Andrew Babiskin

Affiliations

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Andrew.Babiskin@fda.hhs.gov.

Publications (30)

Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development.

The AAPS journal

Avec: Maxime Le Merdy , Ming-Liang Tan , Andrew Babiskin , Liang Zhao

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.

Journal of pharmaceutical sciences

Avec: Amitava Mitra , Sandra Suarez-Sharp , Xavier J H Pepin , Talia Flanagan , Yang Zhao , Evangelos Kotzagiorgis , Neil Parrott , Satish Sharan , Christophe Tistaert , Tycho Heimbach , Banu Zolnik , Erik Sjögren , Fang Wu , Om Anand , Shefali Kakar , Min Li , Shereeni Veerasingham , Shinichi Kijima , Gustavo Mendes Lima Santos , Baoming Ning , Kimberly Raines , Greg Rullo , Haritha Mandula , Poonam Delvadia , Jennifer Dressman , Paul A Dickinson , Andrew Babiskin

Physiologically Based Pharmacokinetic Modeling Approach to Identify the Drug-Drug Interaction Mechanism of Nifedipine and a Proton Pump Inhibitor, Omeprazole.

European journal of drug metabolism and pharmacokinetics

Avec: Maxime Le Merdy , Ming-Liang Tan , Dajun Sun , Zhanglin Ni , Sue-Chih Lee , Andrew Babiskin , Liang Zhao

Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.

Clinical pharmacology and therapeutics

Avec: Jieon Lee , Kairui Feng , Denise S Conti , Ross Walenga , Michael Wientjes , Hezhen Wang , Bryan Newman , Liangfeng Han , Sneha Dhapare , Elizabeth Bielski , Andrew Babiskin , Fang Wu , Mark Donnelly , Myong-Jin Kim , Wenlei Jiang , Markham C Luke , Lanyan Fang , Liang Zhao

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension.

The AAPS journal

Avec: Maxime Le Merdy , Jianghong Fan , Michael B Bolger , Viera Lukacova , Jessica Spires , Eleftheria Tsakalozou , Vikram Patel , Lin Xu , Sharron Stewart , Ashok Chockalingam , Suresh Narayanasamy , Rodney Rouse , Murali Matta , Andrew Babiskin , Darby Kozak , Stephanie Choi , Lei Zhang , Robert Lionberger , Liang Zhao

Research and Education Needs for Complex Generics.

Pharmaceutical research

Avec: Sydney Stern , Jill Coghlan , Vishalakshi Krishnan , Sam G Raney , Andrew Babiskin , Wenlei Jiang , Robert Lionberger , Xiaoming Xu , Anna Schwendeman , James E Polli

Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective.

Advanced drug delivery reviews

Avec: Bryan Newman , Andrew Babiskin , Elizabeth Bielski , Susan Boc , Sneha Dhapare , Lanyan Fang , Katharine Feibus , Anubhav Kaviratna , Bing V Li , Markham C Luke , Tian Ma , Michael Spagnola , Ross L Walenga , Zhong Wang , Liang Zhao , Nashwa El-Gendy , Craig M Bertha , Mohammed Abd El-Shafy , Dhaval K Gaglani

Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation.

Pharmaceutical research

Avec: Maxime Le Merdy , Farah AlQaraghuli , Ming-Liang Tan , Ross Walenga , Andrew Babiskin , Liang Zhao , Viera Lukacova

Transport and deposition of beclomethasone dipropionate drug aerosols with varying ethanol concentration in severe asthmatic subjects.

International journal of pharmaceutics

Avec: Prathish K Rajaraman , Jiwoong Choi , Andrew Babiskin , Ross Walenga , Ching-Long Lin

Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations.

Pharmaceutical research

Avec: Maxime Le Merdy , Jessica Spires , Viera Lukacova , Ming-Liang Tan , Andrew Babiskin , Xiaoming Xu , Liang Zhao , Michael B Bolger

In vitro evaluation of regional nasal drug delivery using multiple anatomical nasal replicas of adult human subjects and two nasal sprays.

International journal of pharmaceutics

Avec: Michele Dario Manniello , Sana Hosseini , Ali Alfaifi , Amir R Esmaeili , Arun V Kolanjiyil , Ross Walenga , Andrew Babiskin , Dennis Sandell , Reza Mohammadi , Theodore Schuman , Michael Hindle , Laleh Golshahi

Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions.

Therapeutic innovation & regulatory science

Avec: Saranrat Wittayanukorn , Matthew Rosenberg , Andreas Schick , Meng Hu , Zhong Wang , Andrew Babiskin , Robert Lionberger , Liang Zhao

Physiologically-Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations.

Clinical pharmacology and therapeutics

Avec: Eleftheria Tsakalozou , Khondoker Alam , Andrew Babiskin , Liang Zhao

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.

CPT: pharmacometrics & systems pharmacology

Avec: Andrew Babiskin , Fang Wu , Youssef Mousa , Ming-Liang Tan , Eleftheria Tsakalozou , Ross L Walenga , Miyoung Yoon , Sam G Raney , James E Polli , Anna Schwendeman , Vishalakshi Krishnan , Lanyan Fang , Liang Zhao

Transport and deposition of hygroscopic particles in asthmatic subjects with and without airway narrowing.

Journal of aerosol science

Avec: Prathish K Rajaraman , Jiwoong Choi , Eric A Hoffman , Patrick T O'Shaughnessy , Sanghun Choi , Renishkumar Delvadia , Andrew Babiskin , Ross Walenga , Ching-Long Lin

Use of anatomically-accurate 3-dimensional nasal airway models of adult human subjects in a novel methodology to identify and evaluate the internal nasal valve.

Computers in biology and medicine

Avec: Sana Hosseini , Theodore A Schuman , Ross Walenga , John V Wilkins , Andrew Babiskin , Laleh Golshahi

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Clinical pharmacology and therapeutics

Avec: Meng Hu , Andrew Babiskin , Saranrat Wittayanukorn , Andreas Schick , Matthew Rosenberg , Xiajing Gong , Myong-Jin Kim , Lei Zhang , Robert Lionberger , Liang Zhao

1D network simulations for evaluating regional flow and pressure distributions in healthy and asthmatic human lungs.

Journal of applied physiology (Bethesda, Md. : 1985)

Avec: Sanghun Choi , Sujin Yoon , Jichan Jeon , Chunrui Zou , Jiwoong Choi , Merryn H Tawhai , Eric A Hoffman , Renishkumar Delvadia , Andrew Babiskin , Ross Walenga , Ching-Long Lin

In Vitro Biopredictive Methods: A Workshop Summary Report.

Journal of pharmaceutical sciences

Avec: Xavier J H Pepin , Jennifer Dressman , Neil Parrott , Poonam Delvadia , Amitava Mitra , Xinyuan Zhang , Andrew Babiskin , Vidula Kolhatkar , Paul Seo , Lynne S Taylor , Erik Sjögren , James M Butler , Edmund Kostewicz , Christer Tannergren , Mirko Koziolek , Filippos Kesisoglou , André Dallmann , Yang Zhao , Sandra Suarez-Sharp

A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac-trumpet model.

Journal of computational design and engineering

Avec: Ravishekar Ravi Kannan , Narender Singh , Andrzej Przekwas , Xianlian Alex Zhou , Ross Walenga , Andrew Babiskin

Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective.

Advanced drug delivery reviews

Avec: Nashwa El-Gendy , Craig M Bertha , Mohammed Abd El-Shafy , Dhaval K Gaglani , Andrew Babiskin , Elizabeth Bielski , Susan Boc , Sneha Dhapare , Lanyan Fang , Katharine Feibus , Anubhav Kaviratna , Bing V Li , Markham C Luke , Tian Ma , Bryan Newman , Michael Spagnola , Ross L Walenga , Liang Zhao

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.

Journal of pharmaceutical sciences

Avec: Xavier J H Pepin , Neil Parrott , Jennifer Dressman , Poonam Delvadia , Amitava Mitra , Xinyuan Zhang , Andrew Babiskin , Vidula Kolhatkar , Sandra Suarez-Sharp

A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach.

CPT: pharmacometrics & systems pharmacology

Avec: Roberto Gomeni , Lanyan Lucy Fang , Françoise Bressolle-Gomeni , Thomas J Spencer , Stephen V Faraone , Andrew Babiskin

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

CPT: pharmacometrics & systems pharmacology

Avec: Eleftheria Tsakalozou , Andrew Babiskin , Liang Zhao

Anatomically realistic nasal replicas capturing the range of nasal spray drug delivery in adults.

International journal of pharmaceutics

Avec: Ali Alfaifi , Sana Hosseini , Amir R Esmaeili , Ross Walenga , Andrew Babiskin , Theodore Schuman , Worth Longest , Michael Hindle , Laleh Golshahi

Use of physiologically-based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended-release nifedipine.

CPT: pharmacometrics & systems pharmacology

Avec: Ming-Liang Tan , Zongming Gao , Andrew Babiskin , Myong-Jin Kim , Lanyan Fang , Lei Zhang , Liang Zhao

Establishing quantitative relationships between changes in nasal spray in vitro metrics and drug delivery to the posterior nasal region.

International journal of pharmaceutics

Avec: Arun V Kolanjiyil , Ross Walenga , Andrew Babiskin , Laleh Golshahi , Michael Hindle , Worth Longest

Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report.

CPT: pharmacometrics & systems pharmacology

Avec: Ming-Liang Tan , Sajeev Chandran , Rebeka Jereb , Khondoker Alam , Robert Bies , Darby Kozak , Ross Walenga , Maxime Le Merdy , Andrew Babiskin

Computational Model of In Vivo Corneal Pharmacokinetics and Pharmacodynamics of Topically Administered Ophthalmic Drug Products.

Pharmaceutical research

Avec: Carrie German , Zhijian Chen , Andrzej Przekwas , Ross Walenga , Andrew Babiskin , Liang Zhao , Jianghong Fan , Ming-Liang Tan

Topical pharmacokinetics of brinzolamide suspensions in rabbits and variability analysis for sample size and design considerations.

International journal of pharmaceutics

Avec: Vatsala Naageshwaran , Hélène Bigonne , Glenwood Gum , Spundana Malla , Charity Del Sol , Charles Bon , Xiaoming Xu , Anh Vo , William Smith , Andre O'Reilly Beringhs , Darby Kozak , Ming-Liang Tan , Andrew Babiskin , Arto Urtti , Eva M Del Amo , Veli-Pekka Ranta

Réseau de co-auteurs

Liang Zhao 15 collaborations

Ross Walenga 12 collaborations

Ming-Liang Tan 9 collaborations

Maxime Le Merdy 6 collaborations

Lanyan Fang 5 collaborations

Eleftheria Tsakalozou 4 collaborations

Robert Lionberger 4 collaborations

Laleh Golshahi 4 collaborations

Amitava Mitra 3 collaborations

Sandra Suarez-Sharp 3 collaborations

Xavier J H Pepin 3 collaborations

Neil Parrott 3 collaborations

Fang Wu 3 collaborations

Poonam Delvadia 3 collaborations

Jennifer Dressman 3 collaborations

Bryan Newman 3 collaborations

Sneha Dhapare 3 collaborations

Elizabeth Bielski 3 collaborations

Myong-Jin Kim 3 collaborations

Markham C Luke 3 collaborations

Viera Lukacova 3 collaborations

Darby Kozak 3 collaborations

Lei Zhang 3 collaborations

Xiaoming Xu 3 collaborations

Ross L Walenga 3 collaborations

Jiwoong Choi 3 collaborations

Ching-Long Lin 3 collaborations

Sana Hosseini 3 collaborations

Michael Hindle 3 collaborations

Yang Zhao 2 collaborations

Erik Sjögren 2 collaborations

Wenlei Jiang 2 collaborations

Jianghong Fan 2 collaborations

Michael B Bolger 2 collaborations

Jessica Spires 2 collaborations

Vishalakshi Krishnan 2 collaborations

Sam G Raney 2 collaborations

Anna Schwendeman 2 collaborations

James E Polli 2 collaborations

Susan Boc 2 collaborations

Katharine Feibus 2 collaborations

Anubhav Kaviratna 2 collaborations

Bing V Li 2 collaborations

Tian Ma 2 collaborations

Michael Spagnola 2 collaborations

Zhong Wang 2 collaborations

Nashwa El-Gendy 2 collaborations

Craig M Bertha 2 collaborations

Mohammed Abd El-Shafy 2 collaborations

Dhaval K Gaglani 2 collaborations

Prathish K Rajaraman 2 collaborations

Ali Alfaifi 2 collaborations

Amir R Esmaeili 2 collaborations

Arun V Kolanjiyil 2 collaborations

Theodore Schuman 2 collaborations

Saranrat Wittayanukorn 2 collaborations

Matthew Rosenberg 2 collaborations

Andreas Schick 2 collaborations

Meng Hu 2 collaborations

Khondoker Alam 2 collaborations

Eric A Hoffman 2 collaborations

Sanghun Choi 2 collaborations

Renishkumar Delvadia 2 collaborations

Xinyuan Zhang 2 collaborations

Vidula Kolhatkar 2 collaborations

Andrzej Przekwas 2 collaborations

Worth Longest 2 collaborations

Talia Flanagan 1 collaboration

Evangelos Kotzagiorgis 1 collaboration

Satish Sharan 1 collaboration

Christophe Tistaert 1 collaboration

Tycho Heimbach 1 collaboration

Banu Zolnik 1 collaboration

Om Anand 1 collaboration

Shefali Kakar 1 collaboration

Min Li 1 collaboration

Shereeni Veerasingham 1 collaboration

Shinichi Kijima 1 collaboration

Gustavo Mendes Lima Santos 1 collaboration

Baoming Ning 1 collaboration

Kimberly Raines 1 collaboration

Greg Rullo 1 collaboration

Haritha Mandula 1 collaboration

Paul A Dickinson 1 collaboration

Dajun Sun 1 collaboration

Zhanglin Ni 1 collaboration

Sue-Chih Lee 1 collaboration

Jieon Lee 1 collaboration

Kairui Feng 1 collaboration

Denise S Conti 1 collaboration

Michael Wientjes 1 collaboration

Hezhen Wang 1 collaboration

Liangfeng Han 1 collaboration

Mark Donnelly 1 collaboration

Vikram Patel 1 collaboration

Lin Xu 1 collaboration

Sharron Stewart 1 collaboration

Ashok Chockalingam 1 collaboration

Suresh Narayanasamy 1 collaboration

Rodney Rouse 1 collaboration

Murali Matta 1 collaboration

Stephanie Choi 1 collaboration

Sydney Stern 1 collaboration

Jill Coghlan 1 collaboration

Farah AlQaraghuli 1 collaboration

Michele Dario Manniello 1 collaboration

Dennis Sandell 1 collaboration

Reza Mohammadi 1 collaboration

Youssef Mousa 1 collaboration

Miyoung Yoon 1 collaboration

Patrick T O'Shaughnessy 1 collaboration

Theodore A Schuman 1 collaboration

John V Wilkins 1 collaboration

Xiajing Gong 1 collaboration

Sujin Yoon 1 collaboration

Jichan Jeon 1 collaboration

Chunrui Zou 1 collaboration

Merryn H Tawhai 1 collaboration

Paul Seo 1 collaboration

Lynne S Taylor 1 collaboration

James M Butler 1 collaboration

Edmund Kostewicz 1 collaboration

Christer Tannergren 1 collaboration

Mirko Koziolek 1 collaboration

Filippos Kesisoglou 1 collaboration

André Dallmann 1 collaboration

Ravishekar Ravi Kannan 1 collaboration

Narender Singh 1 collaboration

Xianlian Alex Zhou 1 collaboration

Roberto Gomeni 1 collaboration

Lanyan Lucy Fang 1 collaboration

Françoise Bressolle-Gomeni 1 collaboration

Thomas J Spencer 1 collaboration

Stephen V Faraone 1 collaboration

Zongming Gao 1 collaboration

Sajeev Chandran 1 collaboration

Rebeka Jereb 1 collaboration

Robert Bies 1 collaboration

Carrie German 1 collaboration

Zhijian Chen 1 collaboration

Vatsala Naageshwaran 1 collaboration

Hélène Bigonne 1 collaboration

Glenwood Gum 1 collaboration

Spundana Malla 1 collaboration

Charity Del Sol 1 collaboration

Charles Bon 1 collaboration

Anh Vo 1 collaboration

William Smith 1 collaboration

Andre O'Reilly Beringhs 1 collaboration

Arto Urtti 1 collaboration

Eva M Del Amo 1 collaboration

Veli-Pekka Ranta 1 collaboration