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G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS

The AAPS journal, 2014-09, Vol.16 (5), p.894-898

2014

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Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Annals of the New York Academy of Sciences, 2017-11, Vol.1407 (1), p.39-49

2017

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Molecular Properties of WHO Essential Drugs and Provisional Biopharmaceutical Classification

Molecular pharmaceutics, 2004-01, Vol.1 (1), p.85-96

2004

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FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

AAPS PharmSciTech, 2011-06, Vol.12 (2), p.782-794

2011

Volltextzugriff (PDF)

Bioequivalence of Topical Formulations in Humans: Evaluation by Dermal Microdialysis Sampling and the Dermatopharmacokinetic Method

Journal of investigative dermatology, 2007-01, Vol.127 (1), p.170-178

2007

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Dissolution testing as a prognostic tool for oral drug absorption : Immediate release dosage forms

Pharmaceutical research, 1998, Vol.15 (1), p.11-22

1998

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Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 Years

Journal of pharmaceutical sciences, 2012-11, Vol.101 (11), p.4075-4099

2012

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In vitro release test (IVRT): Principles and applications

International journal of pharmaceutics, 2022-10, Vol.626, p.122159-122159, Article 122159

2022

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A science based approach to topical drug classification system (TCS)

International journal of pharmaceutics, 2015-08, Vol.491 (1-2), p.21-25

2015

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Raltegravir Potassium

Journal of pharmaceutical sciences, 2024-08

2024

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine

Journal of pharmaceutical sciences, 2024-06

2024

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate

Journal of pharmaceutical sciences, 2024-02, Vol.113 (2), p.386-395

2024

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Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays

Pharmaceutical research, 2007-10, Vol.24 (10), p.1962-1973

2007

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Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride

Journal of pharmaceutical sciences, 2023-03, Vol.112 (3), p.634-639

2023

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Progressive Applications of Dissolution, Its Impact, and Implications in the Pharmaceutical World

Journal of pharmaceutical sciences, 2013-09, Vol.102 (9), p.2895-2897

Shah, Vinod P.

2013

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate

Journal of pharmaceutical sciences, 2017-10, Vol.106 (10), p.2930-2945

2017

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride

Journal of pharmaceutical sciences, 2023-04, Vol.112 (4), p.893-903

2023

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Commonality between BCS and TCS

International journal of pharmaceutics, 2016-07, Vol.509 (1-2), p.35-40

2016

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Are European marketed acyclovir 5% cream products similar? Comparison with EU and US reference product

Drug development and industrial pharmacy, 2021-06, Vol.47 (6), p.990-1000

2021

Volltextzugriff (PDF)

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

Annals of the New York Academy of Sciences, 2021-10, Vol.1502 (1), p.5-13

2021

Volltextzugriff (PDF)

Report on the AAPS Immunogenicity Guidance Forum

The AAPS journal, 2019-07, Vol.21 (4), p.55-55, Article 55

2019

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine

Journal of pharmaceutical sciences, 2021-05, Vol.110 (5), p.1935-1947

2021

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Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal ® Consta

International journal of pharmaceutics, 2011-11, Vol.420 (2), p.198-205

2011

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

Journal of pharmaceutical sciences, 2022-01, Vol.111 (1), p.2-13

2022

Volltextzugriff (PDF)

Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

The AAPS journal, 2008-06, Vol.10 (2), p.373-379

2008

Volltextzugriff (PDF)

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G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Molecular Properties of WHO Essential Drugs and Provisional Biopharmaceutical Classification

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

Bioequivalence of Topical Formulations in Humans: Evaluation by Dermal Microdialysis Sampling and the Dermatopharmacokinetic Method

Dissolution testing as a prognostic tool for oral drug absorption : Immediate release dosage forms

Impact of the Pharmaceutical Sciences on Health Care: A Reflection over the Past 50 Years

In vitro release test (IVRT): Principles and applications

A science based approach to topical drug classification system (TCS)

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Raltegravir Potassium

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays

Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride

Progressive Applications of Dissolution, Its Impact, and Implications in the Pharmaceutical World

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride

Commonality between BCS and TCS

Are European marketed acyclovir 5% cream products similar? Comparison with EU and US reference product

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

Report on the AAPS Immunogenicity Guidance Forum

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine

Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal ® Consta

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

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