A randomized, multiple-dose parallel study to compare the pharmacokinetic parameters of synthetic conjugated estrogens, A, administered as oral tablet or vaginal cream.

Autor: Bhamra RK, Margolis MB, Liu JH, Hendy CH, Jenkins RG, Diliberti CE, Bhamra, Rupinder K, Margolis, Marya B, Liu, James H, Hendy, Christopher H, Jenkins, Rand G, DiLiberti, Charles E

Publikováno v: Menopause (10723714); 2011 Apr, Vol. 18 Issue 4, p393-399, 7p

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.

Autor: Lee J; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Gong Y; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Bhoopathy S; Absorption Systems, Exton, Pennsylvania, USA., DiLiberti CE; Montclair Bioequivalence Services, LLC, Upper Montclair, New Jersey, USA., Hooker AC; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Rostami-Hodjegan A; Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK.; Certara, Princeton, New Jersey, USA., Schmidt S; Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics, University of Florida, Orlando, Florida, USA., Suarez-Sharp S; Simulations Plus, Inc, Lancaster, California, USA., Lukacova V; Simulations Plus, Inc, Lancaster, California, USA., Fang L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Nov; Vol. 110 (5), pp. 1190-1195. Date of Electronic Publication: 2020 Dec 29.

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Autor: Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Kim MJ; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Li Z; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., DiLiberti CE; Montclair Bioequivalence Services, LLC, Montclair, New Jersey, USA., Au J; Optimum Therapeutics LLC, Carlsbad, California, USA., Hooker A; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Ducharme MP; Learn and Confirm Inc., Bois Franc, St-Laurent, Canada., Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2018 Jul; Vol. 104 (1), pp. 27-30. Date of Electronic Publication: 2018 Mar 30.

Additional results for 'Sequential design approaches for bioequivalence studies with crossover designs'.

Autor: Montague TH; GlaxoSmithKline, Inc., King of Prussia, PA, USA., Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ

Publikováno v: Pharmaceutical statistics [Pharm Stat] 2012 Jan-Feb; Vol. 11 (1), pp. 8-13. Date of Electronic Publication: 2011 Feb 10.

Sequential design approaches for bioequivalence studies with crossover designs.

Autor: Potvin D; Theratechnologies Inc., Montréal, Québec, Canada., DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA

Publikováno v: Pharmaceutical statistics [Pharm Stat] 2008 Oct-Dec; Vol. 7 (4), pp. 245-62.