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4. Considerations for metabolite pharmacokinetic data in bioavailability/bioequivalence assessments. Overview of the recent trends. Srinivas NR Arzneimittelforschung; 2009; 59(4):155-65. PubMed ID: 19517891 [TBL] [Abstract][Full Text] [Related]
5. An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies. Kringle RO Pharm Res; 1994 Apr; 11(4):556-60. PubMed ID: 8058615 [TBL] [Abstract][Full Text] [Related]
6. Bioavailability and bioequivalence trials: statistics & pharmacokinetic principles. Rajaram L; Roy SK; Skerjanec A Stud Health Technol Inform; 2004; 103():159-79. PubMed ID: 15747918 [TBL] [Abstract][Full Text] [Related]
7. Bioavailability/bioequivalence of modified release drug delivery systems: which pharmacokinetic parameters to determine, single or multiple dose studies, pretests, conditions and other aspects. Ritschel WA Methods Find Exp Clin Pharmacol; 1992; 14(6):469-82. PubMed ID: 1469957 [No Abstract] [Full Text] [Related]
8. When are bioavailability studies required? A German proposal. Gleiter CH; Klotz U; Kuhlmann J; Blume H; Stanislaus F; Harder S; Paulus H; Poethko-Müller C; Holz-Slomczyk M J Clin Pharmacol; 1998 Oct; 38(10):904-11. PubMed ID: 9807970 [TBL] [Abstract][Full Text] [Related]
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11. [3rd International Regulatory Workshop on A to Z on bioequivalence, bioanalysis, dissolution and biosimilarity]. Acta Pharm Hung; 2012; 82(3):121-4. PubMed ID: 23230651 [No Abstract] [Full Text] [Related]
12. [Assessment of bioequivalence]. Aoyagi N Eisei Shikenjo Hokoku; 1996; (114):141-2. PubMed ID: 9037886 [TBL] [Abstract][Full Text] [Related]
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14. Bioavailability and bioequivalence: focus on physiological factors and variability. Karalis V; Macheras P; Van Peer A; Shah VP Pharm Res; 2008 Aug; 25(8):1956-62. PubMed ID: 18551249 [TBL] [Abstract][Full Text] [Related]
15. Japanese guidance on bioavailability and bioequivalence. Aoyagi N Eur J Drug Metab Pharmacokinet; 2000; 25(1):28-31. PubMed ID: 11032086 [TBL] [Abstract][Full Text] [Related]
16. Effect of Different Sampling Schedules on Results of Bioavailability and Bioequivalence Studies: Evaluation by Means of Monte Carlo Simulations. Kano EK; Chiann C; Fukuda K; Porta V Drug Res (Stuttg); 2017 Aug; 67(8):451-457. PubMed ID: 28561232 [TBL] [Abstract][Full Text] [Related]
17. Drug Product Selection--Part 2: Scientific basis of bioavailability and bioequivalence testing. Meyer MC Am Pharm; 1991 Aug; NS31(8):47-52. PubMed ID: 1927900 [No Abstract] [Full Text] [Related]