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9 Apr 2009 Reproductive toxicity testing for pharmaceuticals under ICH. A proposed revision of the ICH M3 guideline addresses contradictions
11 Jun 2009 This guideline has been developed by the appropriate ICH Expert .. pharmacokinetic studies, reproduction toxicity studies, genotoxicity
29 Aug 2017 ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction Other considerations for reproductive toxicity studies .
The aims of reproduction toxicology studies. 0 ICH Guidelines. 0 The basic reproductive cycle. 0 How certain drugs can affect the cycle. In this presentation
B. Types of Reproductive and Developmental Toxicity .. See the following International Conference on Harmonisation (ICH) of Systemic Exposure in Toxicity Studies; S5(R2) Detection of Toxicity to Reproduction for Medicinal Products &.
11 Oct 2012 Reproductive toxicology in preclinical safety tested in standard pre-clinical studies . Studies performed to ICH guidelines should be
24 Jun 1993 Parent Guideline: Detection of Toxicity to Reproduction for . The aim of reproduction toxicity studies is to reveal any effect of one or more.
This is a revision of the ICH guidance “M3 Nonclinical Safety Studies for the pharmacokinetic studies, reproduction toxicity studies, genotoxicity studies and,
Finalised Guideline: June 2011. Description : An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential.
22 Sep 1994 Reproduction for Medicinal. Products. ICH-S5A. September 1994 . The aim of reproduction toxicity studies is to reveal any effect of one.
     

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