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4. The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company. Hauschke D; Steinijans VW Stat Med; 2000 Oct; 19(20):2769-74. PubMed ID: 11033574 [TBL] [Abstract][Full Text] [Related]
9. Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group. Hauck WW; Chen ML; Hyslop T; Patnaik R; Schuirmann D; Williams R Int J Clin Pharmacol Ther; 1996 Dec; 34(12):535-41. PubMed ID: 8996848 [TBL] [Abstract][Full Text] [Related]
10. The bioequivalence of highly variable drugs and drug products. Midha KK; Rawson MJ; Hubbard JW Int J Clin Pharmacol Ther; 2005 Oct; 43(10):485-98. PubMed ID: 16240706 [TBL] [Abstract][Full Text] [Related]
12. Drug bioequivalence. Recommendations from the Drug Bioequivalence Study Panel to the Office of Technology Assessment, Congress of the United States. J Pharmacokinet Biopharm; 1974 Oct; 2(5):433-66. PubMed ID: 4452945 [No Abstract] [Full Text] [Related]
13. The basis for individual bioequivalence. FDA Population and Individual Bioequivalence Working Group. Williams RL; Patnaik RN; Chen ML Eur J Drug Metab Pharmacokinet; 2000; 25(1):13-7. PubMed ID: 11032083 [No Abstract] [Full Text] [Related]
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16. Requirements for submission of bioequivalence data; final rule. Final rule. Food and Drug Administration, HHS Fed Regist; 2009 Jan; 74(11):2849-62. PubMed ID: 19385107 [TBL] [Abstract][Full Text] [Related]
17. Bioequivalence: the regulatory career of a pharmaceutical concept. Carpenter D; Tobbell DA Bull Hist Med; 2011; 85(1):93-131. PubMed ID: 21551918 [TBL] [Abstract][Full Text] [Related]