Murray P. Ducharme, France Varin, Anders Fuglsang, and Dina Al-Numani. "Influence of Different Populations on Pharmacokinetic Bioequivalence Results: Can We Extrapolate Bioequivalence Results from One Population to Another?" Journal of Pharmacy & Pharmaceutical Sciences 23 (October 14, 2020): 357–88. http://dx.doi.org/10.18433/jpps30872.

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Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic bioequivalence studies for European/North American generic submissions appeared to have been conducted in geographical/ethnic populations other than those for which the drug is marketed for. The results of pharmacokinetic bioequivalence studies have traditionally been considered to be insensitive to the population studied. However, several recent studies have suggested that this may not necessarily be true. The objective of this study was to investigate whether there were any concerns regarding the current practi

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Khokhlov, A. L., A. A. Khokhlov, A. E. Miroshnikov, O. V. Lebedeva, and D. Yu Grebenkin. "Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl." Pharmacokinetics and Pharmacodynamics, no. 4 (January 19, 2023): 62–68. http://dx.doi.org/10.37489/2587-7836-2022-4-62-68.

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Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of Mikardis® (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) and Telzap® (telmisartan, tablets 80 mg, Zentiva KS company, Czech Republic) in healthy volunteers after a single ad

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Li, Jianghao, and Shein-Chung Chow. "Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability." Journal of Probability and Statistics 2015 (2015): 1–13. http://dx.doi.org/10.1155/2015/298647.

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For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study. A test product is said to be average bioequivalent to a reference (innovative) product if the 90% confidence interval of the ratio of means (after log-transformation) is totally within (80%, 125%). This approach is considered a one-parameter approach, which does not account for possible heterogeneity of variability between drug products. In this paper, we study a two-parameter approach (i.e., confidence

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Kubesh, V., A. L. Khokhlov, A. M. Shitova, et al. "Pharmacokinetic and Bioequivalence Study of Telzap AM® (Telmisartan/amlodipine Fixed-dose Combination) and Coadministered Mikardis® (Telmisartan) and Norvask® (Amlodipine) in Healthy Subjects." Drug development & registration 9, no. 4 (2020): 155–63. http://dx.doi.org/10.33380/2305-2066-2020-9-4-155-163.

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Introduction. A fixed dose combination of telmisartan and amlodipine is widely used in clinical practice during hypertension treatment. Combination of telmisartan and amlodipine demonstrates potentiating synergistic effect on blood pressure decrease. A bioequivalence study of Telzap® AM with coadministered Mikardis® and Norvask® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of the fixed dose combination drug product Telzap® AM (telmisartan + amlodipine, tablets, 80 + 10 mg, Zentiv

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Khokhlov, A. L., A. A. Khokhlov, A. E. Miroshnikov, O. V. Lebedeva, and D. Yu Grebenkin. "Pharmacokinetic and bioequivalence study of Telzap® Plus fixed-dose combination compared with MikardisPlus® in healthy volunteers after single administration." Pharmacokinetics and Pharmacodynamics, no. 4 (January 19, 2023): 69–77. http://dx.doi.org/10.37489/2587-7836-2022-4-69-77.

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Introduction. A fixed dose combination of telmisartan and hydrochlorothiazide is indicated for treatment of in the treatment of arterial hypertension. The combination of these substances causes an additive effect that helps to reduce blood pressure. A bioequivalence study of Telzap® Plus compared with MikardisPlus® was conducted with 63 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of the fixed dose combination drug product Telzap® Plus (tablets 80 mg + 12,5 mg, Zentiva KS company, Czech Republic) comp

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9

Hamrell, Michael R., Marilyn N. Martinez, Shrikant V. Dighe, and Paul D. Parkman. "Bioequivalence of Generic Thioridazine Drug Products—The FDA Viewpoint." Drug Intelligence & Clinical Pharmacy 21, no. 4 (1987): 362–69. http://dx.doi.org/10.1177/106002808702100413.

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The phenothiazines are among the most widely used drugs to treat symptoms commonly associated with acute and chronic psychoses. One of the commonly prescribed compounds within this class of drugs is thioridazine, available both as a generic product as well as the innovator product, Mellaril. Each of these products is coded as bioequivalent and consequently therapeutically equivalent by the Food and Drug Administration (FDA). A recent issue of this journal contained an article that raised a number of questions concerning the bioequivalence of the generic versions of thioridazine that have been

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Kim, Suyoung, HyunYoung Chae, Eon-Bee Lee, Gayeong Lee, Seung-Chun Park, and Jeongwoo Kang. "Comparative Pharmacokinetics and Bioequivalence of Pour-On Ivermectin Formulations in Korean Hanwoo Cattle." Antibiotics 13, no. 1 (2023): 3. http://dx.doi.org/10.3390/antibiotics13010003.

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This study aimed to conduct a bioequivalence study of applying three pour-on ivermectin formulations at a dose of 1 mg/kg on the back of Korean native beef cattle (Hanwoo). To conduct bioequivalence testing, the pharmacokinetics of three groups (control Innovator, test Generic A, and test Generic B) of five clinically healthy Korean Hanwoo cattle (average weight 500 kg) were studied. After topical application to the skin, blood samples were drawn at the indicated times. These blood samples were analyzed using liquid chromatography–tandem mass spectrometry (LC-MS/MS). The time required to reach

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Henriques, Sara Carolina, Ana Leblanc, Sérgio Simões, et al. "Unveiling the Potential of Cmax f2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products." Pharmaceutics 16, no. 12 (2024): 1579. https://doi.org/10.3390/pharmaceutics16121579.

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Background: When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy to decide whether to move forward or not with a full-size pivotal study. However, due to the small study size, these studies are inarguably more sensitive to variability. Objectives: To address and mitigate the uncertainty of the conclusions of pilot studies concerning the maximum observed concentration (Cmax), the f2 factor was proposed as an alternative approach to the average

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Ducray, François, Carole Ramirez, Marie Robert, et al. "A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules." Pharmaceutics 15, no. 12 (2023): 2664. http://dx.doi.org/10.3390/pharmaceutics15122664.

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Background: Temozolomide (TMZ) oral suspension (Ped-TMZ, KIZFIZO®) is being developed for the treatment of relapsed or refractory neuroblastoma, a rare cancer affecting infants and young children. The study assessed the safety and the bioequivalence of this novel pediatric formulation with existing TMZ oral capsules. Methods: In vitro dissolution profiles and the bioequivalence were evaluated following the European Medicines Agency “Guidelines on the investigation of Bioequivalence”. The phase I, multicenter, randomized, open-label, crossover, single-dose bioequivalence study enrolled 36 adult

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Harikrishnan, Nishalini, Ka-Liong Tan, Kar Ming Yee, Alia Shaari Ahmad Shukri, Nalla Ramana Reddy, and Chuei Wuei Leong. "Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers." Generics and Biosimilars Initiative Journal 10, no. 3 (2021): 113–18. http://dx.doi.org/10.5639/gabij.2021.1003.013.

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Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 mg tablet formulation. A dissolution study was conducted to optimize the formulation process before evaluating physical changes in the active pharmaceutical ingredient and the formulated product. Methods: This was a randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, two-way crossover, truncated bioequivalence study involving a washout period of ten days. A total of 26 healt

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Henriques, Sara Carolina, Paulo Paixão, Luis Almeida, and Nuno Elvas Silva. "Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method." Pharmaceutics 15, no. 10 (2023): 2498. http://dx.doi.org/10.3390/pharmaceutics15102498.

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Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally calculated. In a previous work, authors recommended the use of an alternative approach to the average bioequivalence methodology to evaluate pilot studies’ data, using the geometric mean (Gmean) ƒ2 factor with a cut off of 35, which has shown to be an appropriate method to assess the potential bioequivalence for the maximum observed concentration (Cmax

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15

Khokhlov, A. L., D. Yu Grebenkin, E. K. Faeva, et al. "Pharmacokinetic and Bioequivalence Study of the Two-component Drug Product "Ezetimibe + rosuvastatin" (JSC "Sanofi-aventis group", Russia): Resuts and Experience with the Use of Enzymatic Hydrolysis in the Analysis of Samples." Drug development & registration 12, no. 1 (2023): 142–53. http://dx.doi.org/10.33380/2305-2066-2023-12-1-142-153.

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Introduction. As a part of the registration of the drug product a bioequivalence study of the fixed-dose combination "Ezetimibe + rosuvastatin" (JSC "Sanofi-aventis group", Russia) compared with coadministered Ezetrol® (ezetimibe) and Crestor® (rosuvastatin) was conducted with 76 healthy volunteers. Enzymatic hydrolysis was used to evaluate the pharmacokinetics of total ezetimibe. This was the reason for the inclusion of the additional monitored parameters in the validation and analysis.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of

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Chougale, Nilesh. "Parameters to be Considered in A Bioequivalence Study of Drug." International Journal for Research in Applied Science and Engineering Technology 9, no. 8 (2021): 1693–701. http://dx.doi.org/10.22214/ijraset.2021.37638.

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Abstract: Bioequivalence is a word used to describe the biological equivalency of two proprietary medication preparations. When two medications are bioequivalent, it indicates they are expected to be the same. Pharmacokinetic studies are used to determine bioequivalence between two medications, such as a reference drug (FDA approved drug) and a potential test drug (marketed generic drug), by administering each drug to volunteers in a cross-over research (healthy individuals). To prepare a drug many aspects need to take into consideration such as in vivo and in vitro study, pharmacokinetics, ph

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Yamada, Mikiko, and Timothy E. Welty. "Generic Substitution of Antiepileptic Drugs: A Systematic Review of Prospective and Retrospective Studies." Annals of Pharmacotherapy 45, no. 11 (2011): 1406–15. http://dx.doi.org/10.1345/aph.1q349.

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Objective: To systematically review the literature on generic antiepileptic drugs (AEDs), evaluate the efficacy and safety of generic AED substitution, and perform pharmacokinetic (PK) analysis using the American Academy of Neurology (AAN) scheme to classify evidence. Data Sources: PubMed and Cumulative Index to Nursing and Allied Health Literature searches from January 1, 1980, to October 15, 2010, were performed using the search terms anticonvulsant, antiepileptic drug, carbamazepine, divalproex, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phénobarbital, Phenytoin, p

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18

NAKAI, Kiyohito, Masahiko FUJITA, and Hiroyasu OGATA. "New Bioequivalence Studies : Individual Bioequivalence and Population Bioequivalence." YAKUGAKU ZASSHI 120, no. 11 (2000): 1201–8. http://dx.doi.org/10.1248/yakushi1947.120.11_1201.

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Ashraf, Muhammad Mudassar, Ijaz Javed, Bilal Aslam, and Tanweer Khaliq. "CEFIXIME." Professional Medical Journal 22, no. 07 (2015): 959–65. http://dx.doi.org/10.29309/tpmj/2015.22.07.1227.

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Cefixime is a third generation and orally acting cephalosporin. It is a cell wallsynthesis inhibitor and is well stable to presence of beta lactamase enzymes. Environmentaland genetic differences play a greater role in disposition kinetics of a drug. Objectives: Todetermine disposition kinetics of cefixime in local population and to evaluate the bioequivalenceof multinational and national brands of cefixime. Period: 2013-2014. Setting: Institute ofPharmacy, Physiology and Pharmacology, University of Agriculture, Faisalabad. Methods: Inpresent study disposition kinetics and bioequivalence of tw

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Gallegos-Catalán, Jonattan, Zachary Warnken, Tania F. Bahamondez-Canas, and Daniel Moraga-Espinoza. "Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process." Pharmaceutics 13, no. 7 (2021): 1051. http://dx.doi.org/10.3390/pharmaceutics13071051.

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Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalab

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shukla, Ajay. "Nifedipine 20 mg Brands' Bioequivalency and Bioavailability in Healthy Human Subjects." International journal of therapeutic innovation 2, no. 3 (2024): 0089–93. http://dx.doi.org/10.55522/ijti.v2i1.0021.

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Bioavailability and bioequivalence study for developing new drug product and for generating its alternatives these parameters plays a major role in this phase. Nifedipine (NFDP) is an orally active calcium channel blocker, antihypertensive property which reduces the risk of cardiovascular diseases. The goal of the current study is to assess in healthy human subjects the bioavailability and bioequivalency of NFDP 20 mg formulations following a single dosage administered while fasting. As a result, an open label, balanced, randomized, three-period single dose bioequivalency study of various NFDP

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Panigrahi, Dhananjay, Aditya Murthy, Shubham Jamdade, et al. "Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software." Generics and Biosimilars Initiative Journal 13, no. 1 (2024): 14–21. http://dx.doi.org/10.5639/gabij.2024.1301.003.

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Introduction: In this work, we present model guided development of a new Etoricoxib tablet formulation using a proprietary technology. Application of absorption modelling using GastroPlus to guide the product development process is presented. An integrated approach of using in vitro, modelling and in vivo pharmacokinetics (PK) data to demonstrate bioequivalence between newly developed formulation and the commercial formulation is presented. Methods: The MiSTTM technology is a combination of wetting-solubilizing agents with suspension-spray granulation technique. A physiologically-based biophar

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Hailu, Gebremedhin Solomon, Girma Belachew Gutema, Hailemichael Zeru Hishe, Yimer Said Ali, and Adissu Alemayehu Asfaw. "Comparative In vitro Bioequivalence Evaluation of Different Brands of Amoxicillin Capsules Marketed in Tigray, Ethiopia." International Journal of Pharmaceutical Sciences and Nanotechnology 6, no. 1 (2013): 1966–71. http://dx.doi.org/10.37285/ijpsn.2013.6.1.7.

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The availability of multisource generic brands of amoxicillin in the market today places health professionals and patients in a difficult situation about the choice of a suitable product among numerous generic brands. The purpose of this study was to estimate the bioequivalence of amoxicillin capsules marketed in Ethiopia using in vitro tests in order to determine their interchangeability. The in vitro dissolution study was carried out on the six brands of amoxicillin capsules according to USP guidelines. To compare the dissolution profiles, a difference factor (f1), similarity factor (f2), di

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Toehwé, Leonardo Henrique, Thiago Da Silva Honorio, Luiz Claudio Rodrigues Pereira da Silva, et al. "Comparison of in vitro, in vivo, and in silico bioavailability results of different prednisone tablet formulations to assess the feasibility of possible biowaiver." Ars Pharmaceutica (Internet) 62, no. 4 (2021): 358–70. http://dx.doi.org/10.30827/ars.v62i4.21029.

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Introduction: The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process. This work aims to compare in vitro, in silico, and in vivo data to establish if previously published prednisone oral tablet formulations are biowaiver candidates. Method: To achieve this goal, permeation studies were conducted on Caco-2 cells. A previous bioequivalence study between the test and the reference drug product was applied on an in silico evaluation using Gastroplus® to assess the bioequivalence of two other previously proposed formulati

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Kumisbek, Gulzina, David Vetchý, and Arshyn Kadyrbay. "Development of a New Bioequivalent Omeprazole Product." Medicina 60, no. 3 (2024): 427. http://dx.doi.org/10.3390/medicina60030427.

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Background and Objectives: The enteric form of omeprazole is one of the most commonly prescribed medications. Similarly to Europe, Kazakhstan relies on the localization of pharmaceutical drug production as one of its primary strategies to ensure that its population has access to affordable and good-quality medicines. This study comprehensively describes the technologically available development of bioequivalent delayed-release omeprazole. Materials and Methods: Various regimes and technological parameters were tested on laboratory- and production-scale equipment to establish a technical proces

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Dhar, Rajashree, Ashish Prasad, and Vivekanandan Annadurai. "Triple Fixed-dose combination of Dapagliflozin, Sitagliptin, and Metformin for People with Type 2 Diabetes in Indian Settings." Journal of Drug Delivery and Therapeutics 14, no. 9 (2024): 66–73. http://dx.doi.org/10.22270/jddt.v14i9.6692.

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Objective: This study assessed the bioequivalence of a fixed-dose combination (FDC) therapy containing extended-release Metformin (Metformin XR), Dapagliflozin, and Sitagliptin for treating type 2 diabetes (T2D). The objective was to compare the absorption rate and extent of the FDC with two reference products: Sitagliptin 100mg tablets (R1) and a combination of Dapagliflozin 10mg plus Metformin 1000mg extended-release tablets (R2) in healthy adult males under fed conditions. Methods: An open-label, randomized, cross-over study was conducted with 24 healthy male participants. Each participant

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Suárez, Encarnación C., and Jana R. Grippi. "Comparative Bioavailability and Safety of Two Intramuscular Ceftriaxone Formulations." Annals of Pharmacotherapy 30, no. 11 (1996): 1223–26. http://dx.doi.org/10.1177/106002809603001101.

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OBJECTIVE: To determine if two ceftriaxone solutions of different concentrations are bioequivalent when administered intramuscularly. DESIGN: Double-blind, single-dose, two-period, randomized crossover study. SETTING: A clinical research center. SUBJECTS: Seventeen healthy volunteers. INTERVENTION: Ceftriaxone 500 mg administered in either 2 or 1.4 mL of lidocaine 1% solution, with final ceftriaxone concentrations of 250 and 350 mg/mL, respectively. MAIN OUTCOME MEASURES: Blood samples were assayed for ceftriaxone concentrations with HPLC and pharmacokinetic parameters were calculated from the

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Barakat, Nahla S., Nawal M. Khalafallah, and Said A. Khalil. "Comparative Bioavailabilitv Studv of Two Brands of Terbutaline Sulphate Tablets in Healthy Human Volunteers." Scientia Pharmaceutica 72, no. 3 (2004): 227–37. http://dx.doi.org/10.3797/scipharm.aut-04-19.

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The purpose of this study was to evaluate the bioavailability of locally produced 2.5 mg terbutaline sulphate tablets (brand A ) relative to a reference product, Bricanyl 2.5 mg tablets (brand 6). The study was a single dose 5 mg randomized crossover one in 15 healthy volunteers in the fasting state. Urine was collected at intervals of 24 h. Total terbutaline excreted in urine as unchanged drug and as conjugates (sulphate and glucuronide) was determined by a developed and validated HPLC method. In-vitro characteristics of both brands were similar. Based on percent of the dose excreted in urine

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Patterson, Scott D., and Byron Jones. "Bioequivalence." International Journal of Pharmaceutical Medicine 20, no. 4 (2006): 243–50. http://dx.doi.org/10.2165/00124363-200620040-00004.

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Noskov, S. M., A. N. Arefeva, V. V. Banko, et al. "Semaglutide for the treatment of obesity: Results of two open randomized pharmacokinetic studies." Meditsinskiy sovet = Medical Council, no. 16 (November 1, 2024): 216–22. http://dx.doi.org/10.21518/ms2024-346.

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Introduction. Obesity is a growing public health issue in Russia, increasing the risk of cardiovascular diseases, type 2 diabetes, and hypertension. Controlling obesity involves lifestyle changes and pharmacotherapy. Semaglutide, an effective obesity treatment, stimulates insulin production and reduces appetite. Developing a generic semaglutide preparation will improve its availability in Russia.Aim. To study the comparative pharmacokinetics, bioequivalence, safety and tolerability of semaglutide products GP40331 and Wegovy using concentrations of 0.68 and 3.2 mg/ml in healthy volunteers under

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González-Álvarez, Isabel, Bárbara Sánchez-Dengra, Raquel Rodriguez-Galvez, et al. "Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients." Pharmaceutics 14, no. 12 (2022): 2565. http://dx.doi.org/10.3390/pharmaceutics14122565.

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Some years ago, excipients were considered inert substances irrelevant in the absorption process. However, years of study have demonstrated that this belief is not always true. In this study, the reasons for a bioequivalence failure between two formulations of silodosin are investigated. Silodosin is a class III drug according to the Biopharmaceutics Classification System, which has been experimentally proven by means of solubility and permeability experiments. Dissolution tests have been performed to identify conditions concordant with the non-bioequivalent result obtained from the human bioe

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Mwaikambo, B., F. Borgions, K. Allosery, J. Noukens, and C. De Muynck. "P.106 Investigating the bioequivalence, injection speed, and usability of subcutaneous efgartigimod PH20 administration using a prefilled syringe." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 52, s1 (2025): S40. https://doi.org/10.1017/cjn.2025.10263.

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Background: Efgartigimod, a human immunoglobulin G1 (IgG1) antibody Fc fragment, reduces IgG levels through neonatal Fc receptor blockade. Efgartigimod PH20 SC (1000-mg fixed dose, coformulated with recombinant human hyaluronidase PH20) is provided in a vial administered via a separate syringe (V+S). Here, we investigate bioequivalence, safety, and tolerability of efgartigimod PH20 SC administered via prefilled syringe (PFS) vs V+S in healthy participants. Methods: Bioequivalence was assessed in a phase 1, open-label study. Healthy participants (n=72) were randomized to receive one injection o

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Khokhlov, A. L., D. Yu Grebenkin, E. K. Faeva, et al. "Bioequivalence study of fixed-dose combination Losartan + amlodipine + rosuvastatin Sanofi in comparison with coadministered fixed- dose combination Lozap® AM and monocomponent drug Crestor® in healthy subjects." Pharmacokinetics and Pharmacodynamics, no. 1 (May 1, 2022): 61–74. http://dx.doi.org/10.37489/2587-7836-2022-1-61-74.

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Introduction. The advantages of fixed-dose combination losartan + amlodipine + rosuvastatin compared to mono-drugs and two-component combinations are to increase the therapeutic efficacy, to reduce the cost of the product and to make the drug easier to take which helps to improve patient adherence to therapy. A bioequivalence study of the three-component fixed-dose combinations Losartan + amlodipine + rosuvastatin Sanofi with coadministered Lozap® AM (Losartan+Amlodipine) and Crestor® (Rosuvastatin) was conducted. Aim. The purpose of the bioequivalence trial was a comparative study of the phar

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Pérez, Milena, William Cárdenas, Gloria Ramírez, Mauricio Pérez, and Piedad Restrepo. "A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets." Colombia Medica 37, no. 2 (2006): 107–20. http://dx.doi.org/10.25100/cm.v37i2.421.

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Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC) and maximum concentration (Cmax). In this case, bioequivalence will be evaluated and the bioavailability of valsarta

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Vasilyuk, V. B., A. Yu Boroduleva, P. D. Sobolev, et al. "BIOEQUIVALENCE STUDY OF GENERIC MOLNUPIRAVIR IN HEALTHY VOLUNTEERS." Pharmacy & Pharmacology 10, no. 6 (2023): 562–72. http://dx.doi.org/10.19163/2307-9266-2022-10-6-562-572.

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Molnupiravir is one of the drugs for the etiotropic therapy of a new coronavirus infection COVID-19. It has confirmed its clinical efficacy in the treatment of patients with mild and moderate COVID-19, including those who are at high risk of progressing to severe disease.The aim of the study was to evaluate bioequivalence of the generic drug molnupiravir ALARIO-TL and the original drug Lagevrio with a single oral administration in healthy volunteers.Materials and methods. This bioequivalence study was an open, randomized, two-period crossover study. In each of the two periods, volunteers recei

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Pednekar, Abhijit, Amit Gupta, and Sona Warrier. "The MeViDa Study: Bioequivalence Study of FDC of Dapagliflozin, Vildagliptin SR and Metformin SR in Healthy Indian Volunteers: A Randomized, Open-Label, Crossover Study." Journal of Drug Delivery and Therapeutics 14, no. 7 (2024): 1–5. http://dx.doi.org/10.22270/jddt.v14i7.6674.

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Objective: To assess the pharmacokinetics and bioequivalence of Dapagliflozin 10mg + Vildagliptin Sustained Release (SR) 100mg + Metformin SR 1000mg fixed dose combination (FDC) tablets with DAPAMAC V 10 (Dapagliflozin 10mg + Vildagliptin SR 100mg tablets) and Glycomet 1g (Metformin SR 1000 mg tablets) in healthy adult male subjects under fasting conditions. Material and Methods: This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study. Volunteers were randomized to receive either a test product or a reference prod

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PRADEEP, T. PAVAN, RANJITH KUMAR GATTU, ANIL KUMAR NARALASETTY, et al. "Bioequivalence study of ticagrelor in normal, healthy Indian subjects under fasting conditions." Heart India 11, no. 3 (2023): 124–29. http://dx.doi.org/10.4103/heartindia.heartindia_53_23.

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Objectives: The objectives of this study were to evaluate the bioequivalence and safety profiles of the test drug and reference drug of 90 mg ticagrelor tablets under fasting conditions. Methods: This was a randomized, blinded, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study in normal, healthy adults. Subjects were randomized to receive a single dose of test or reference drug (ticagrelor 90 mg oral) under fasting conditions with a 16-day washout period. The primary pharmacokinetic variables were peak plasma concentration (Cmax), area under the pla

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Chulavatnatol, Suvatna, Kumthorn Malathum, Sasisopin Kiertiburanakul, Kittisak Sripha, and Pojawon Lawanprasert. "Bioequivalence of indinavir capsules in healthy volunteers." Asian Biomedicine 4, no. 1 (2010): 95–101. http://dx.doi.org/10.2478/abm-2010-0011.

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Background: Indinavir, one component in the HAART regimen, plays an important role in the current treatment of HIV-infection and AIDS. Availability and accessibility of qualified generic indinavir to patients may be the keys for the success of treatment. Objective: Compare the rate and extent of absorption of a generic indinavir formulation with those of an original formulation in healthy Thai volunteers. Method: A randomized, two-period, two-treatment, two-sequence, crossover study with a two-week washout period was performed. A single dose of 2×400 mg indinavir capsules of each formulation w

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Salunke, Shashank, Ashish Birla, Sandip Chaudhari, et al. "A Two-Sequence, Four-Period, Crossover, Full-Replicate Study to Demonstrate Bioequivalence of Carbamazepine Extended-Release Tablets in Healthy Subjects under Fasting and Fed Conditions." Journal of Drug Delivery and Therapeutics 12, no. 3-S (2022): 164–68. http://dx.doi.org/10.22270/jddt.v12i3-s.5404.

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Carbamazepine is a first-line antiepileptic drug (AED) used for the treatment of partial and tonic-clonic seizures. We conducted an open label, balanced, randomized, two-treatment, two-sequence, four-period, single oral dose, full-replicate crossover study to assess and compare the bioequivalence of test product Carbamazepine extended release tablets USP 400 mg with reference product Tegretol®-XR 400 mg (Carbamazepine extended release tablets), respectively in healthy subjects under fasting and fed conditions. Blood samples were collected pre-dose and at regular intervals post-dose up to 240.0

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Kamdi, Sandesh P., and Prashant J. Palkar. "Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations." ISRN Pharmacology 2013 (February 7, 2013): 1–4. http://dx.doi.org/10.1155/2013/347457.

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The objective of this study was to investigate the bioequivalence of two formulations of 40 mg pantoprazole sodium enteric-coated tablets: Tripepsa as the test and Pantocid as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 1-month washout period in 25 healthy Indian volunteers. After drug administration, serial blood samples were collected over a period of 30 hours. Plasma pantoprazole concentrations were measured by high-performance liquid chromatography with UV detection. Pharmacokinetic parameters were analyzed ba

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YILMAZ, İsmet. "Bioequivalence, Bioequivalence Parameters, Study Types and Situations Which Are/Not Necessary." Bioequivalence & Bioavailability International Journal 7, no. 2 (2023): 1–4. http://dx.doi.org/10.23880/beba-16000202.

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In this review, short definition of bioequivalence, study types and situations which is/not necessary have been summarized. In the world, it is realized that the most valuable quality control testing is bioequivalence studies and the results of bioequivalence studies have been used as an important indicator by the authors of the subject.

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V, Khaowroongrueng. "Bioequivalence and Pharmacokinetics of Carvedilol (6.25 and 12.5 Mg Tablets) in Healthy Thai Volunteers." Bioequivalence & Bioavailability International Journal 5, no. 2 (2021): 1–8. http://dx.doi.org/10.23880/beba-16000156.

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The Government Pharmaceutical Organization (GPO) had developed the generic products of carvedilol 12.5 and 6.25 mg tablets as low-cost alternatives for patients and physicians to enhance patient adherence and accessibility to long-term use medications. Two bioequivalence studies were conducted to evaluate the bioequivalence between the test and reference products of carvedilol 12.5 mg and 6.25 tablets. The design for both studies was comparative randomized, open-label, single- dose, two-way crossover. Carvedilol and 4′-hydroxyphenyl carvedilol (active metabolite) concentrations in plasma were

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Liu, Yanmei, Jie Cheng, Liyu Liang, et al. "A single-dose, randomized crossover study in healthy Chinese subjects to evaluate pharmacokinetics and bioequivalence of two capsules of calcium dobesilate 0.5 g under fasting and fed conditions." PLOS ONE 18, no. 4 (2023): e0284576. http://dx.doi.org/10.1371/journal.pone.0284576.

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Objectives To compare the rate and extent of absorption of a launched generic calcium dobesilate capsule versus the branded reference formulation under fasting and fed conditions in healthy Chinese subjects, and to assess their bioequivalence and tolerability. Methods This single-dose, open-label, randomized-sequence, 2-period crossover bioequivalence study was conducted on healthy Chinese volunteers aged 18 to 45 years. Subjects received a single 0.5 g dose of calcium dobesilate capsule under fasting or fed conditions, with a 3-day washout period between doses of the test (T) and reference (R

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Patel, Nishi, Jimesh Shah, Amit Patel, and Ravish J. Patel. "Bioequivalence requirements of Pharmaceutical Products in US, Europe and Australia." International Journal of Drug Regulatory Affairs 10, no. 2 (2022): 56–61. http://dx.doi.org/10.22270/ijdra.v10i2.524.

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In the last three decades, the notion of bioequivalence has gotten a lot of attention as it has been applied to new branded and generic medications. Generic medications must meet the same quality, efficacy, and safety requirements. Conventional products should be therapeutically equal to the reference product and compatible. The evolution of regulatory standards for bioequivalence in the United States, Europe, and Australia are examined in this paper. There is no international harmonization of regulatory requirements for bioequivalence, but the scope of bioequivalence and statistical analysis

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Curry, Stephen H., John G. Gums, Lisa L. Williams, R. Whitney Curry, and Bernard B. Wolfson. "Levothyroxine Sodium Tablets: Chemical Equivalence and Bioequivalence." Drug Intelligence & Clinical Pharmacy 22, no. 7-8 (1988): 589–91. http://dx.doi.org/10.1177/106002808802200715.

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Two brands of levothyroxine sodium tablets were compared in vivo for bioequivalence in a double-blind, randomized study. The tablets were identical in levothyroxine content. Evaluation was by means of triiodothyronine (uptake), tetraiodothyronine, free thyroxine index, total triiodothyronine by radioimmunoassay, and thyroid-stimulating hormone measurements. No differences in clinical response were found in a study with a high statistical power. It was concluded that the two brands were bioequivalent because of chemical equivalence, use of micronized levothyroxine powder in tablet production wi

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Romodanovsky, D. P. "Relevant Issues of Planning Bioequivalence Studies of Drugs with a Narrow Therapeutic Range." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 10, no. 3 (2020): 201–10. http://dx.doi.org/10.30895/1991-2919-2020-10-3-201-210.

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In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivalence or therapeutic equivalence studies. In most cases, comparative pharmacokinetic studies and demonstration of bioequivalence between the test and the reference products are sufficient for this group of drugs. However, there is no established official definition in Russia for the group of drugs that are regarded as having a narrow therapeutic range. Evaluation of bioequivalence of such drugs has to be performed providing for narrower confidence intervals, which entails certain problems at the s

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Ducray, Francois, Carole Ramirez, Marie Robert, et al. "A bioequivalence study of a novel liquid and ready-to-use temozolomide oral suspension and temozolomide capsules in patients with primary tumors central nervous system malignancies." Journal of Clinical Oncology 40, no. 16_suppl (2022): e22008-e22008. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e22008.

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e22008 Background: Oral temozolomide capsule is approved for the treatment of glioma and malignant glioblastoma in adults and in Europe in children over 3-years. As recommended by international pediatric medical associations, temozolomide is also used for the treatment of high-risk relapsed or refractory neuroblastoma, a solid tumor affecting young children. Nevertheless, capsules are not adapted to the pediatric population leading caregivers to handle temozolomide capsules, which bears major risks (i.e. dose inaccuracy, temozolomide instability and exposure to cytotoxic drug). To overcome thi

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Ducray, Francois, Carole Ramirez, Marie Robert, et al. "A bioequivalence study of a novel liquid and ready-to-use temozolomide oral suspension and temozolomide capsules in patients with primary tumors central nervous system malignancies." Journal of Clinical Oncology 40, no. 16_suppl (2022): e22008-e22008. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e22008.

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e22008 Background: Oral temozolomide capsule is approved for the treatment of glioma and malignant glioblastoma in adults and in Europe in children over 3-years. As recommended by international pediatric medical associations, temozolomide is also used for the treatment of high-risk relapsed or refractory neuroblastoma, a solid tumor affecting young children. Nevertheless, capsules are not adapted to the pediatric population leading caregivers to handle temozolomide capsules, which bears major risks (i.e. dose inaccuracy, temozolomide instability and exposure to cytotoxic drug). To overcome thi

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Wang, Lu, Pengfei Zhao, Ting Luo, et al. "Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations." Clinical and Translational Science, September 17, 2023. http://dx.doi.org/10.1111/cts.13633.

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AbstractIn vivo pharmacokinetic simulations and virtual bioequivalence evaluation of cilostazol have not yet been described for humans. Here, we successfully developed a physiologically based absorption model to simulate plasma concentrations of cilostazol. In addition, virtual population simulations integrating dissolution of 0.3% sodium dodecyl sulfate water media were executed to evaluate the bioequivalence of test and reference formulations. Simulation results show that test and reference formulations were bioequivalent among 28 subjects, but not nine subjects, consistent with clinical stu

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Kollipara, Sivacharan, Rajkumar Boddu, Suribabu Bonda, et al. "Model integrated evidence approach for rational and safe formulation development: case of alfuzosin prolonged-release tablets." Journal of Applied Pharmaceutical Science, 2025. https://doi.org/10.7324/japs.2025.231215.

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The model integrated evidence (MIE) approach aims to utilize simulation tools like physiologically based biopharmaceutic model (PBBM) or physiologically based pharmacokinetic (PBPK) model for the development of new drugs and generic formulations. In the current case, MIE is utilized for developing rational and safe formulations for alfuzosin prolonged-release tablets. Due to the side effects of postural hypotension, it is required to develop a formulation that can have lesser yet bioequivalent Cmax. To support this, the PBBM model was developed using physicochemical, disposition, and dissoluti

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