Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

(2022) Nikunjkumar Patel et al.   CPT-Pharmacometrics & Systems Pharmacology

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

(2020) Sam G. Raney et al.   JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

(2020) Sumit Arora et al.   MOLECULAR PHARMACEUTICS

Physiologically Based Pharmacokinetic Modeling of Transdermal Selegiline and Its Metabolites for the Evaluation of Disposition Differences between Healthy and Special Populations

(2020) Santosh Kumar Puttrevu et al.   Pharmaceutics

Innovation for Generic Drugs: Science and Research under GDUFA

(2019) Robert A. Lionberger   CLINICAL PHARMACOLOGY & THERAPEUTICS

Evaluating the Bioequivalence of Metronidazole Tablets and Analyzing the Effect of in Vitro Dissolution on in Vivo Absorption Based on PBPK Modeling

(2019) Shuqi Zhang et al.   DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Topical bio(in)equivalence of metronidazole formulations in vivo

(2018) Thalita Pedon de Araujo et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

How Predictable Are Human Stratum Corneum Lipid/Water Partition Coefficients? Assessment and Useful Correlations for Dermal Absorption

(2018) Johannes M. Nitsche et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Determining the Effect of pH on the Partitioning of Neutral, Cationic and Anionic Chemicals to Artificial Sebum: New Physicochemical Insight and QSPR Model

(2018) Senpei Yang et al.   PHARMACEUTICAL RESEARCH

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

(2018) Manuela Grimstein et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug

(2017) Shriram M. Pathak et al.   MOLECULAR PHARMACEUTICS

On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl

(2017) Soo Hyeon Shin et al.   PHARMACEUTICAL RESEARCH

Mechanistic Evaluation of Hydration Effects on the Human Epidermal Permeation of Salicylate Esters

(2016) Shereen Yousef et al.   AAPS Journal

Changes in Retail Prices of Prescription Dermatologic Drugs From 2009 to 2015

(2016) Miranda E. Rosenberg et al.   JAMA Dermatology

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

(2015) Sam G. Raney et al.   CLINICAL PHARMACOKINETICS

Identifiability of PBPK models with applications to dimethylarsinic acid exposure

(2015) Ramon I. Garcia et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

In Silico Prediction of Percutaneous Absorption and Disposition Kinetics of Chemicals

(2014) Longjian Chen et al.   PHARMACEUTICAL RESEARCH

Metronidazole and Hydroxymetronidazole Central Nervous System Distribution: 2. Cerebrospinal Fluid Concentration Measurements in Patients with External Ventricular Drain

(2013) Denis Frasca et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

(2012) Rong-Kun Chang et al.   AAPS Journal

Improved input parameters for diffusion models of skin absorption

(2012) Steffi Hansen et al.   ADVANCED DRUG DELIVERY REVIEWS

Physiologically Based Pharmacokinetics Joined With In Vitro–In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

(2012) A Rostami-Hodjegan   CLINICAL PHARMACOLOGY & THERAPEUTICS

Mathematical models of skin permeability: An overview

(2011) Samir Mitragotri et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Percutaneous Absorption in Man: In vitro-in vivo Correlation

(2011) P.A. Lehman et al.   SKIN PHARMACOLOGY AND PHYSIOLOGY

Use of Excised Human Skin to Assess the Bioequivalence of Topical Products

(2009) T.J. Franz et al.   SKIN PHARMACOLOGY AND PHYSIOLOGY