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To allow the continued participation of women enrolled in pre‐licensure clinical trials who become pregnant, and to potentially enrol pregnant women in clinical trials, non‐clinical developmental and reproductive toxicology studies… Click to show full abstract
To allow the continued participation of women enrolled in pre‐licensure clinical trials who become pregnant, and to potentially enrol pregnant women in clinical trials, non‐clinical developmental and reproductive toxicology studies (DART) are essential. Generally during pharmaceutical development, DART studies are conducted late during clinical development, leading to the exclusion of pregnant women from enrolment and withdrawal of women becoming pregnant during pre‐licensure trials.
Keywords:
clinical considerations;
clinical trials;
pre licensure;
licensure clinical;
pregnant women;
non clinical
Journal Title: Journal of the International AIDS Society
Year Published: 2022
Link to full text (if available)
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Journal Title: Journal of the International AIDS Society
Year Published: 2022
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!