Dissolution Testing in Generic Drug Development: Methods, Requirements, and Regulatory Expectations/Requirements

1994 ◽

Vol 12 (12) ◽

pp. 1519-1527 ◽

Cited By ~ 19

Author(s):

Ketan P. Shah ◽

Ming Chang ◽

Christopher M. Riley

Keyword(s):

Drug Development ◽

Development Studies ◽

Dissolution Testing

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Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing

Drugs and the Pharmaceutical Sciences - Generic Drug Development ◽

10.1201/9781420030419.ch14 ◽

2004 ◽

pp. 343-371

Author(s):

Arthur Tsien

Keyword(s):

Drug Development ◽

Generic Drug

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Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1231 ◽

2018 ◽

Vol 105 (3) ◽

pp. 672-683 ◽

Cited By ~ 6

Author(s):

Emily A.F. Holmes ◽

Catrin Plumpton ◽

Gus A. Baker ◽

Ann Jacoby ◽

Adele Ring ◽

...

Keyword(s):

Drug Development ◽

Antiepileptic Drugs ◽

Discrete Choice Experiment ◽

Discrete Choice ◽

Choice Experiment ◽

Risk Assessments ◽

Development Methods ◽

Patient Focused Drug Development

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Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions

AAPS PharmSciTech ◽

10.1208/s12249-020-01662-8 ◽

2020 ◽

Vol 21 (5) ◽

Author(s):

Dorota Danielak ◽

Bartłomiej Milanowski ◽

Krzysztof Wentowski ◽

Maria Nogowska ◽

Michał Kątny ◽

...

Keyword(s):

Drug Development ◽

Development Process ◽

Bioequivalence Study ◽

Drug Development Process ◽

Dissolution Testing ◽

Physiologically Based

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Bioequivalence Studies in Drug Development, Methods and Applications by D. HAUSCHKE, V. STEINIJANS, and I. PIGEOT

Biometrics ◽

10.1111/j.1541-0420.2007.00856_4.x ◽

2007 ◽

Vol 63 (3) ◽

pp. 969-970

Author(s):

Shein-Chung Chow

Keyword(s):

Drug Development ◽

Development Methods

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Maximizing the Role of Physiologically Based Oral Absorption Modeling in Generic Drug Development

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1242 ◽

2018 ◽

Vol 105 (2) ◽

pp. 307-309 ◽

Cited By ~ 5

Author(s):

Amitava Mitra

Keyword(s):

Drug Development ◽

Generic Drug ◽

Oral Absorption ◽

Physiologically Based ◽

Absorption Modeling

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Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing

Generic Drug Product Development - Drugs and the Pharmaceutical Sciences ◽

10.1201/b15569-16 ◽

2013 ◽

pp. 333-370

Author(s):

Arthur Tsien

Keyword(s):

Drug Development ◽

Generic Drug

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Decision Science for Generic Drug Development and Review

The Journal of Clinical Pharmacology ◽

10.1002/jcph.929 ◽

2019 ◽

Cited By ~ 1

Author(s):

Robert Lionberger

Keyword(s):

Drug Development ◽

Generic Drug ◽

Decision Science

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Applications of Adaptive Designs in Generic Drug Development

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.2050 ◽

2020 ◽

Author(s):

Jieon Lee ◽

Kairui Feng ◽

Mingjiang Xu ◽

Xiajing Gong ◽

Wanjie Sun ◽

...

Keyword(s):

Drug Development ◽

Generic Drug ◽

Adaptive Designs

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Bioequivalence studies in drug development methods and applications Hauschke D, Steinijans V, Pigeot I (2007) Wiley, Chichester, England, www.wiley.com; $110.00, £61.95

Pharmaceutical Statistics ◽

10.1002/pst.488 ◽

2011 ◽

Vol 11 (2) ◽

pp. 191-191

Author(s):

Stevens Julious

Keyword(s):

Drug Development ◽

Development Methods

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Dissolution Testing in Generic Drug Development: Methods, Requirements, and Regulatory Expectations/Requirements

Automated analytical systems for drug development studies. II — A system for dissolution testing

Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing

Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs

Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions

Bioequivalence Studies in Drug Development, Methods and Applications by D. HAUSCHKE, V. STEINIJANS, and I. PIGEOT

Maximizing the Role of Physiologically Based Oral Absorption Modeling in Generic Drug Development

Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing

Decision Science for Generic Drug Development and Review

Applications of Adaptive Designs in Generic Drug Development

Bioequivalence studies in drug development methods and applications Hauschke D, Steinijans V, Pigeot I (2007) Wiley, Chichester, England, www.wiley.com; $110.00, £61.95

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