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Готові списки джерел за темами / Finished Pharmaceutical Product

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Добірка наукової літератури з теми "Finished Pharmaceutical Product"

Автор: Grafiati

Опубліковано: 3 червня 2025

Оновлено: 31 липня 2025

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Статті в журналах з теми "Finished Pharmaceutical Product"

1

Chandel, Vikas, Hemendra Pratap Singh, Nilesh Rarokar, and Kamlesh Wadher. "Stabilization of the pharmaceutical finished dosages form by using various techniques." Journal of Drug Delivery and Therapeutics 14, no. 6 (2024): 44–50. http://dx.doi.org/10.22270/jddt.v14i6.6619.

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The stabilization of pharmaceuticals means that the drug product is physically, chemically and microbiologically stable at the recommended storage condition throughout the predefined shelf life of the product. Pharmaceutical formulations irrespective of its physical states have been used for their efficacy and safety so for as its therapeutic activity is concern. Stability of dosage forms is the ability of drugs to remains unaffected by environmental condition viz. temperature, humidity and microbiological contamination. This research work is an attempt to stabilize the drug product at control

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2

Ishita Sharma, Kumud Upadhyay, and Sushil Giri. "Prioritizing metal detector for finished pharmaceutical formulation: Manufacturing safe, quality product." World Journal of Advanced Research and Reviews 16, no. 3 (2022): 482–89. http://dx.doi.org/10.30574/wjarr.2022.16.3.1339.

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Background: The pharmaceutical metal detector is a device to detect metal as well as non-metal contaminants of large size in the pharmaceutical dosage form. The detection of unwanted metal (contaminant) is important to produce a high quality of the dosage form. Main body: Pharmaceutical dosage forms are highly sensitive to the environment to which they are surrounded. It is challenging to keep a product in its original form throughout its shelf life. These metals find entry in the pharmaceutical formulation during various phases of manufacturing while passing through pipelines, sieves, conveyo

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3

Rafael, Bence, Nóra Kuruczleki, and József Gál. "The way of the pharmaceutical ingredients to the finished pharmaceutical form." Analecta Technica Szegedinensia 12, no. 2 (2018): 24–31. http://dx.doi.org/10.14232/analecta.2018.2.24-31.

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The modern pharmaceutical industry is a strictly controlled area. Both national and international rules apply, but none of these deals with logistical issues arising from the manufacture of the product. Following the path of a drug, it is possible to get acquainted with the problems that arise and their solution. The drug is much more than a common product. The drug is a product of confidence, which is provided with information. It defines its quality as well, to comply with the relevant directives and standards in the manufacture of, and that the enclosed information is sent to the user

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4

Ishita, Sharma, Upadhyay Kumud, and Giri Sushil. "Prioritizing metal detector for finished pharmaceutical formulation: Manufacturing safe, quality product." World Journal of Advanced Research and Reviews 16, no. 3 (2022): 482–89. https://doi.org/10.5281/zenodo.7902304.

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<strong>Background: </strong>The pharmaceutical metal detector is a device to detect metal as well as non-metal contaminants of large size in the pharmaceutical dosage form. The detection of unwanted metal (contaminant) is important to produce a high quality of the dosage form. <strong>Main body</strong>: Pharmaceutical dosage forms are highly sensitive to the environment to which they are surrounded. It is challenging to keep a product in its original form throughout its shelf life. These metals find entry in the pharmaceutical formulation during various phases of manufacturing while pas

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5

Varsha, Kshirsagar. "IN-PROCESS QUALITY CONTROL: A SYSTEMATIC APPROACH TO CONTROL CRITICAL STEPS IN FINISHED PHARMACEUTICAL PRODUCTS." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 01 (2017): 7369–73. https://doi.org/10.5281/zenodo.1006759.

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Анотація:

The main objective of pharmaceutical industry is to manufacture the quality products. Quality cannot be tested in the product it should be built- in by design and verified during the process with careful attention to the extent possible rather than depend alone on the end product testing. Many factors are responsible to give assurance of the quality of product. One of them is In-Process Quality Control Checks (IPQC). Critical points of all stages of the manufacturing process being checked by In-Process Quality Control according to standard operation procedures (SOPs). These applied SOPs vary f

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6

Zmysłowski, Adam, Iza Książek, and Arkadiusz Szterk. "N-Nitrosodimethylamine Contamination in the Metformin Finished Products." Molecules 25, no. 22 (2020): 5304. http://dx.doi.org/10.3390/molecules25225304.

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A GC–MS/MS method with EI ionization was developed and validated to detect and quantify N-nitrosodimethylamine (NDMA) and seven other nitrosamines in 105 samples of metformin tablets from 13 different manufactures. Good linearity for each compound was demonstrated over the calibration range of 0.5–9.5 ng/mL. The assay for all substances was accurate and precise. NDMA was not detected in the acquired active pharmaceutical ingredient (API); however, NDMA was detected in 64 (85.3%) and 22 (91.7%) of the finished product and prolonged finished product samples, respectively. European Medicines Agen

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7

Md., Sahab Uddin, Al Mamun Abdullah, Tanvir Kabir Md., et al. "Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications." Journal of Advances in Medical and Pharmaceutical Sciences 14, no. 2 (2017): 1–17. https://doi.org/10.9734/JAMPS/2017/33924.

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The therapeutically performance of the pharmaceuticals must be constant and expectable. In order to claim a pharmaceutical to be a quality drug, it must fulfill certain standards and specifications. The quality of pharmaceuticals is strongly related to the patient’s well-being. Quality control (QC) is an historical process in which proof is obtained that the appropriate level of quality has been achieved. QC can have no effect on the quality of the pharmaceuticals. It is merely a measuring process. QC must ensure that all the finished products contain active ingredients that comply with the qu

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Smekhova, I. E., L. V. Shigarova, I. A. Narkevich, E. V. Flisyuk, and V. D. Meteleva. "Documentation of Pharmaceutical Development. Part 2. Quality System Documents." Drug development & registration 10, no. 2 (2021): 147–53. http://dx.doi.org/10.33380/2305-2066-2021-10-2-147-153.

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Introduction. In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form (including a primary packaging system); create documentation for various stages of product development; validate analytical methods and technological processes. Information obtained in the course of experimental research and development of a medicinal product is included in the registration dossier. Documenting a pharmaceutical development allows you to systematize knowledge about monitoring

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9

Ghimire, Prakash, Abinash Chandra Shrestha, Sandhya Pandey, Bidur Chapagain, and Samir Dhakal. "Pharmacopoeial comparison of in-process and finished product quality control test for pharmaceutical tablets." GSC Biological and Pharmaceutical Sciences 11, no. 3 (2020): 155–65. https://doi.org/10.5281/zenodo.4271316.

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Анотація:

All Pharmaceutical industries endeavour to produce good quality products which are achieved by allowing in-process and finished product quality control approaches. In-process quality control is concepts that are carried out before, after and during production covering all steps, counting the establishment of specifications, sampling, relevant testing and analytical clearance assuring that the intermediates, packaging materials and finished pharmaceutical tablets conform with approved specifications or standard for efficacy, safety and elegance which assure the consumer that the products perfor

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10

Elmadhoun, Bassam, Rawidh Alsaidalani, and Frank Burczynski. "Quality Risk Management in the Final Operational Stage of Sterile Pharmaceutical Manufacturing: A Case Study Highlighting the Management of Sustainable Related Risks in Product Sterilization, Inspection, Labeling, Packaging, and Storage Processes." Sustainability 17, no. 4 (2025): 1670. https://doi.org/10.3390/su17041670.

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Quality risk management, commonly known as QRM, is designed to systematically assess, control, communicate, and review potential risks at every stage of the pharmaceutical manufacturing process. The preservation of consistent product quality across the entirety of the product’s life cycle is of paramount importance. The aim of this article is to formulate a best practice guide that will assist pharmaceutical manufacturers in comprehending and implementing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9: quality risk management pr

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Більше джерел

Дисертації з теми "Finished Pharmaceutical Product"

1

Zilker, Markus [Verfasser], and Ulrike [Gutachter] Holzgrabe. "The stability of finished pharmaceutical products and drug substances beyond their labeled expiry dates / Markus Zilker ; Gutachter: Ulrike Holzgrabe." Würzburg : Universität Würzburg, 2019. http://d-nb.info/1187140406/34.

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2

Zilker, Markus. "The stability of finished pharmaceutical products and drug substances beyond their labeled expiry dates." Doctoral thesis, 2019. https://nbn-resolving.org/urn:nbn:de:bvb:20-opus-180695.

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Анотація:

Upon approval of a drug, the stability of the API and the FPP has to be studied intensively because it determines the shelf-life. If a drug is found to be stable, the expiry date is arbitrary set to five years at the maximum, if a drug tends to undergo degradation, the expiry date is set shorter. The drug product must comply with predefined specifications in accordance with the ICH guidelines Q6A and Q6B during its entire market life. The content of the active substance is required to be within a specification of 95–105% of its labeled claim until expiry corresponding to the ICH guideline Q1A(

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Частини книг з теми "Finished Pharmaceutical Product"

1

Nahler, Gerhard. "finished product." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_563.

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2

Syed Asif, Erfan, and Shahid Bader Usmani. "Physical Testing of Raw Materials, Intermediate, and Finished Products." In Basics of Pharmaceutical Manufacturing and Quality Operations. CRC Press, 2024. http://dx.doi.org/10.1201/9781003366393-5.

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3

"Control Tests on the Finished Product." In International Pharmaceutical Product Registration. CRC Press, 2016. http://dx.doi.org/10.3109/9781420081831-21.

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4

Jamal, Sharib. "Pharmaceutical Mfg Plant." In A Text Book of Pharmaceutics for I Year Diploma in Pharmacy. THINKPLUS PHARMA PUBLICATIONS, 2024. http://dx.doi.org/10.69613/4qt8e703.

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Анотація:

Pharmaceutical manufacturing plants are complex facilities designed to produce high-quality medicinal products in compliance with regulatory standards. This section provides an overview of the key components and considerations in designing and operating a pharmaceutical manufacturing plant. The layout and design principles of manufacturing facilities, including material and personnel flow, are discussed with emphasis on contamination control and operational efficiency. Various production areas, such as dispensing, granulation, compression, and packaging, are explored along with their specific

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5

Voleti, Vijaya Kumar. "Quality Control and Quality Assurance." In A Text Book of Pharmaceutics for I Year Diploma in Pharmacy. THINKPLUS PHARMA PUBLICATIONS, 2024. http://dx.doi.org/10.69613/cwp2pp98.

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Анотація:

Quality Control (QC) and Quality Assurance (QA) are integral components of pharmaceutical manufacturing, ensuring the consistency, safety, and efficacy of drug products. This section explores the principles and practices of QC and QA in the pharmaceutical industry. The distinction between QC and QA is clarified, with QC focusing on product testing and QA encompassing broader quality management systems. Various aspects of quality control are examined, including raw material testing, in-process controls, and finished product analysis. Analytical techniques commonly used in pharmaceutical QC, suc

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6

Khan, Amjad, Shabnam Nazir, Hamad S. Alyami, and Aman Ullah. "SeDeM-ODT Expert System: A Solution to Challenges in Characterization of Pharmaceutical Powders and Powdered Material." In Advanced Functional Materials. IntechOpen, 2020. http://dx.doi.org/10.5772/intechopen.92444.

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In the field of pharmaceutical sciences, material characterization has been a focus of research as properties of the powder ingredients govern characteristics of the finished dosage form. It has been a tedious and time-consuming job to develop a correlation between the characteristics of powder material and final dosage form. Extensive experimentation is carried out at different stages of formulation development to optimize the final blend and produce a product fulfilling official requirements. Various approaches have been applied for the purpose with varying degree of applications. SeDeM-ODT

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7

Balanagu, Haranatha Babu, Tatavarti SVS Gopala Krishna, Ramesh Cheruvu, and Buchi N. Nalluri. "Development and Validation of HPLC Method for Quantification of Parecoxib in Parecoxib Injection." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00199.

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The purpose of the present study was to evaluate and optimize lyophilization cycle time for the manufacturing of Parecoxib Injection than reported longer lyophilization cycle times. Optimization of lyophilization cycle time reduces the manufacturing costs since lyophilization process involves longer times which incurs cost to the finished product. Optimization of lyophilization cycle was done by using inputs from the results of Differential Scanning Calorimetry (DSC), Differential Thermal Analysis (DTA) and Impedance analysis. HPLC method was developed for quantification of Parecoxib Active Ph

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8

Boltovska, Liudmyla. "CURRENT TRENDS IN THE DEVELOPMENT OF THE MEAT PRODUCT SUBCOMPLEX OF UKRAINE IN THE CONTEXT OF EUROPEAN INTEGRATION." In Modernization of research area: national prospects and European practices. Publishing House “Baltija Publishing”, 2022. http://dx.doi.org/10.30525/978-9934-26-221-0-3.

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Among the branches of agriculture, animal husbandry itself is a source of important food products for humans: milk, meat, eggs, and for industry (food, light pharmaceutical, etc.) supplies various types of raw materials. The increase in live weight produced in animal husbandry in the agro-industrial complex of Ukraine is formed in the meat product subcomplex, which unites producers of agricultural (livestock) products, trade organizations and meat processing enterprises in the process of raising livestock and poultry, processing and selling finished products. The subject of research is a set o

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9

Faisal Bokhari, Fawzi, and Ashwag Albukhari. "Design and Implementation of High Throughput Screening Assays for Drug Discoveries." In High-Throughput Screening for Drug Discovery [Working Title]. IntechOpen, 2021. http://dx.doi.org/10.5772/intechopen.98733.

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Анотація:

The process of drug discovery is challenging and a costly affair. It takes about 12 to 15 years and costs over $1 billion dollars to develop a new drug and introduce the finished product in the market. With the increase in diseases, virus spread, and patients, it has become essential to invent new medicines. Consequently, today researchers are becoming interested in inventing new medicines faster by adopting higher throughput screening methods. One avenue of approach to discovering drugs faster is the High-Throughput Screening (HTS) method, which has gained a lot of attention in the previous f

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10

Briggs, K. T., M. B. Taraban, and Y. B. YU. "Using Water Proton NMR to Characterize Aluminum-adjuvanted Vaccines." In Magnetic Resonance and its Applications in Drug Formulation and Delivery. Royal Society of Chemistry, 2024. http://dx.doi.org/10.1039/9781788019996-00213.

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wNMR, which stands for water proton nuclear magnetic resonance, is an emerging noninvasive analytical technology for pharmaceutical manufacturing and product inspection. In wNMR, the NMR signal from water protons is used to assess the physicochemical status of the solutes dissolved or suspended in water. The primary experimental outputs in wNMR are the longitudinal and transverse relaxation rates of water protons, R1(1H2O) and R2(1H2O). Aluminum-adjuvanted vaccines include some of the most commonly used vaccines and contain micron-sized aluminum salt particles, with antigens adsorbed to the pa

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Тези доповідей конференцій з теми "Finished Pharmaceutical Product"

1

Sibychan, Jerrin Job, Nicola Sorace, Jason Melnick, et al. "Use of Discrete Element Method to Troubleshoot Aesthetic Defects in Pharmaceutical Tablets." In Foundations of Computer-Aided Process Design. PSE Press, 2024. http://dx.doi.org/10.69997/sct.148066.

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Pharmaceutically elegant tablets are an expectation from pharmacists, health care providers and consumers for solid oral dosage forms. The presence of non-aesthetically pleasing defects in solid oral dosage forms can result in complaints back to the manufacturer and potentially non-compliance with medicines. The purpose of this study was to simulate and analyze the design of a tablet core and the aqueous film-coating process, to gain a better understanding of tablet defect generation, and to help eliminate the defects from the finished product. This evaluation employs Discrete Element Method (

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2

Ahluwalia, Hira, and Brian Uhlenkamp. "The Influence of Microstructure in the Fabrication and Electropolish Finish of Corrosion Resistant Equipment for the Bio-Pharmaceutical Industry." In CORROSION 2007. NACE International, 2007. https://doi.org/10.5006/c2007-07698.

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Abstract With today’s emphasis on process and product safety and compliance to Federal Regulations such as Title 21, CFR 211.65, selection of suitable materials of construction for the bio-technology and pharmaceutical industries is a critical step in designing or modifying plant equipment. Selecting the material of construction is only the first step, ensuring that the selected material meets the metallurgical and corrosion resistance performance that is expected is a very important second step. This paper discusses the reason for the high quality microstructural requirements for equipment de

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3

Frantsen, J. E., T. Mathiesen, J. Rau, J. Terävä, P. Björnstedt, and B. Henkel. "Effects of Gas Atmosphere and Surface Quality on Rouging of Three Stainless Steels in WFI." In CORROSION 2003. NACE International, 2003. https://doi.org/10.5006/c2003-03074.

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Abstract The pharmaceutical industry has for a long time been troubled by red-brown to dark violet deposits in distillation columns, storage vessels and distribution systems for water for injection (WFI), hot purified water, and clean steam. This phenomenon is known as rouging due to the visual appearance of the deposits that basically are stainless steel corrosion products. The affected installations are mostly fabricated from the austenitic stainless steel grade AISI 316L. The exact mechanism for rouge formation is not fully understood. However, it is widely reported that the phenomenon is c

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4

Chan, Kiki, Gladys Olubowale, Levente Diosady, and Yu-Ling Cheng. "Attrition of fully hydrogenated soybean oil-coated micronutrient granules during mixing." In 2022 AOCS Annual Meeting & Expo. American Oil Chemists' Society (AOCS), 2022. http://dx.doi.org/10.21748/iwnz7321.

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Fully hydrogenated soybean oil (FHSBO) is a versatile coating material for food and pharmaceutical products. Its neutral taste, oxidative and thermal stability, and hydrophobicity, makes it an ideal physical barrier against moisture and oxygen. As a coating on granular foods, FHSBO also prevents undesirable interactions between the coated granules and other components in the product matrix. However, during mixing processes, impact from the mixer impellers and abrasion from the other ingredients can lead to chipping or wear on FHSBO coatings, which lowers the quality of the finished products. U

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