Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV.
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AAPS J. 2005 Oct 7;7(3):E503-12. doi: 10.1208/aapsj070351.
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PMID: 16353928
Free PMC article.
Review.
Of the 14 reviews that were pivotal to approval related decisions, 5 identified the need for additional trials, whereas 6 reduced the burden of conducting additional trials. Collaboration among the FDA clinical pharmacology, medical, and statistical reviewers and ef …
Of the 14 reviews that were pivotal to approval related decisions, 5 identified the need for additional trials, whereas 6 reduced the …