An edition of Generic drug product development
(2007)
Generic drug product development
bioequivalence issues
by Leon Shargel and Isadore Kanfer
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Subjects
Drugs, Drug development, Testing, Law and legislation, Pharmaceutical industry, Pharmaceutical technology, Medical / Pharmacology, Pharmacology, Medical, Medical / Nursing, Generic drugs, Drugs, generic substitution, Drugs, dosage, Solid dosage forms, Generic Drugs, Standards, Pharmaceutical Chemistry, Drug Approval, Tablets, Dosage forms, Therapeutic equivalency, Dosage Forms, Biopharmaceutics, Methods, Therapeutic EquivalencyShowing 11 featured editions. View all 11 editions?
| Edition | Availability |
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01
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence
2016, Taylor & Francis Group
in English
1420020021 9781420020021
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02
Generic Drug Product Development: Specialty Dosage Forms
2016, Taylor & Francis Group
in English
142002003X 9781420020038
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03
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, Second Edition
2016, Taylor & Francis Group
in English
1466599626 9781466599628
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04
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence
2016, Taylor & Francis Group
in English
0429132913 9780429132919
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05
Generic Drug Product Development: Solid Oral Dosage Forms
2013, Taylor & Francis Group, CRC Press/Taylor & Francis Group
in English
1420086359 9781420086355
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06
Generic Drug Product Development: Specialty Drug Products
December 15, 2010, Informa Healthcare
Hardcover
in English
- 1 edition
0849377862 9780849377860
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07
Generic drug product development: bioequivalence issues
2008, Informa Healthcare
in English
0849377846 9780849377846
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08
Generic Drug Product Development: Bioequivalence Issues
2007, Taylor & Francis Group
in English
1420020013 9781420020014
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09
Generic drug product development
2007, CRC, Taylor & Francis [distributor]
in English
0849377862 9780849377860
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10
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11
Generic Drug Product Development: Bioequivalence Issues
2007, Taylor & Francis Group
in English
0429132905 9780429132902
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Book Details
Table of Contents
Introduction
bioequivalence issues / Isadore Kanfer and Leon Shargel
Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber
Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer
Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel
Bioequivalence using clinical endpoint studies / Christopher Hendy
Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi
Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon
Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme
Role of metabolites in bioequivalence assessent / André Jackson
Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali
Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer
Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci ... [et al.].
Edition Notes
Includes bibliographical references and index.
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| December 23, 2020 | Edited by MARC Bot | import existing book |
| November 14, 2020 | Edited by MARC Bot | import existing book |
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| August 14, 2020 | Edited by ImportBot | import existing book |
| December 9, 2009 | Created by WorkBot | add works page |