Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
Generic Drug Product Development
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Inside This Book
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First Sentence:
A generic drug product, also referred to as a multisource pharmaceutical product, is considered to be "essentially similar" (1) or bioequivalent (2) to an innovator (brand name) product. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
labeling reviewer, granulating vehicle, court decision trigger, testing time points, reference listed drug, innovator drug product, updated batch records, inspectional history, bracketing design, generic drug product, target analyte peak, oral drug products, drug exclusivity, pharmacokinetic report, matrixing designs, bioanalytical data, suitability petitions, prior approval supplement, blending validation, accelerated stability data, approved drug product, innovator product, solid oral dosage forms, dissolution test method, exhibit batch Key Phrases - Capitalized Phrases (CAPs): (learn more)
Orange Book, United States, Brand Lot, Hatch-Waxman Amendments, Office of Generic Drugs, New York, Pharm Sci, Cosmetic Act, Marcel Dekker, Approved Drug Products, Federal Food, Drug Dev Ind Pharm, Pharm Res, Federal Register, Code of Federal Regulations, Immediate Release Solid Oral Dosage Forms, Drug Inf, Fed Regist, Fishers Lane, Division Director, Freedom of Information, Health Canada, Office of Compliance, The International Conference, Computer Media New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
A generic drug product, also referred to as a multisource pharmaceutical product, is considered to be "essentially similar" (1) or bioequivalent (2) to an innovator (brand name) product. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
labeling reviewer, granulating vehicle, court decision trigger, testing time points, reference listed drug, innovator drug product, updated batch records, inspectional history, bracketing design, generic drug product, target analyte peak, oral drug products, drug exclusivity, pharmacokinetic report, matrixing designs, bioanalytical data, suitability petitions, prior approval supplement, blending validation, accelerated stability data, approved drug product, innovator product, solid oral dosage forms, dissolution test method, exhibit batch Key Phrases - Capitalized Phrases (CAPs): (learn more)
Orange Book, United States, Brand Lot, Hatch-Waxman Amendments, Office of Generic Drugs, New York, Pharm Sci, Cosmetic Act, Marcel Dekker, Approved Drug Products, Federal Food, Drug Dev Ind Pharm, Pharm Res, Federal Register, Code of Federal Regulations, Immediate Release Solid Oral Dosage Forms, Drug Inf, Fed Regist, Fishers Lane, Division Director, Freedom of Information, Health Canada, Office of Compliance, The International Conference, Computer Media New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 100
books:
See all 100 books this book cites
5
books
cite this book:
- Approved Drug Products With Therapeutic Equivalence Evaluations on 4 pages
- New Drug Approval Process, Fourth Edition, Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) by Richard Guarino on 4 pages
- Pharmaceutical Statistics: Practical and Clinical Applications, Fourth Edition, Revised and Expanded (Drugs and the Pharmaceutical Sciences) by Sanford Bolton on 4 pages
- Modern Pharmaceutics by Gilbert S. Banker on 4 pages
- Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Sciences Series, Vol 78) by Sidney H. Willig in Front Matter (1), Front Matter (2), and Front Matter (3)
See all 100 books this book cites
- Microbial Contamination Control in the Pharmaceutical Industry (Drugs and the Pharmaceutical Sciences) by Luis Jimenez in Copyright
- Microbial Contamination Control in Parenteral Manufacturing (Drugs and the Pharmaceutical Sciences) by Kevin Williams in Front Matter
- New Drug Approval Process, Fourth Edition, Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) by Richard Guarino in Front Matter
- New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics (Drugs and the Pharmaceutical Sciences) by Chandrahas Sahajwalla in Front Matter
- The Pharmaceutical Regulatory Process (Drugs and the Pharmaceutical Sciences) by Ira R. Berry in Copyright
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