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E-book: New Drug Approval Process

Edited by (Oxford Pharmaceutical Resources, Totowa, New Jersey, USA), Edited by
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The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:













advances in international regulatory requirements, including ICH guidelines and harmonization a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development
Preface ix
Contributors xv
Introduction xvii
PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT
1. Drug Development Teams
1
Duane B. Lakings
2. FDA Approvable Indications and Other Considerations
14
Peter Levitch
3. Data Presentation for Global Submissions: Text and Tabular Exposition—CTD Format
23
Patricia Blaine
4. Technology Change—Enabling Clinical Research and Drug Development Processes
29
Brian J. Chadwick
5. Working with a Contract Research Organization (CRO)
42
Duane B. Lakings
6. Industry and FDA Liaison
56
Richard A. Guarino
PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL
7. Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
75
Duane B. Lakings
8. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB)
110
Richard A. Guarino
9. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats
145
Richard A. Guarino
10. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
166
Richard A. Guarino
11. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
180
Duane B. Lakings
12. The Biologic License Application
219
Albert A. Ghignone
13. Chemistry, Manufacturing, and Control (ICH Quality Guidelines)
241
John R. Rapoza and Evan B. Siegel
14. New Medical Device Approval Process in the United States
266
Max Sherman
15. Orphan Drugs
287
Richard A. Guarino
PART III DEVELOPING CLINICAL RESEARCH TRIALS
16. Clinical Research Protocols
301
Richard A. Guarino
17. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials
325
Rochelle L. Goodson
18. HIPAA: A New Requirement to the Clinical Study Process
341
Glenn D. Watt, Earl W. Hulihan, and Richard A. Guarino
19. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting
352
Richard A. Guarino
20. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions
376
Mark Bradshaw
PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP)
21. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors
393
Richard A. Guarino
22. Quality Assurance
402
Helena M. Van den Dungen, Earl W. Hulihan, and Richard A. Guarino
23. Managing and Monitoring Clinical Trials
411
Andrea Proccacino
24. European CT Directive: Implementation and Update
427
Kent Hill and Richard A. Guarino
PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS
25. Combination Products
439
Evan B. Siegel
26. The Current State of GXP in China
461
Earl W. Hulihan, Daniel Liu, Cai Cao, and Qingshan Zheng
Acronyms and Initialisms 509
Index 525
Richard A. Guarino, Richard Guarino
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