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Supporting Marketing Applications

  • Shayne C. GadEmail author
Chapter
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Abstract

Attrition of the therapeutic candidates getting to this point is quite high with perhaps only one of every 200 compounds designated as candidates proceeding beyond Phase 1. While there may well be studies, which were desirable before but deferred (CYP inhibition and induction, identification of major metabolites, abuse liability potential, and such).

Keywords

Marketing Approval Marketing Application Inactive Ingredient Repeat Dose Study Repeat Dose Toxicity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. ICH (1994) S3A Note for Guidance on Toxicokinetics: The Assessment of Systematic Exposure in Toxicity StudiesGoogle Scholar
  2. ICH (1995) S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsGoogle Scholar
  3. ICH (1997) S6 Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsGoogle Scholar
  4. ICH (2000) S7A Safety Pharmacology Studies for Human PharmaceuticalsGoogle Scholar
  5. ICH (2005) S5(R2) Detection of Toxicity to Reproduction for Medical Products & Toxicity to Male FertilityGoogle Scholar
  6. ICH (2008) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsGoogle Scholar
  7. IHC (2008) S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human UsGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Gad Consulting ServicesCaryUSA

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