This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Parkinson, C. Articles by Lumley, C. E Search for Related Content PubMed PubMed Citation Articles by Parkinson, C. Articles by Lumley, C. E Social Bookmarking                         What's this?

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

Centre for Medicines Research International, Woodmansterne Road, Carshalton, Surrey, SM5 4DS, UK

Kate E Thomas

Centre for Medicines Research International, Woodmansterne Road, Carshalton, Surrey, SM5 4DS, UK

Cyndy E Lumley

Centre for Medicines Research International, Woodmansterne Road, Carshalton, Surrey, SM5 4DS, UK

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.

Key Words: female reproductive toxicity • female fertility • embryo- fetal • peri- and post-natal • non-clinical testing strategy • inclusion of women • pharmaceuticals

Human & Experimental Toxicology, Vol. 16, No. 5, 239-246 (1997)
DOI: 10.1177/096032719701600501


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?