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)
Resource Information
The item FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource) represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in Bates College.This item is available to borrow from 1 library branch.
Resource Information
The item FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource) represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in Bates College.
This item is available to borrow from 1 library branch.
- 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
- Language
- eng
- Extent
- 1 online resource (XIII, 465 p. 58 illus., 26 illus. in color.)
- 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
- Isbn
- 9781493912520
- Label
- FDA Bioequivalence Standards
- Title
- FDA Bioequivalence Standards
- Statement of responsibility
- edited by Lawrence X. Yu, Bing V. Li
- 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
- 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)
- 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)
- 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
Embed
Settings
Select options that apply then copy and paste the RDF/HTML data fragment to include in your application
Embed this data in a secure (HTTPS) page:
Layout options:
Include data citation:
<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.bates.edu/portal/FDA-Bioequivalence-Standards-edited-by-Lawrence/2x9O41uQL2o/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.bates.edu/portal/FDA-Bioequivalence-Standards-edited-by-Lawrence/2x9O41uQL2o/">FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.bates.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.bates.edu/">Bates College</a></span></span></span></span></div>
Note: Adjust the width and height settings defined in the RDF/HTML code fragment to best match your requirements
Preview
Cite Data - Experimental
Data Citation of the Item FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)
Copy and paste the following RDF/HTML data fragment to cite this resource
<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.bates.edu/portal/FDA-Bioequivalence-Standards-edited-by-Lawrence/2x9O41uQL2o/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.bates.edu/portal/FDA-Bioequivalence-Standards-edited-by-Lawrence/2x9O41uQL2o/">FDA Bioequivalence Standards, edited by Lawrence X. Yu, Bing V. Li, (electronic resource)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.bates.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.bates.edu/">Bates College</a></span></span></span></span></div>
