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).
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ICH (1994) S3A Note for Guidance on Toxicokinetics: The Assessment of Systematic Exposure in Toxicity Studies
ICH (1995) S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
ICH (1997) S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH (2000) S7A Safety Pharmacology Studies for Human Pharmaceuticals
ICH (2005) S5(R2) Detection of Toxicity to Reproduction for Medical Products & Toxicity to Male Fertility
ICH (2008) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
IHC (2008) S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Us
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© 2011 Springer Science+Business Media, LLC
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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
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DOI: https://doi.org/10.1007/978-1-4419-7449-5_5
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