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Dissolution Testing for Generic Drugs: An FDA Perspective

The AAPS journal, 2011-09, Vol.13 (3), p.328, Article 328

2011

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BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements

The AAPS journal, 2016-05, Vol.18 (3), p.612-618

2016

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Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration

The Annals of pharmacotherapy, 2009-10, Vol.43 (10), p.1583-1597

2009

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Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

The AAPS journal, 2011-03, Vol.13 (1), p.59-71

2011

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The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation

International journal of pharmaceutics, 2011-10, Vol.418 (2), p.151-160

2011

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International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

The AAPS journal, 2013-10, Vol.15 (4), p.974-990

2013

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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

The AAPS journal, 2012-12, Vol.14 (4), p.915-924

2012

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Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

The AAPS journal, 2015-01, Vol.17 (1), p.121-133

2015

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Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules

The AAPS journal, 2015-01, Vol.17 (1), p.206-215

2015

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Impact of Biopharmaceutics Classification System-Based Biowaivers

Molecular pharmaceutics, 2010-10, Vol.7 (5), p.1539-1544

2010

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Use of In Vitro–In Vivo Correlation to Predict the Pharmacokinetics of Several Products Containing a BCS Class 1 Drug in Extended Release Matrices

Pharmaceutical research, 2013-01, Vol.30 (1), p.179-190

2013

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Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications

Bioanalysis, 2014-01, Vol.6 (24), p.3349-3354

2014

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Using Partial Area for Evaluation of Bioavailability and Bioequivalence

Pharmaceutical research, 2011-08, Vol.28 (8), p.1939-1947

2011

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Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

The AAPS journal, 2008, Vol.10 (1), p.148-156

2008

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Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

The AAPS journal, 2012-12, Vol.14 (4), p.664-666

2012

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Bioequivalence study designs for generic solid oral anticancer drug products: Scientific and regulatory considerations

Journal of clinical pharmacology, 2013-12, Vol.53 (12), p.1252-1260

2013

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Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

The AAPS journal, 2012-12, Vol.14 (4), p.925-926

2012

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Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications

Bioanalysis, 2014-02, Vol.6 (4), p.441-445

2014

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Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

The AAPS journal, 2012-09, Vol.14 (3), p.627-638

2012

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Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA

The AAPS journal, 2012-03, Vol.14 (1), p.19-22

2012

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Generic drugs – safe, effective, and affordable

Dermatologic therapy, 2009-05, Vol.22 (3), p.229-240

2009

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Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

The AAPS journal, 2013-01, Vol.15 (1), p.10-14

2013

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PQRI Workshop Report: Application of IVIVC in Formulation Development

Dissolution technologies, 2014-05, Vol.21 (2), p.51-58

Van Buskirk, Glenn A.

2014

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Food effects in paediatric medicines development for products Co-administered with food

International journal of pharmaceutics, 2018-02, Vol.536 (2), p.530-535

2018

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Dissolution Testing for Generic Drugs: An FDA Perspective

BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation

International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules

Impact of Biopharmaceutics Classification System-Based Biowaivers

Use of In Vitro–In Vivo Correlation to Predict the Pharmacokinetics of Several Products Containing a BCS Class 1 Drug in Extended Release Matrices

Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications

Using Partial Area for Evaluation of Bioavailability and Bioequivalence

Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

Bioequivalence study designs for generic solid oral anticancer drug products: Scientific and regulatory considerations

Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications

Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA

Generic drugs – safe, effective, and affordable

Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report

PQRI Workshop Report: Application of IVIVC in Formulation Development

Food effects in paediatric medicines development for products Co-administered with food

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