New drug approval process. (©2009)

• Record Type: Book
• Further Information: Note: Edited by Richard A. Guarino.
• Other Names: Guarino, Richard A, 1935-
• Contents: Front Cover; Preface; Contents; PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT; 1. Drug Development Teams; 2. FDA Approvable Indications and Other Considerations; 3. Data Presentation for Global Submissions: Text and Tabular Exposition -- CTD Format; 4. Technology Change -- Enabling Clinical Research and Drug Development Processes; 5. Working with a Contract Research Organization (CRO); 6 Industry and FDA Liaison; PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL; 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology.
• Edition: 5th ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2009
• Copyright Date: 2009
• Extent: 1 online resource (xviii, 529 pages), illustrations
• Subjects: 615/.1; Drug approval -- United States; Drugs -- Testing -- Standards; Drugs -- Testing -- Government policy -- United States; New products -- Government policy -- United States; Drug Evaluation -- standards; Clinical Trials as Topic -- standards; Drug Approval; Drug approval -- United States; Drugs -- Testing -- Government policy -- United States; Drugs -- Testing -- Standards; New products -- Government policy -- United States; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drug approval; Drugs -- Testing -- Government policy; Drugs -- Testing -- Standards; New products -- Government policy; United States; United States; Electronic books
• Languages: English
• ISBNs: 9781420088502; 1420088505
• 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.