Coverart for item
The Resource FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)

FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)

Label
FDA Bioequivalence Standards
Title
FDA Bioequivalence Standards
Statement of responsibility
edited by Lawrence X. Yu, Bing V. Li
Contributor
Subject
Language
eng
Summary
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards
Member of
Is part of
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Yu, Lawrence X
  • Li, Bing V
  • SpringerLink (Online service)
Series statement
AAPS Advances in the Pharmaceutical Sciences Series,
Series volume
13
http://library.link/vocab/subjectName
Pharmaceutical technology
Label
FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)
Instantiates
Publication
Contents
1 Bioequivalence History -- 2 Fundamentals of Bioequivalence -- 3 Basic Statistical Considerations -- 4 The Effects of Food on Drug Bioavailability and Bioequivalence -- 5 Bio waiver and Biopharmaceutics Classification System -- 6 Bioequivalence of Highly Variable Drugs -- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments -- 8 Bioequivalence for Narrow Therapeutic Index Drugs -- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies -- 10 Clinical Endpoint Bioequivalence Study -- 11 Bioequivalence for Liposomal Drug Products -- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract -- 13 Bioequivalence for Topical Drug Products -- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products -- 15 Bioequivalence: Modeling and Simulation -- 16 Bioanalysis
Control code
ssj0001353629
Dimensions
unknown
Extent
1 online resource (XIII, 465 p. 58 illus., 26 illus. in color.)
Form of item
online
Governing access note
Access restricted to subscribing institutions
Isbn
9781493912520
Other control number
10.1007/978-1-4939-1252-0
Other physical details
online resource
Specific material designation
remote
System control number
(WaSeSS)ssj0001353629
Label
FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)
Publication
Contents
1 Bioequivalence History -- 2 Fundamentals of Bioequivalence -- 3 Basic Statistical Considerations -- 4 The Effects of Food on Drug Bioavailability and Bioequivalence -- 5 Bio waiver and Biopharmaceutics Classification System -- 6 Bioequivalence of Highly Variable Drugs -- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments -- 8 Bioequivalence for Narrow Therapeutic Index Drugs -- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies -- 10 Clinical Endpoint Bioequivalence Study -- 11 Bioequivalence for Liposomal Drug Products -- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract -- 13 Bioequivalence for Topical Drug Products -- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products -- 15 Bioequivalence: Modeling and Simulation -- 16 Bioanalysis
Control code
ssj0001353629
Dimensions
unknown
Extent
1 online resource (XIII, 465 p. 58 illus., 26 illus. in color.)
Form of item
online
Governing access note
Access restricted to subscribing institutions
Isbn
9781493912520
Other control number
10.1007/978-1-4939-1252-0
Other physical details
online resource
Specific material designation
remote
System control number
(WaSeSS)ssj0001353629

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