Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

scientific article published on 11 December 2015

Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA. is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1016/J.TIPS.2015.11.005
P8608Fatcat IDrelease_dx7uqqjdxzfnpprqjcvj4n7mby
P698PubMed publication ID26687297

P50authorTod CoopermanQ61796717
Erin R. FoxQ91934153
P2093author name stringRoger Bate
Harry M Lever
Dinesh Thakur
Aparna Mathur
Joe Graedon
Preston Mason
P433issue3
P304page(s)184-191
P577publication date2015-12-12
P1433published inTrends in Pharmacological SciencesQ2451474
P1476titleGenerics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA
P478volume37

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cites work (P2860)
Q90521688Barriers to Oncology Biosimilars Uptake in the United States
Q93263281Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial
Q37334533Evaluation of pharmaceutical concerns in Germany: frequency and potential reasons
Q49720626Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges
Q94582722Stereoselective steady-state disposition and bioequivalence of brand and generic bupropion in adults
Q37322523Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies.

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