Skip to main content

Supporting Marketing Applications

  • Chapter
  • First Online:
  • 1392 Accesses

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).

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  • ICH (1994) S3A Note for Guidance on Toxicokinetics: The Assessment of Systematic Exposure in Toxicity Studies

    Google Scholar 

  • ICH (1995) S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

    Google Scholar 

  • ICH (1997) S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

    Google Scholar 

  • ICH (2000) S7A Safety Pharmacology Studies for Human Pharmaceuticals

    Google Scholar 

  • ICH (2005) S5(R2) Detection of Toxicity to Reproduction for Medical Products & Toxicity to Male Fertility

    Google Scholar 

  • ICH (2008) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

    Google Scholar 

  • IHC (2008) S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Us

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Shayne C. Gad .

Rights and permissions

Reprints and permissions

Copyright information

© 2011 Springer Science+Business Media, LLC

About this chapter

Cite this chapter

Gad, S.C. (2011). Supporting Marketing Applications. In: Safety Evaluation of Pharmaceuticals and Medical Devices. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-7449-5_5

Download citation

Publish with us

Policies and ethics