Gender difference meta-analyses should be used more in NDAs, FDAer recommends.
GENDER DIFFERENCE META-ANALYSES IN NDAs RECOMMENDED BY FDAer Stella Machado, PhD, Quantitative Methods & Research Staff director, during the agency's "Gender Studies in Product Development Workshop" Nov. 7. Machado suggested "more use of meta-analysis to maximize the information gained on drug effects on both genders." However, she reminded the audience, "this whole area of meta-analysis requires creativity and thought."
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