Developmental and reproductive toxicity testing – The next generation

2017 ◽  
Vol 72 ◽  
pp. 19
Author(s):  
Manon Beekhuijzen
Keyword(s):  
Reproductive Toxicity ◽  
Toxicity Testing ◽  
Next Generation

Food and drug administration guidelines for reproductive toxicity testing

1988 ◽  
Vol 2 (3-4) ◽  
pp. 291-293 ◽  
Author(s):  
Krishan L. Raheja ◽  
Alexander Jordan ◽  
Jean L. Fourcroy
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Reproductive Toxicity ◽  
Toxicity Testing

Proceedings of the Workshop on One-vs Two-Generation Reproductive Effects Studies

1988 ◽  
Vol 7 (7) ◽  
pp. 911-925 ◽  
Author(s):  
Elaine Z. Francis ◽  
Gary L. Kimmel
Keyword(s):  
Reproductive Toxicity ◽  
Toxicity Testing ◽  
Critical Factor ◽  
Test Methods ◽  
Toxic Substances ◽  
Test Protocol ◽  
Reproductive Effects ◽  
Toxicity Potential ◽  
Adequate Evaluation ◽  
Reproductive Toxicants

The Workshop on One-vs Two-Generation Reproductive Effects Studies was held on October 21-22, 1987. It was organized by the USEPA's Office of Pesticides and Toxic Substances and Office of Research and Development and was supported by the Agency's Risk Assessment Forum. The purpose of the workshop was to address the central question: Is a single-generation reproductive effects study sufficient to assess the reproductive toxicity potential of chemicals that do not bioaccumulate? In response to this question, the panel of nine participants concluded that, by itself, a one-generation reproductive effects study is insufficient to identify all potential reproductive toxicants and that a two-generation study is needed for an adequate assessment. The panel did not support placing much importance on bioaccumulation as related to reproductive toxicity testing mainly because it is not the only critical factor that may account for effects in a second generation but not in the first. In studying broader issues, the panel accomplished several goals that hopefully may serve to direct future development in reproductive toxicity testing: (1) the purpose of a reproductive effects study was defined, (2) a minimal set of end points necessary for adequate evaluation of reproductive toxicity was determined, (3) some alternative reproductive effects test methods were recommended, (4) greater flexibility in choosing a test protocol on a case by case basis was encouraged, and (5) areas that need further research were identified.

Reproductive toxicity testing of pharmaceutical compounds to support the inclusion of women in clinical trials

1997 ◽  
Vol 16 (5) ◽  
pp. 239-246 ◽  
Author(s):  
Chris Parkinson ◽  
Kate E Thomas ◽  
Cyndy E Lumley
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Animal Studies ◽  
Clinical Investigation ◽  
Reproductive Toxicity ◽  
Toxicity Testing ◽  
Toxicity Tests ◽  
Toxicity Studies ◽  
Important Concern ◽  
The Usa

1 The potential for toxicity to reproduction and the developing fetus is an important concern requiring attention during the development of new medicines. However, there are differences in the opinions of the regulatory authorities in Europe, Japan and the USA regarding the nature and amount of data from reproductive toxicity tests that should be available at the various stages of clinical development. 2 Forty-one companies or their subsidiaries from Eur ope, Japan and the USA provided data for a ques tionnaire-based study, carried out in 1994, to ascertain the practices of pharmaceutical companies and their views on an ideal approach to the timing of reproduc tion and development toxicity studies in relation to clinical investigation. 3 Differences were identified in the stage of drug development at which animal studies were completed, the sequence of completion of specific studies, and the extent of reproduction testing completed to support the inclusion of women in clinical trials. 4 A harmonised, but flexible, guideline, encompassing the timing of reproductive toxicity studies in relation to clinical trials, would permit better integration between clinical and non-clinical studies in an international drug development programme.

Developmental toxicity associated with receptor tyrosine kinase Ret inhibition in reproductive toxicity testing

2009 ◽  
Vol 85 (2) ◽  
pp. 130-136 ◽  
Author(s):  
George R. Clemens ◽  
Raymond E. Schroeder ◽  
Steven H. Magness ◽  
Elizabeth V. Weaver ◽  
Joseph W. Lech ◽  
...  
Keyword(s):  
Tyrosine Kinase ◽  
Receptor Tyrosine Kinase ◽  
Developmental Toxicity ◽  
Reproductive Toxicity ◽  
Toxicity Testing
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