This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials · furnishes effective approaches for preclinical drug discovery · addresses the function of the clinical trials materials manager · covers the design of clinical protocols in developing a new chemical entity (NCE) · explains the importance of bioequivalence between clinical trials materials and final products · demonstrates rapid, reliable processes for clinical evaluation · discusses the interaction between clinical research, manufacturing, and packaging · reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world · and much more!
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Inside This Book
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First Sentence:
The emergence of the clinical trials manager as a truly important linchpin in the drug development team has not occurred by accident. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
clinical supplies manager, blinded comparator, preclinical pharmaceutics, blinded supplies, positive control drug, bioequivalency tests, manufacturing clinical supplies, clinical trial supplies, clinical packaging, development bioequivalence, clinical supply preparation, blinded clinical studies, manufacturing campaign, comparator product, clinical trial materials, clinical trials materials, medication card, investigational medicinal products, blister strips, bioavailability testing, clinical manufacturing, comparator drug, clinical batches, investigational products, blinding techniques Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Pharm Sci, New York, Investigational New Drug, United Kingdom, Pharm Technol, Pharm Res, International Conference, Code of Federal Regulations, Drug Dev Ind Pharm, Good Clinical Practice, Marcel Dekker, Product Import, Therapeutic Goods Administration, General Comments, Drug Inf, Drug Master File, European Community, European Union, Pharm Pharmacol, Usage Guidelines, Appl Clin Trials, Date Requested, Hosp Pharm, New Jersey New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
The emergence of the clinical trials manager as a truly important linchpin in the drug development team has not occurred by accident. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
clinical supplies manager, blinded comparator, preclinical pharmaceutics, blinded supplies, positive control drug, bioequivalency tests, manufacturing clinical supplies, clinical trial supplies, clinical packaging, development bioequivalence, clinical supply preparation, blinded clinical studies, manufacturing campaign, comparator product, clinical trial materials, clinical trials materials, medication card, investigational medicinal products, blister strips, bioavailability testing, clinical manufacturing, comparator drug, clinical batches, investigational products, blinding techniques Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Pharm Sci, New York, Investigational New Drug, United Kingdom, Pharm Technol, Pharm Res, International Conference, Code of Federal Regulations, Drug Dev Ind Pharm, Good Clinical Practice, Marcel Dekker, Product Import, Therapeutic Goods Administration, General Comments, Drug Inf, Drug Master File, European Community, European Union, Pharm Pharmacol, Usage Guidelines, Appl Clin Trials, Date Requested, Hosp Pharm, New Jersey 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 70
books:
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- 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)
- Public Finance by J. Richard Aronson on page 191, page 253, and page 257
- Modern Pharmaceutics by Gilbert S. Banker in Front Matter (1), Front Matter (2), and Front Matter (3)
- Novel Drug Delivery Systems (Drugs and the Pharmaceutical Sciences) by Yie Chien in Front Matter (1), and Front Matter (2)
- Drug Stability: Principles and Practices (Drugs and the Pharmaceutical Sciences) by Jens T. Carstensen in Front Matter (1), and Front Matter (2)
See all 70 books this book cites
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