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

Development and Qualification of a Physiologically Based Pharmacokinetic Model of Finasteride and Minoxidil Following Scalp Application

(2021) Arpar Ngampanya et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

(2019) Tycho Heimbach et al.   AAPS Journal

Skin metabolism phase I and phase II enzymes in native and reconstructed human skin: a short review

(2019) Siamaque Kazem et al.   DRUG DISCOVERY TODAY

Skin Metabolism: Relevance of Skin Enzymes for Rational Drug Design

(2019) Sung Min Pyo et al.   SKIN PHARMACOLOGY AND PHYSIOLOGY

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen

(2019) Ioannis Loisios-Konstantinidis et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

(2019) Mark McAllister et al.   Pharmaceutics

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

(2018) Mohamad Shebley et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Compartmental modeling of skin transport

(2018) A.A. Amarah et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Past, present and future of bioequivalence: Improving assessment and extrapolation of therapeutic equivalence for oral drug products.

(2018) Rodrigo Cristofoletti et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Application of Physiologically-Based Pharmacokinetic Modeling to Predict Pharmacokinetics in Healthy Japanese Subjects

(2018) Yuki Matsumoto et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Generating Model Integrated Evidence for Generic Drug Development and Assessment

(2018) Liang Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Biopharmaceutic IVIVE – Mechanistic Modelling of Single- and Two-Phase In Vitro Experiments to Obtain Drug-Specific Parameters for Incorporation into PBPK Models

(2018) Shriram M. Pathak et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

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

(2017) Kosuke Doki et al.   EUROPEAN 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

Epidermal cell turnover across tight junctions based on Kelvin's tetrakaidecahedron cell shape

(2016) Mariko Yokouchi et al.   eLife

Predicting Abraham model solvent coefficients

(2015) Jean-Claude Bradley et al.   Chemistry Central Journal

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

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

Animal models for percutaneous absorption

(2014) Eui Chang Jung et al.   JOURNAL OF APPLIED TOXICOLOGY

In Silico Prediction of Percutaneous Absorption and Disposition Kinetics of Chemicals

(2014) Longjian Chen et al.   PHARMACEUTICAL RESEARCH

Percutaneous absorption and distribution of organophosphates (chlorpyrifos and dichlorvos) following dermal exposure and decontamination scenarios using in vitro human skin model

(2014) C.A. Moore et al.   TOXICOLOGY LETTERS

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

(2013) Shiew-Mei Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Improved input parameters for diffusion models of skin absorption

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

Mathematical and pharmacokinetic modelling of epidermal and dermal transport processes

(2012) Yuri G. Anissimov et al.   ADVANCED DRUG DELIVERY REVIEWS

Dermal Clearance Model for Epidermal Bioavailability Calculations

(2012) Rania Ibrahim et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Measuring the stratum corneum reservoir: Desorption kinetics from keratin

(2012) Salem Seif et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Prediction of Concentration–Time Profile and its Inter-Individual Variability following the Dermal Drug Absorption

(2012) Sebastian Polak et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Convective transport of highly plasma protein bound drugs facilitates direct penetration into deep tissues after topical application

(2011) Yuri Dancik et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Lamellar Lipid Organization and Ceramide Composition in the Stratum Corneum of Patients with Atopic Eczema

(2011) Michelle Janssens et al.   JOURNAL OF INVESTIGATIVE DERMATOLOGY

Finite difference schemes for multilayer diffusion

(2011) R.I. Hickson et al.   MATHEMATICAL AND COMPUTER MODELLING

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

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Efficacy of skin wash on dermal absorption: an in vitro study on four model compounds of varying solubility

(2010) Jesper Bo Nielsen   INTERNATIONAL ARCHIVES OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

(2009) Masoud Jamei et al.   Drug Metabolism and Pharmacokinetics

Physiologically based mechanistic modelling to predict complex drug–drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut—The effect of diltiazem on the time-course of exposure to triazolam

(2009) Karen Rowland Yeo et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

(2008) Robert A. Lionberger   AAPS Journal

The effect of irritant dermatitis on cutaneous bioavailability of a metronidazole formulation, investigated by microdialysis and dermatopharmacokinetic method

(2008) Patricia García Ortiz et al.   CONTACT DERMATITIS

Investigation of drug partition property in artificial sebum

(2007) Satyanarayana Valiveti et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Partitioning, diffusivity and clearance of skin permeants in mammalian dermis

(2007) Kosmas Kretsos et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS