4.3 Review

Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Editorial Material Dermatology

A new paradigm for topical generic drug products: Impact on therapeutic access

Sam G. Raney et al.

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY (2020)

Article Pharmacology & Pharmacy

Generating Model Integrated Evidence for Generic Drug Development and Assessment

Liang Zhao et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)

Article Pharmacology & Pharmacy

Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

Robert A. Lionberger

CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)

Article Pharmacology & Pharmacy

Physiologically based absorption modeling to predict bioequivalence of controlled release and immediate release oral products

Amitava Mitra et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2019)

Article Pharmacology & Pharmacy

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria

Kosuke Doki et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2017)

Review Rheumatology

Synovitis in osteoarthritis: current understanding with therapeutic implications

Alexander Mathiessen et al.

ARTHRITIS RESEARCH & THERAPY (2017)

Article Rheumatology

Synovial tissue volume: a treatment target in knee osteoarthritis (OA)

Terence W. O'Neill et al.

ANNALS OF THE RHEUMATIC DISEASES (2016)

Review Pharmacology & Pharmacy

Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products

Sam G. Raney et al.

CLINICAL PHARMACOKINETICS (2015)

Review Chemistry, Medicinal

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

Shiew-Mei Huang et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2013)

Article Chemistry, Medicinal

Prediction of Concentration-Time Profile and Its Inter-Individual Variability Following the Dermal Drug Absorption

Sebastian Polak et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2012)

Article Pharmacology & Pharmacy

A new topical formulation enhances relative diclofenac bioavailability in healthy male subjects

Martin Brunner et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2011)

Article Pharmacology & Pharmacy

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

P. Zhao et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)

Review Pharmacology & Pharmacy

FDA critical path initiatives: Opportunities for generic drug development

Robert A. Lionberger

AAPS JOURNAL (2008)

Article Orthopedics

Measurement of synovial fluid volume using urea

V. B. Kraus et al.

OSTEOARTHRITIS AND CARTILAGE (2007)

Article Pharmacology & Pharmacy

Favourable dermal penetration of diclofenac after administration to the skin using a novel spray gel formulation

M Brunner et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2005)

Article Pharmacology & Pharmacy

Application of cutaneous microdialysis to evaluate metronidazole and its main metabolite concentrations in the skin after a single oral dose

S Bielecka-Grzela et al.

JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS (2003)