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ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

June 2011

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ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

June 2011
click to view Guidance Document
In this Technical Brief:
Product Type(s):

  • Pharmaceuticals
Topic(s):

  • Preclinical Safety
  • Regulatory Issues
Region(s):

  • United States

Full Info:


Resource Type:

Guidance Document

Citation:

European Medicines Agency (2013)

Authors:

European Medicines Agency

Product type(s):

  • ARVs
  • Hormonal
  • Microbicide
  • MPTs

Topic(s):

  • MPTs
  • Development
  • Regulatory

Region(s)

  • United States

URL of resource:

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals-step-5_en.pdf

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