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Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs

Pharmaceutical research, 2023-02, Vol.40 (2), p.337-357

2023

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Pharmacokinetic aspects and in vitro-in vivo correlation potential for lipid-based formulations

Acta pharmaceutica Sinica. B, 2014-10, Vol.4 (5), p.333-349

2014

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Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Journal of pharmaceutical sciences, 2021-12, Vol.110 (12), p.3896-3906

2021

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Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

Pharmaceuticals (Basel, Switzerland), 2024-07, Vol.17 (7), p.876

2024

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International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario

Chromatographia, 2011-02, Vol.73 (3-4), p.201-217

2011

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Physiologically based pharmacokinetic modeling (PBPK) to predict drug-drug interactions for encorafenib. Part II. Prospective predictions in hepatic and renal impaired populations with clinical inhibitors and inducers

Xenobiotica, 2023-05, Vol.53 (5), p.339-356

2023

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Physiologically based pharmacokinetic modelling to predict drug–drug interactions for encorafenib. Part I. Model building, validation, and prospective predictions with enzyme inhibitors, inducers, and transporter inhibitors

Xenobiotica, 2023-05, Vol.53 (5), p.366-381

2023

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Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?

The AAPS journal, 2024-06, Vol.26 (4), Article 66

2024

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Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro,In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions

The AAPS journal, 2023-07, Vol.25 (5), p.77-77, Article 77

2023

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Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets

Drug development and industrial pharmacy, 2021-05, Vol.47 (5), p.778-789

2021

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Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions

Xenobiotica, 2023-07, Vol.ahead-of-print (ahead-of-print), p.1-19

2023

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Applications of PBPK/PBBM modeling in generic product development: An industry perspective

Journal of drug delivery science and technology, 2022-03, Vol.69, p.103152, Article 103152

2022

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Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics - a case study and utility in regulatory justifications

Xenobiotica, 2023-11, Vol.53 (10-11), p.587-602

2023

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Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations

AAPS PharmSciTech, 2024-05, Vol.25 (5), p.118-118, Article 118

2024

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Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

Journal of pharmaceutical sciences, 2022-12, Vol.111 (12), p.3397-3410

2022

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Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development

AAPS PharmSciTech, 2022-01, Vol.23 (1), p.53-53, Article 53

2022

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Predicting transporter mediated drug–drug interactions via static and dynamic physiologically based pharmacokinetic modeling: A comprehensive insight on where we are now and the way forward

Biopharmaceutics & drug disposition, 2023-06, Vol.44 (3), p.195-220

2023

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Biopredictive Dissolutions for Conventional Oral IR, MR and Non-Oral Formulations – Current Status and Future Opportunities

Journal of drug delivery science and technology, 2024-08, Vol.97, p.105807, Article 105807

2024

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Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

AAPS PharmSciTech, 2023-02, Vol.24 (2), p.59-59, Article 59

2023

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Prediction of ARA/PPI Drug-Drug Interactions at the Drug Discovery and Development Interface

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.87-101

2019

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Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Journal of pharmaceutical sciences, 2024-02, Vol.113 (2), p.345-358

2024

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Dissolution Profiles Comparison Using Conventional and Bias Corrected and Accelerated f2 Bootstrap Approaches with Different Software’s: Impact of Variability, Sample Size and Number of Bootstraps

AAPS PharmSciTech, 2023-12, Vol.25 (1), p.5-5, Article 5

2023

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Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products

The AAPS journal, 2024-01, Vol.26 (1), p.19-19, Article 19

2024

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In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies

Biopharmaceutics & drug disposition, 2021-07, Vol.42 (7), p.297-318

2021

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Application of rotatable central composite design in the preparation and optimization of poly(lactic-co-glycolic acid) nanoparticles for controlled delivery of paclitaxel

Drug development and industrial pharmacy, 2010-11, Vol.36 (11), p.1377-1387

2010

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Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs

Pharmacokinetic aspects and in vitro-in vivo correlation potential for lipid-based formulations

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario

Physiologically based pharmacokinetic modeling (PBPK) to predict drug-drug interactions for encorafenib. Part II. Prospective predictions in hepatic and renal impaired populations with clinical inhibitors and inducers

Physiologically based pharmacokinetic modelling to predict drug–drug interactions for encorafenib. Part I. Model building, validation, and prospective predictions with enzyme inhibitors, inducers, and transporter inhibitors

Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?

Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro,In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions

Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets

Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions

Applications of PBPK/PBBM modeling in generic product development: An industry perspective

Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics - a case study and utility in regulatory justifications

Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations

Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development

Predicting transporter mediated drug–drug interactions via static and dynamic physiologically based pharmacokinetic modeling: A comprehensive insight on where we are now and the way forward

Biopredictive Dissolutions for Conventional Oral IR, MR and Non-Oral Formulations – Current Status and Future Opportunities

Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

Prediction of ARA/PPI Drug-Drug Interactions at the Drug Discovery and Development Interface

Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Dissolution Profiles Comparison Using Conventional and Bias Corrected and Accelerated f2 Bootstrap Approaches with Different Software’s: Impact of Variability, Sample Size and Number of Bootstraps

Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products

In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies

Application of rotatable central composite design in the preparation and optimization of poly(lactic-co-glycolic acid) nanoparticles for controlled delivery of paclitaxel

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