Fundamentals of biologicals regulation : vaccines and biotechnology medicines /: vaccines and biotechnology medicines. (2017)

• Record Type: Book
• Further Information: Note: Rebecca Sheets.
• Authors: Sheets, Rebecca
• Contents: Section I: Regulatory Process 1. Introduction 2. Discovery and Development of Biologicals 3. International Harmonization 4. Pre-IND Profess, Guidance from Regulators in Advance of a Clinical Trials Application 5. Clinical Trials Approvals and Investigational New Drug Applications 6. Marketing Authorization Processes 7. Special Regulatory Programs 8. Post-Marketing Changes to an Approved Application or Variations 9. Compliance and Inspections 10. Good "X" Practices Section II: Regulatory Science 11. Preclinical Safety and Toxicology 12. Preclinical Proof-of-Concept and Pharmacology, Animal Use Ethics 13. Genetically Modified Organisms and Institutional Biosafety Committees 14. Risk Assessments 15. Chemistry, Manufacturing, and Controls Information (CMC) and Process Validation 16. Analytics, Analytical Validation, Lot Release, and National Control Laboratories 17. Regulatory Aspects of Clinical Trials 18. Ethics of Clinical Trials and the Informed Consent Process 19. Institutional Review Board Processes (Ethics Committees) 20. Biosimilars 21. In Vitro Diagnostics 22. Regulatory Policy and Public Health Policy
• Publisher Details: Amsterdam : Academic Press
• Publication Date: 2017
• Extent: 1 online resource
• Subjects: 571.7; Biological control systems; Vaccines; Biotechnology
• Languages: English
• ISBNs: 9780128094433
• Related ISBNs: 9780128092903
• Notes: Note: Description based on CIP data; resource not viewed.
• 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.