Generic Drug Product Development
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Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2013-10-24
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-24 with Medical categories.
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2013-10-24
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-24 with Medical categories.
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2007-11-15
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-15 with Medical categories.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp
Drug Product Design And Performance
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Author : Victor F. Smolen
language : en
Publisher: Wiley-Interscience
Release Date : 1984
Drug Product Design And Performance written by Victor F. Smolen and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 1984 with Business & Economics categories.
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru
A Textbook On Generic Product Development For B Pharmacy Students
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Author : Dr. T. Naga Aparna,B. Deepthi ,Dr. Pittu Vishnu Priya ,Dr. R. Prasanthi ,Dr. Perli Kranti Kumar
language : en
Publisher: Shashwat Publication
Release Date : 2025-07-31
A Textbook On Generic Product Development For B Pharmacy Students written by Dr. T. Naga Aparna,B. Deepthi ,Dr. Pittu Vishnu Priya ,Dr. R. Prasanthi ,Dr. Perli Kranti Kumar and has been published by Shashwat Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-07-31 with Fiction categories.
This book provides a comprehensive insight into the process of generic drug product development, guiding readers through each critical phase from conceptualization to regulatory approval. Developed to align with academic curricula and industrial standards, the text serves as a valuable resource for pharmacy students, regulatory professionals, and formulation scientists. The content is systematically organized into five units, beginning with the historical background and legal framework of generic drug development, including a detailed discussion on the Hatch-Waxman Act and its implications. Subsequent chapters delve into the design and optimization of dosage forms to ensure therapeutic equivalence with reference listed drugs (RLDs), covering aspects such as formulation, process development, and packaging considerations. The book also emphasizes analytical method development for verification and validation at various stages—from raw material to finished dosage forms. It elaborates on stability testing protocols under various environmental conditions to determine product shelf life, and scale-up strategies for manufacturing and exhibit batch execution. A dedicated section is provided on bioequivalence study design, regulatory criteria, and in-vitro techniques used to demonstrate bioequivalence. Further, the book introduces the electronic Common Technical Document (eCTD), detailing its modular structure and significance in regulatory submissions. The final unit explores the drug approval process in both India and the United States, offering comparative insights for global regulatory compliance. Key Features: • Covers the complete lifecycle of generic drug development • Integrates formulation science, quality assurance, and regulatory affairs • Includes discussion on global regulatory systems with a focus on USFDA and CDSCO • Provides foundational knowledge and practical strategies for dossier preparation and submission This book equips readers with the necessary knowledge and tools to effectively contribute to the generic pharmaceutical industry, ensuring quality, efficacy, and regulatory compliance in drug development projects.
Comprehensive Guide To Generic Product Development
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Author : Veerareddy Prabhakar Reddy
language : en
Publisher: Notion Press
Release Date : 2024-11-26
Comprehensive Guide To Generic Product Development written by Veerareddy Prabhakar Reddy and has been published by Notion Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-26 with Reference categories.
Comprehensive Guide to Generic Product Development: Theory and Practice By Veerareddy Prabhakar Reddy and Muralidhar Rao Akkaladevi Mastering the Science and Art of Generic Drug Development This definitive guide is an essential resource for pharmaceutical professionals, academicians, and students seeking to navigate the intricate landscape of generic product development. Comprehensive Guide to Generic Product Development: Theory and Practice seamlessly blends foundational concepts with cutting-edge methodologies to provide a holistic understanding of the subject. A Detailed Exploration of the Subject Gain insight into formulation design, process optimization, and regulatory pathways. Understand the pharmacokinetics, bioequivalence studies, and analytical validations critical for successful product approval. Explore stability testing protocols, packaging development, and the role of Quality by Design (QbD) in ensuring product efficacy and safety. Delve into real-world examples, case studies, and global regulatory perspectives that emphasize practical applications in a competitive marketplace. Why This Book Stands Out Written by experts with decades of experience, this guide provides a clear, structured, and accessible framework, making it an indispensable companion for professionals and learners in the pharmaceutical sciences.
Applied Biopharmaceutics Pharmacokinetics Seventh Edition
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Author : Leon Shargel
language : en
Publisher: McGraw Hill Professional
Release Date : 2015-11-22
Applied Biopharmaceutics Pharmacokinetics Seventh Edition written by Leon Shargel and has been published by McGraw Hill Professional this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-22 with Medical categories.
The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics—now fully updated. Explains how to detect clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them Helps you critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency Chapters have been revised to reflect the latest clinical perspectives on drug performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy The field’s leading text for more than three decades, Applied Biopharmaceutics & Pharmacokinetics gets you up to speed on the basics of the discipline like no other resource. Practical problems and clinical examples with discussions are integrated within each chapter to help you apply principles to patient care and drug consultation situations. In addition, outstanding pedagogy, including chapter objectives, chapter summaries, and FAQs, plus additional application questions, identify and focus on key concepts. Written by authors who have both academic and clinical experience, Applied Biopharmaceutics & Pharmacokinetics shows you how to use raw data and formulate the pharmacokinetic models and parameters that best describe the process of drug absorption, distribution, and elimination. The book also helps you work with pharmacokinetic and biopharmaceutic parameters to design and evaluate dosage regimens of drugs. In the seventh edition of this must-have interactive learning tool, most of the chapters are updated to reflect our current understanding of complex issues associated with safe and efficacious drug therapy.
Shargel And Yu S Applied Biopharmaceutics Pharmacokinetics 8th Edition
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Author : Murray P. Ducharme
language : en
Publisher: McGraw Hill Professional
Release Date : 2022-01-24
Shargel And Yu S Applied Biopharmaceutics Pharmacokinetics 8th Edition written by Murray P. Ducharme and has been published by McGraw Hill Professional this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-24 with Medical categories.
The authoritative textbook on the principles and practical applications of biopharmaceutics and pharmacokinetics Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics has been the standard textbook in its field for over 40 years. This eighth edition includes recent scientific developments in the field and embodies the collective contribution of experts with deep knowledge and experience in the selected subject areas. Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition provides the reader with a fundamental understanding of biopharmaceutics and pharmacokinetics principles that can be applied to patient drug therapy and rational drug product development. Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition has been expanded and revised to include advancements in biopharmaceutics and pharmacokinetics. The chapter sequence has been reorganized into four main sections, providing a more logical sequence for students. The textbook starts with fundamental concepts, followed by application of these principles to optimize drug therapy and to the rational development of drug products. Each chapter includes theoretical concepts with practical examples and clinical applications. Frequently asked questions provide a discussion of overall concepts. Features: Expanded and revised chapters to include scientific advances in biopharmaceutics and pharmacokinetics Four main sections providing a natural buildup of knowledge: introduction to biopharmaceutics and pharmacokinetics, fundamentals of biopharmaceutics, pharmacokinetic calculations, clinical pharmacokinetics and pharmacodynamics, and biopharmaceutics and pharmacokinetics in drug product development Additional chapters for this edition include: o Physiological factors related to drug absorption o Approaches to pharmacokinetics and pharmacodynamics calculations o Novel and complex dosage Forms o Clinical Development and Therapeutic Equivalence of Generic Drug and Biosimilar Products o Pharmacokinetics and Pharmacodynamics in Clinical Drug Product Development Additional information on drug therapy, drug product performance, and other related topics Frequently asked questions, practice problems, clinical examples and learning questions