New drug development : regulatory paradigms for clinical pharmacology and biopharmaceutics /: regulatory paradigms for clinical pharmacology and biopharmaceutics. (©2004)

• Record Type: Book
• Further Information: Note: Edited by Chandrahas G. Sahajwalla.
• Other Names: Sahajwalla, Chandrahas G
• Contents: Book Cover; Half-Title; Title; Copyright; Foreword; Preface; Contents; Contributors; 1 Introduction to Drug Development and Regulatory Decision-Making; 2 Evolution of Drug Development and its Regulatory Process; 3 Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application; 4 New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics; 5 In-vitro Drug Metabolism Studies During Development of New Drugs; 6 Drug Transporters; 7 Principles, Issues, and Applications of Interspecies Scaling; 8 Analytical Method Validation.
• Publisher Details: New York : Marcel Dekker
• Publication Date: 2004
• Copyright Date: 2004
• Extent: 1 online resource (xix, 596 pages), illustrations
• Subjects: 615.19; Drug development; Drugs -- Testing -- Standards; Drug Approval; Drug Evaluation, Preclinical -- standards; Biopharmaceutics -- standards; Pharmaceutical Preparations -- analysis; Pharmaceutical Preparations -- standards; Pharmacology, Clinical; Technology, Pharmaceutical -- standards; Drug approval; Drug evaluation, Preclinical -- Standards -- United States; Biopharmaceutics -- Standards -- United States; Pharmaceutical preparations -- Analysis; Pharmaceutical preparations -- Standards -- United States; Pharmacology, Clinical; Technology, Pharmaceutical -- Standards -- United States; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drug development; Drugs -- Testing -- Standards; United States; Electronic books
• Languages: English
• ISBNs: 9780203026427; 9780824754655; 0824754654
• Related ISBNs: 020302642X; 0824754654
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.