New Drug Approval Process
eBook - PDF

New Drug Approval Process

  1. 552 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

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 harmonizationa step-by-step

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

Information

Publisher
CRC Press
Year
2016
Print ISBN
9781138044937
eBook ISBN
9781420088502
Edition
5
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Preface
  3. Contents
  4. PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT
  5. 1. Drug Development Teams
  6. 2. FDA Approvable Indications and Other Considerations
  7. 3. Data Presentation for Global Submissions: Text and Tabular Expositionā€”CTD Format
  8. 4. Technology Changeā€”Enabling Clinical Research and Drug Development Processes
  9. 5. Working with a Contract Research Organization (CRO)
  10. 6 Industry and FDA Liaison
  11. PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL
  12. 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology
  13. 8. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigatorā€™s Brochure (IB)
  14. 9. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats
  15. 10. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
  16. 11. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
  17. 12. The Biologic License Application
  18. 13. Chemistry, Manufacturing, and Control (ICH Quality Guidelines)
  19. 14. New Medical Device Approval Process in the United States
  20. 15. Orphan Drugs
  21. PART III DEVELOPING CLINICAL RESEARCH TRIALS
  22. 16. Clinical Research Protocols
  23. 17. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials
  24. 18. HIPAA: A New Requirement to the Clinical Study Pr
  25. 19. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, andReporting
  26. 20. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions
  27. PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP)
  28. 21. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, andMonitors
  29. 22. Quality Assurance
  30. 23. Managing and Monitoring Clinical Trials
  31. 24. European CT Directive: Implementation and Update
  32. PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS
  33. 25. Combination Products
  34. 26. The Current State of GXP in China
  35. Acronyms and Initialisms
  36. Index