Drug development. (2019)

• Record Type: Book
• Further Information: Note: Editor, Charles E. Hamner.
• Other Names: Hamner, Charles E
• Contents: 1. Introduction Charles E. Hamner 2. Program Coordination and Management Charles E. Hamner 3. Project Cost Monitoring David E. Jones 4. Information Management Richard L. Chamberlain 5. Drug Design Alfred Burger 6. Approaches to Screening Compounds for Pharmacological Activity Alfred Burger 7. Biologics as Therapeutic Agents: Pitfalls and promises Michael Williams 8. Project Selection Factors in Pharmaceutical R & D Richard E. Faust 9. The Statistician in Pharmaceutical Development Walter B. Cummins and Gerald B. Hajian 10. Toxicology Ralph Fogleman 11. Pharmaceutical Product Development from Concept to Market Allen J. Polon 12. Notice of Claimed Investigation Exemption for a New Drug Joyce Williams 13. Biopharmaceutic and Pharmacokinetic Studies John H. Wood 14. Managing and Conducting Phase 1 and Phase 2 Studies John A. Owen, Jr 15. Conducting Phase 3 and Phase 4 Clinical Trials Carlos R. Ayers 16. Monitoring Clinical Studies Winston Liao 17. Preparing the New Drug Application Robert A. Pearlberg 18. Product Liability Issues in Drug Development William G. Pappas and Kenneth D. Sibley 19. Legal Aspects of Product Protection William G. Pappas and Kenneth D. Sibley 20. The Impact of Biotechnology on the Pharmaceutical Industry i21. To Start a Biotechnology Company i22. Global Consideration in the Development and Production of Pharmaceuticals J. David Tucker and James W. Parker
• Edition: Second edition
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615/.19; Pharmaceutical technology; Pharmaceutical industry -- United States; MEDICAL / Pharmacology; Pharmaceutical industry; Pharmaceutical technology; United States; Electronic books
• Languages: English
• ISBNs: 0429262396; 9780429262395; 9780429552991; 0429552998; 9780429561931; 0429561938; 9780429557460; 0429557469
• Notes: Note: Includes bibliographical references and index.
• 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.