The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to show bioequivalence between different formulations or generic companies between generic drugs and brand drugs before approval. A recent FDA guidance on bioequivalence proposes criteria for assessment of population bioequivalence...
LC-MS/MS determination of tacrolimus in human blood and application in its bioequivalence study. Chin J Pharm Anal 2009; 29: 237–42. Google Scholar Osserman KE, Genkins G . Studies in myasthenia gravis: review of a twenty-year experience in over 1200 patients. Mt Sinai J Med 1971; 38...
Data were retrospectively analyzed from a single-dose, parallel-group bioequivalence study in healthy adults who received a single 40-mg SC injection of ABP 501 or adalimumab RP. Modeling was performed by using NONMEM 7.2. The impact of ADAs on PK similarity was assessed from population model-ba...
In all, 28 data sets from 20 replicate crossover bioequivalence studies have been analyzed (n = 12芒聙聯96) using the statistical methodology in the most recent FDA draft guidance. The results are presented below.Review of the database reveals many interesting features, most notably the lack ...
In a recent FDA guidance on bioequivalence, new criteria were proposed for assessment of population and individual bioequivalence. In this article, computer simulation is used to compare a modified large sample (MLS) upper bound for the population bioequivalence ratio with the bootstrap upper bound ...
FDA 1997 In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches--Draft Guidance for Industry (Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research (CDER))F.D.A. (1997) Draft .Guidance for industry (in-vivo Bioequivalence studie...
The Food and Drug Administration (FDA) issued a second-draft guidance in August 1999 on the subject of in vivo bioequivalence, which is based on the concepts of individual and population bioequivalence (IBE and PBE, respectively). The intention of this guidance is to replace the 1992 guidance ...
BioequivalenceTopical corticosteroidsExploratory data analysisPopulation dynamic analysisHill modelA guidance of the Food and Drug Administration (FDA) recommends that the pharmacodynamic (PD) equivalence of topical corticosteroid preparations be demonstrated by a two-step procedure. A pilot study would ...