New Drug Approval Process
eBook - ePub

New Drug Approval Process

  1. 552 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

New Drug Approval Process

About this book

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.

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Information

Publisher
CRC Press
Year
2016
Print ISBN
9781420088496
Edition
5
eBook ISBN
9781040169827
Topic
Business
Subtopic
Government & Business
Index
Business

Table of contents

  1. Cover
  2. Half Title
  3. Title Page
  4. Copyright Page
  5. Dedication
  6. Preface
  7. Table of Contents
  8. Contributors
  9. Introduction
  10. 1 Drug Development Teams
  11. 2 FDA Approvable Indications and Other Considerations
  12. 3 Data Presentation for Global Submissions: Text and Tabular Exposition—CTD Format
  13. 4 Technology Change—Enabling Clinical Research and Drug Development Processes
  14. 5 Working with a Contract Research Organization (CRO)
  15. 6 Industry and FDA Liaison
  16. 7 Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
  17. 8 The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB)
  18. 9 New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats
  19. 10 Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
  20. 11 The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
  21. 12 The Biologic License Application
  22. 13 Chemistry, Manufacturing, and Control (ICH Quality Guidelines)
  23. 14 New Medical Device Approval Process in the United States
  24. 15 Orphan Drugs
  25. 16 Clinical Research Protocols
  26. 17 Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials
  27. 18 HIPAA: A New Requirement to the Clinical Study Process
  28. 19 Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting
  29. 20 Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions
  30. 21 CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors
  31. 22 Quality Assurance
  32. 23 Managing and Monitoring Clinical Trials
  33. 24 European CT Directive: Implementation and Update
  34. 25 Combination Products
  35. 26 The Current State of GXP in China
  36. Acronyms and Initialisms
  37. Index

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Yes, you can access New Drug Approval Process by Richard A. Guarino,Richard Guarino in PDF and/or ePUB format, as well as other popular books in Business & Government & Business. We have over 1.5 million books available in our catalogue for you to explore.