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The following message was posted to: PharmPK
Dear Colleagues,
Normally for phase I studies include male subjects
only. I would like to know under what conditions
(excluding terminal diseases and female specific
indications) inclusion of female subjects are
justified or required (e.g., preclinical tox data
suggest females are more sensitive?)
Rostam
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The following message was posted to: PharmPK
Use of female subjects in Phase 1 trials need not be limited to
indications that are specific to women; such use could even be
appropriate for indications that have higher incidence in women. For
example, I am aware of Phase 1 trials of agents to be used for treatment
of osteoporosis in which post-menopausal women were included. Although
osteoporosis can affect both men and women, it is substantially more
frequent in women.
Thomas L. Tarnowski, Ph. D.
Project Team Leader
Dept. Head, Drug Metabolism and Pharmacokinetics
Roche Palo Alto
3431 Hillview Avenue, Palo Alto, CA 94304
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