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 ◽

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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 ◽

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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 ◽

Author(s):

Amitava Mitra

Keyword(s):

Drug Development ◽

Generic Drug ◽

Oral Absorption ◽

Physiologically Based ◽

Absorption Modeling

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Decision Science for Generic Drug Development and Review

The Journal of Clinical Pharmacology ◽

10.1002/jcph.929 ◽

2019 ◽

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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A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms

Journal of Pharmacokinetics and Pharmacodynamics ◽

10.1007/s10928-021-09778-5 ◽

2021 ◽

Author(s):

Nan-Hung Hsieh ◽

Frédéric Y. Bois ◽

Eleftheria Tsakalozou ◽

Zhanglin Ni ◽

Miyoung Yoon ◽

...

Keyword(s):

Drug Development ◽

Generic Drug ◽

Dosage Forms ◽

Oral Dosage ◽

Modeling Approach ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Absorption Modeling ◽

Oral Dosage Forms ◽

Development Application

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Neuro-fuzzy Models as an IVIVR Tool and Their Applicability in Generic Drug Development

The AAPS Journal ◽

10.1208/s12248-014-9569-8 ◽

2014 ◽

Vol 16 (2) ◽

pp. 324-334 ◽

Author(s):

Jerneja Opara ◽

Igor Legen

Keyword(s):

Drug Development ◽

Generic Drug ◽

Fuzzy Models ◽

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Guest Editor’s Note: Practical and Regulatory Issues on New Drug, New Dosage Form, and Generic Drug Development

Drug Information Journal ◽

10.1177/009286159703100411 ◽

1997 ◽

Vol 31 (4) ◽

pp. 1145-1147

Author(s):

Oliver Yoa-Pu Hu ◽

Shein-Chung Chow

Keyword(s):

Drug Development ◽

Generic Drug ◽

Dosage Form ◽

Regulatory Issues ◽

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Bioequivalence, Bioassays, and Biowaivers: How Integrated Testing Can Accelerate Generic Drug Development

Genetic Engineering & Biotechnology News ◽

10.1089/gen.40.09.14 ◽

2020 ◽

Vol 40 (9) ◽

pp. 56-58

Author(s):

Vatsala Naageshwaran

Keyword(s):

Drug Development ◽

Generic Drug ◽

Integrated Testing

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Opportunities and challenges to implementing Quality by Design approach in generic drug development

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1057/jgm.2009.37 ◽

2009 ◽

Vol 7 (1) ◽

pp. 60-73 ◽

Author(s):

Ramaji K Varu ◽

Amit Khanna

Keyword(s):

Drug Development ◽

Generic Drug ◽

Quality By Design ◽

Design Approach ◽

Quality By Design Approach

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An Analytical Hierarchy Process (AHP) Approach to Risk Analysis: A Case Study of a New Generic Drug Development Process

Journal of Pharmaceutical Innovation ◽

10.1007/s12247-017-9298-5 ◽

2017 ◽

Vol 12 (4) ◽

pp. 319-326 ◽

Author(s):

Chatchai Raka ◽

Jirapan Liangrokapart

Keyword(s):

Risk Analysis ◽

Drug Development ◽

Generic Drug ◽

Analytical Hierarchy Process ◽

Development Process ◽

Drug Development Process ◽

Hierarchy Process

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