The Resource Integrated pharmaceutics : applied preformulation, product design, and regulatory science, Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner

Integrated pharmaceutics : applied preformulation, product design, and regulatory science, Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner

Label
Integrated pharmaceutics : applied preformulation, product design, and regulatory science
Title
Integrated pharmaceutics
Title remainder
applied preformulation, product design, and regulatory science
Statement of responsibility
Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner
Creator
Contributor
Subject
Language
eng
Action
Committed to retain
Cataloging source
DNLM/DLC
http://library.link/vocab/creatorDate
1955-
http://library.link/vocab/creatorName
Al-Achi, Antoine
Dewey number
615.7
Illustrations
illustrations
Index
index present
LC call number
RS403
LC item number
.A43 2013
Literary form
non fiction
Nature of contents
bibliography
NLM call number
  • QV 744
  • QV 744
NLM item number
A316 2013
http://library.link/vocab/relatedWorkOrContributorName
  • Gupta, Mali Ram
  • Stagner, William Craig
http://library.link/vocab/subjectName
  • Pharmaceutical chemistry
  • Drugs
  • Drugs
  • Drugs
  • Chemistry, Pharmaceutical
  • Biopharmaceutics
  • Dosage Forms
  • Drug Design
  • Drug and Narcotic Control
Label
Integrated pharmaceutics : applied preformulation, product design, and regulatory science, Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Contents
  • Simple Linear Relationship
  • Non-Newtonian Systems
  • 7.4.
  • Viscoelasticity
  • 7.5.
  • Reynolds Number
  • 7.6.
  • Concluding Remarks
  • References
  • Glossary
  • ch. 8
  • 1.3.
  • Chemical Stability and Shelf-Life Determination
  • 8.1.
  • Introduction
  • 8.2.
  • Shelf-life Determination
  • 8.3.
  • Stability of Biotechnology Products
  • References
  • Glossary
  • ch. 9
  • Exponential Rules
  • Particle Science
  • 9.1.
  • Introduction
  • 9.2.
  • Particle Size Estimation and Distribution
  • 9.3.
  • Micronization
  • 9.4.
  • Particle Size Preparation and Reduction for Pulmonary Delivery
  • 9.5.
  • 1.4.
  • Polymeric Particulate Matter
  • 9.6.
  • Nanoparticles
  • 9.7.
  • Segregation of Particles
  • References
  • Glossary
  • ch. 10
  • Basic Statistics and Design of Experimental Concepts
  • 10.1.
  • Logarithmic Rules
  • Descriptive Statistics
  • 10.2.
  • Inferential Statistics
  • 10.3.
  • Statistical Applications in Quality Control Testing
  • 10.4.
  • Design of Experiment
  • References
  • Glossary
  • ch. 11
  • 1.5.
  • Formulation Development Concepts
  • 11.1.
  • Preformulation
  • 11.2.
  • Scale-up Considerations
  • 11.3.
  • Combination Products
  • 11.4.
  • Rate-Controlled Drug Delivery
  • 11.5.
  • Differential Equations
  • Drug Delivery Technologies for Improving Oral Delivery
  • 11.6.
  • Drug Delivery Technologies for Improving Transmucosal Delivery
  • 11.7.
  • Drug Delivery Technologies for Transdermal Delivery
  • 11.8.
  • Special Considerations for Biotechnology and Protein Delivery Systems
  • 11.9.
  • Drug-Excipient and Excipient-Excipient Interactions
  • 11.10.
  • 1.6.
  • Presence of Contaminants in a Formulation
  • 11.11.
  • Other Considerations
  • References
  • Glossary
  • pt. II
  • PRODUCT DESIGN
  • ch. 12
  • Product Design Process
  • 12.1.
  • Expanding and Reducing Formulas
  • Introduction
  • 12.2.
  • Formulation Design
  • 12.3.
  • Process Design
  • 12.4.
  • Container Closure System Design
  • References
  • Glossary
  • Appendixes
  • References
  • ch. 13
  • Tablet Product Design
  • 13.1.
  • Introduction
  • 13.2.
  • Formulation Design
  • 13.3.
  • Process Design
  • 13.4.
  • Container Closure System Design
  • Machine generated contents note:
  • Glossary
  • 13.5.
  • Risk Management
  • 13.6.
  • Attribute Tests
  • 13.7.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • ch. 14
  • ch. 2
  • Capsule Product Design
  • 14.1.
  • Introduction
  • 14.2.
  • Hard-Shell Capsules
  • 14.3.
  • Soft-Shell Capsules
  • 14.4.
  • Formulation and Process Optimization
  • 14.5.
  • Thermodynamics
  • Container Closure System
  • 14.6.
  • Risk Management
  • 14.7.
  • Attribute Tests
  • 14.8.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • 2.1.
  • ch. 15
  • Dispersed System Product Design
  • 15.1.
  • Introduction
  • 15.2.
  • Formulation Design
  • 15.3.
  • Process Design
  • 15.4.
  • Container Closure System Design
  • Introduction
  • 15.5.
  • Risk Management
  • 15.6.
  • Attribute Tests
  • 15.7.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • ch. 16
  • 2.2.
  • Aerosol Product Design
  • 16.1.
  • Introduction
  • 16.2.
  • Formulation Design
  • 16.3.
  • Container Closure System Design
  • 16.4.
  • Risk Management
  • 16.5.
  • Zeroth Law of Thermodynamics
  • Attribute Tests
  • 16.6.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendix
  • ch. 17
  • Sterile Injectable Product Design
  • 17.1.
  • Introduction
  • 2.3.
  • 17.2.
  • Formulation Design
  • 17.3.
  • Process Design
  • 17.4.
  • Container Closure System Design
  • 17.5.
  • Risk Management
  • 17.6.
  • Attribute Tests
  • First Law of Thermodynamics
  • 17.7.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • ch. 18
  • Ophthalmic Product Design
  • 18.1.
  • Introduction
  • 18.2.
  • 2.4.
  • Formulation Design
  • 18.3.
  • Process Design
  • 18.4.
  • Container Closure System Design
  • 18.5.
  • Attribute Tests
  • 18.6.
  • New Drug Application Stabilty Assessment
  • References
  • pt. I
  • Second Law of Thermodynamics
  • Glossary
  • Appendix
  • ch. 19
  • Transdermal Product Design
  • 19.1.
  • Introduction
  • 19.2.
  • Formulation Design
  • 19.3.
  • Conclusions
  • 2.5.
  • References
  • Glossary
  • Appendix
  • ch. 20
  • Oral Modified-Release Product Design
  • 20.1.
  • Introduction
  • 20.2.
  • Coatings
  • 20.3.
  • Third Law of Thermodynamics
  • Matrix Systems
  • 20.4.
  • Gastroretentive Devices
  • 20.5.
  • Osmotic Controlled Release Systems
  • 20.6.
  • Conclusions
  • References
  • Glossary
  • Appendix
  • 2.6.
  • pt. III
  • REGULATORY SCIENCE
  • ch. 21
  • Regulatory Practices and Guidelines
  • 21.1.
  • Worldwide Regulatory Agencies
  • 21.2.
  • Good Manufacturing Practice
  • 21.3.
  • FDA Inspection and Regulatory Actions
  • Polymorphism
  • References
  • Glossary
  • ch. 22
  • Regulations for Compounding Pharmacies
  • 22.1.
  • Introduction
  • 22.2.
  • Compounding Guidelines
  • 22.3.
  • FDA Compliance Policy Guides
  • 2.7.
  • 22.4.
  • Good Compounding Practices
  • 22.5.
  • Stability Criteria and Beyond-Use Dating of Compounded Preparations
  • 22.6.
  • Verification
  • 22.7.
  • Patient Counseling
  • 22.8.
  • Pharmacy Compounding Accreditation
  • Physical Stability of Crystal Forms
  • References
  • Glossary
  • Appendixes
  • ch. 23
  • IND and NDA Phase-Appropriate New Drug Development Process
  • 23.1.
  • Introduction
  • 23.2.
  • Preclinical Development Overview
  • 23.3.
  • 2.8.
  • Phase-Appropriate Clinical Trials Overview
  • 23.4.
  • Investigational New Drugs
  • 23.5.
  • NDA Review Process
  • References
  • Glossary
  • ch. 24
  • Generics, Biosimilars, and OTCS
  • 24.1.
  • Solubility
  • Generic Drugs
  • 24.2.
  • Biosimilar Drugs
  • 24.3.
  • Over-the-Counter Drugs
  • References
  • Glossary
  • Appendix
  • ch. 25
  • Accelerated New Drug Approval and Expedited Access of New Therapies
  • References
  • 25.1.
  • Introduction
  • 25.2.
  • Expedited Review and Approval of New Therapies
  • 25.3.
  • Expanded Access to New Therapies
  • 25.4.
  • Orphan Drugs
  • 25.5.
  • Pediatric Drugs
  • REFORMULATION
  • Glossary
  • 25.6.
  • Pediatric Drug Development and the Orphan Drug Act Incentives
  • 25.7.
  • Common EMEA/FDA Application for Orphan Medicinal Product Designation
  • References
  • Glossary
  • ch. 26
  • Post-Drug Approval Activities
  • 26.1.
  • Postmarket Requirements and Commitments
  • ch. 3
  • 26.2.
  • Postapproval Manufacturing Changes
  • 26.3.
  • Clinical Phase 4 Studies: Postmarketing Surveillance and Risk Assessment
  • 26.4.
  • Prescription Drug Advertising and Promotional Labeling Direct to Consumers
  • References
  • Glossary
  • Appendix
  • ch. 27
  • Solubility and Dissolution
  • Drug Master Files and EU Dossiers
  • 27.1.
  • Drug Master Files
  • 27.2.
  • European Marketing Authorization Dossiers
  • References
  • Glossary
  • ch. 28
  • Commissioning and Qualification
  • 28.1.
  • 3.1.
  • Regulatory Requirements
  • 28.2.
  • Preliminary C&Q Activities
  • 28.3.
  • Commissioning
  • 28.4.
  • Qualification and Validation
  • 28.5.
  • Qualification Protocols
  • 28.6.
  • Introduction
  • Process Validation
  • 28.7.
  • Cleaning Validation
  • 28.8.
  • Computer Systems Validation
  • 28.9.
  • Change Control
  • 28.10.
  • Revalidation
  • References
  • 3.2.
  • Glossary
  • ch. 29
  • Quality Systems and Controls
  • 29.1.
  • Pharmaceutical Quality System
  • 29.2.
  • Quality Systems Approach to CGMP Regulations
  • 29.3.
  • Inspection of Pharmaceutical Quality Control Laboratories
  • 29.4.
  • Concentration Units
  • Pharmacopeias
  • 29.5.
  • Analytical Instrument Qualification
  • 29.6.
  • Validation of Analytical Procedures
  • 29.7.
  • Stability Testing of New Drug Substances and Products
  • References
  • Glossary
  • Appendixes
  • 3.3.
  • ch. 30
  • Safety, Toxicology, and Pharmacogenomics
  • 30.1.
  • Nonclinical Safety Studies
  • 30.2.
  • Safety Pharmacology Studies
  • 30.3.
  • Carcinogenicity Studies of Pharmaceuticals
  • 30.4.
  • Genotoxicity Testing
  • What Should be Done When Alcohol is Prescribed in a Formulation
  • 30.5.
  • Immunotoxicity Studies
  • 30.6.
  • Safety Reporting Requirements
  • 30.7.
  • Pharmacogenomics
  • References
  • Glossary
  • Appendixes
  • ch. 31
  • 3.4.
  • Regulatory Science Initiatives for Advancing Public Health
  • 31.1.
  • Introduction
  • 31.2.
  • Advancing Regulatory Science for Public Health: The Promise of Regulatory Science
  • 31.3.
  • Advancing Regulatory Science at FDA: Strategic Plan for Regulatory Science
  • 31.4.
  • Collaborative Implementation Framework
  • References
  • ch. 1
  • Partition Coefficient
  • Glossary
  • 3.5.
  • Disintegration and Dissolution
  • 3.6.
  • Concluding Remarks
  • References
  • Glossary
  • ch. 4
  • Biological Aspects of Formulations
  • 4.1.
  • Mathematical Concepts
  • Introduction
  • 4.2.
  • Bioavailability and Bioequivalence
  • 4.3.
  • Protocols for Determining Bioequivalence
  • 4.4.
  • Bioequivalence Procedure
  • 4.5.
  • FDA-Approved Methods for Bioequivalence Studies
  • 4.6.
  • 1.1.
  • Approaches to Improving Bioavailability
  • References
  • Glossary
  • ch. 5
  • Interfacial Properties
  • 5.1.
  • Introduction
  • 5.2.
  • Liquid-Solid Interface
  • 5.3.
  • Introduction
  • Dosage-Form Applications
  • References
  • Glossary
  • ch. 6
  • Adsorption Phenomenon
  • 6.1.
  • Introduction
  • 6.2.
  • Adsorption on Filters
  • 6.3.
  • 1.2.
  • Adsorption of Proteins
  • References
  • Glossary
  • ch. 7
  • Rheological Principles
  • 7.1.
  • Introduction
  • 7.2.
  • Newtonian Systems
  • 7.3.
Dimensions
24 cm.
Extent
xix, 991 p.
Isbn
9780470596920
Isbn Type
(cloth)
Lccn
2012025748
Other physical details
ill.
System control number
  • (CaMWU)u2899113-01umb_inst
  • 2749179
  • (Sirsi) i9780470596920
Label
Integrated pharmaceutics : applied preformulation, product design, and regulatory science, Antoine Al-Achi, Mali Ram Gupta, William Craig Stagner
Publication
Bibliography note
Includes bibliographical references and index
Contents
  • Simple Linear Relationship
  • Non-Newtonian Systems
  • 7.4.
  • Viscoelasticity
  • 7.5.
  • Reynolds Number
  • 7.6.
  • Concluding Remarks
  • References
  • Glossary
  • ch. 8
  • 1.3.
  • Chemical Stability and Shelf-Life Determination
  • 8.1.
  • Introduction
  • 8.2.
  • Shelf-life Determination
  • 8.3.
  • Stability of Biotechnology Products
  • References
  • Glossary
  • ch. 9
  • Exponential Rules
  • Particle Science
  • 9.1.
  • Introduction
  • 9.2.
  • Particle Size Estimation and Distribution
  • 9.3.
  • Micronization
  • 9.4.
  • Particle Size Preparation and Reduction for Pulmonary Delivery
  • 9.5.
  • 1.4.
  • Polymeric Particulate Matter
  • 9.6.
  • Nanoparticles
  • 9.7.
  • Segregation of Particles
  • References
  • Glossary
  • ch. 10
  • Basic Statistics and Design of Experimental Concepts
  • 10.1.
  • Logarithmic Rules
  • Descriptive Statistics
  • 10.2.
  • Inferential Statistics
  • 10.3.
  • Statistical Applications in Quality Control Testing
  • 10.4.
  • Design of Experiment
  • References
  • Glossary
  • ch. 11
  • 1.5.
  • Formulation Development Concepts
  • 11.1.
  • Preformulation
  • 11.2.
  • Scale-up Considerations
  • 11.3.
  • Combination Products
  • 11.4.
  • Rate-Controlled Drug Delivery
  • 11.5.
  • Differential Equations
  • Drug Delivery Technologies for Improving Oral Delivery
  • 11.6.
  • Drug Delivery Technologies for Improving Transmucosal Delivery
  • 11.7.
  • Drug Delivery Technologies for Transdermal Delivery
  • 11.8.
  • Special Considerations for Biotechnology and Protein Delivery Systems
  • 11.9.
  • Drug-Excipient and Excipient-Excipient Interactions
  • 11.10.
  • 1.6.
  • Presence of Contaminants in a Formulation
  • 11.11.
  • Other Considerations
  • References
  • Glossary
  • pt. II
  • PRODUCT DESIGN
  • ch. 12
  • Product Design Process
  • 12.1.
  • Expanding and Reducing Formulas
  • Introduction
  • 12.2.
  • Formulation Design
  • 12.3.
  • Process Design
  • 12.4.
  • Container Closure System Design
  • References
  • Glossary
  • Appendixes
  • References
  • ch. 13
  • Tablet Product Design
  • 13.1.
  • Introduction
  • 13.2.
  • Formulation Design
  • 13.3.
  • Process Design
  • 13.4.
  • Container Closure System Design
  • Machine generated contents note:
  • Glossary
  • 13.5.
  • Risk Management
  • 13.6.
  • Attribute Tests
  • 13.7.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • ch. 14
  • ch. 2
  • Capsule Product Design
  • 14.1.
  • Introduction
  • 14.2.
  • Hard-Shell Capsules
  • 14.3.
  • Soft-Shell Capsules
  • 14.4.
  • Formulation and Process Optimization
  • 14.5.
  • Thermodynamics
  • Container Closure System
  • 14.6.
  • Risk Management
  • 14.7.
  • Attribute Tests
  • 14.8.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • 2.1.
  • ch. 15
  • Dispersed System Product Design
  • 15.1.
  • Introduction
  • 15.2.
  • Formulation Design
  • 15.3.
  • Process Design
  • 15.4.
  • Container Closure System Design
  • Introduction
  • 15.5.
  • Risk Management
  • 15.6.
  • Attribute Tests
  • 15.7.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • ch. 16
  • 2.2.
  • Aerosol Product Design
  • 16.1.
  • Introduction
  • 16.2.
  • Formulation Design
  • 16.3.
  • Container Closure System Design
  • 16.4.
  • Risk Management
  • 16.5.
  • Zeroth Law of Thermodynamics
  • Attribute Tests
  • 16.6.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendix
  • ch. 17
  • Sterile Injectable Product Design
  • 17.1.
  • Introduction
  • 2.3.
  • 17.2.
  • Formulation Design
  • 17.3.
  • Process Design
  • 17.4.
  • Container Closure System Design
  • 17.5.
  • Risk Management
  • 17.6.
  • Attribute Tests
  • First Law of Thermodynamics
  • 17.7.
  • New Drug Application Stability Assessment
  • References
  • Glossary
  • Appendixes
  • ch. 18
  • Ophthalmic Product Design
  • 18.1.
  • Introduction
  • 18.2.
  • 2.4.
  • Formulation Design
  • 18.3.
  • Process Design
  • 18.4.
  • Container Closure System Design
  • 18.5.
  • Attribute Tests
  • 18.6.
  • New Drug Application Stabilty Assessment
  • References
  • pt. I
  • Second Law of Thermodynamics
  • Glossary
  • Appendix
  • ch. 19
  • Transdermal Product Design
  • 19.1.
  • Introduction
  • 19.2.
  • Formulation Design
  • 19.3.
  • Conclusions
  • 2.5.
  • References
  • Glossary
  • Appendix
  • ch. 20
  • Oral Modified-Release Product Design
  • 20.1.
  • Introduction
  • 20.2.
  • Coatings
  • 20.3.
  • Third Law of Thermodynamics
  • Matrix Systems
  • 20.4.
  • Gastroretentive Devices
  • 20.5.
  • Osmotic Controlled Release Systems
  • 20.6.
  • Conclusions
  • References
  • Glossary
  • Appendix
  • 2.6.
  • pt. III
  • REGULATORY SCIENCE
  • ch. 21
  • Regulatory Practices and Guidelines
  • 21.1.
  • Worldwide Regulatory Agencies
  • 21.2.
  • Good Manufacturing Practice
  • 21.3.
  • FDA Inspection and Regulatory Actions
  • Polymorphism
  • References
  • Glossary
  • ch. 22
  • Regulations for Compounding Pharmacies
  • 22.1.
  • Introduction
  • 22.2.
  • Compounding Guidelines
  • 22.3.
  • FDA Compliance Policy Guides
  • 2.7.
  • 22.4.
  • Good Compounding Practices
  • 22.5.
  • Stability Criteria and Beyond-Use Dating of Compounded Preparations
  • 22.6.
  • Verification
  • 22.7.
  • Patient Counseling
  • 22.8.
  • Pharmacy Compounding Accreditation
  • Physical Stability of Crystal Forms
  • References
  • Glossary
  • Appendixes
  • ch. 23
  • IND and NDA Phase-Appropriate New Drug Development Process
  • 23.1.
  • Introduction
  • 23.2.
  • Preclinical Development Overview
  • 23.3.
  • 2.8.
  • Phase-Appropriate Clinical Trials Overview
  • 23.4.
  • Investigational New Drugs
  • 23.5.
  • NDA Review Process
  • References
  • Glossary
  • ch. 24
  • Generics, Biosimilars, and OTCS
  • 24.1.
  • Solubility
  • Generic Drugs
  • 24.2.
  • Biosimilar Drugs
  • 24.3.
  • Over-the-Counter Drugs
  • References
  • Glossary
  • Appendix
  • ch. 25
  • Accelerated New Drug Approval and Expedited Access of New Therapies
  • References
  • 25.1.
  • Introduction
  • 25.2.
  • Expedited Review and Approval of New Therapies
  • 25.3.
  • Expanded Access to New Therapies
  • 25.4.
  • Orphan Drugs
  • 25.5.
  • Pediatric Drugs
  • REFORMULATION
  • Glossary
  • 25.6.
  • Pediatric Drug Development and the Orphan Drug Act Incentives
  • 25.7.
  • Common EMEA/FDA Application for Orphan Medicinal Product Designation
  • References
  • Glossary
  • ch. 26
  • Post-Drug Approval Activities
  • 26.1.
  • Postmarket Requirements and Commitments
  • ch. 3
  • 26.2.
  • Postapproval Manufacturing Changes
  • 26.3.
  • Clinical Phase 4 Studies: Postmarketing Surveillance and Risk Assessment
  • 26.4.
  • Prescription Drug Advertising and Promotional Labeling Direct to Consumers
  • References
  • Glossary
  • Appendix
  • ch. 27
  • Solubility and Dissolution
  • Drug Master Files and EU Dossiers
  • 27.1.
  • Drug Master Files
  • 27.2.
  • European Marketing Authorization Dossiers
  • References
  • Glossary
  • ch. 28
  • Commissioning and Qualification
  • 28.1.
  • 3.1.
  • Regulatory Requirements
  • 28.2.
  • Preliminary C&Q Activities
  • 28.3.
  • Commissioning
  • 28.4.
  • Qualification and Validation
  • 28.5.
  • Qualification Protocols
  • 28.6.
  • Introduction
  • Process Validation
  • 28.7.
  • Cleaning Validation
  • 28.8.
  • Computer Systems Validation
  • 28.9.
  • Change Control
  • 28.10.
  • Revalidation
  • References
  • 3.2.
  • Glossary
  • ch. 29
  • Quality Systems and Controls
  • 29.1.
  • Pharmaceutical Quality System
  • 29.2.
  • Quality Systems Approach to CGMP Regulations
  • 29.3.
  • Inspection of Pharmaceutical Quality Control Laboratories
  • 29.4.
  • Concentration Units
  • Pharmacopeias
  • 29.5.
  • Analytical Instrument Qualification
  • 29.6.
  • Validation of Analytical Procedures
  • 29.7.
  • Stability Testing of New Drug Substances and Products
  • References
  • Glossary
  • Appendixes
  • 3.3.
  • ch. 30
  • Safety, Toxicology, and Pharmacogenomics
  • 30.1.
  • Nonclinical Safety Studies
  • 30.2.
  • Safety Pharmacology Studies
  • 30.3.
  • Carcinogenicity Studies of Pharmaceuticals
  • 30.4.
  • Genotoxicity Testing
  • What Should be Done When Alcohol is Prescribed in a Formulation
  • 30.5.
  • Immunotoxicity Studies
  • 30.6.
  • Safety Reporting Requirements
  • 30.7.
  • Pharmacogenomics
  • References
  • Glossary
  • Appendixes
  • ch. 31
  • 3.4.
  • Regulatory Science Initiatives for Advancing Public Health
  • 31.1.
  • Introduction
  • 31.2.
  • Advancing Regulatory Science for Public Health: The Promise of Regulatory Science
  • 31.3.
  • Advancing Regulatory Science at FDA: Strategic Plan for Regulatory Science
  • 31.4.
  • Collaborative Implementation Framework
  • References
  • ch. 1
  • Partition Coefficient
  • Glossary
  • 3.5.
  • Disintegration and Dissolution
  • 3.6.
  • Concluding Remarks
  • References
  • Glossary
  • ch. 4
  • Biological Aspects of Formulations
  • 4.1.
  • Mathematical Concepts
  • Introduction
  • 4.2.
  • Bioavailability and Bioequivalence
  • 4.3.
  • Protocols for Determining Bioequivalence
  • 4.4.
  • Bioequivalence Procedure
  • 4.5.
  • FDA-Approved Methods for Bioequivalence Studies
  • 4.6.
  • 1.1.
  • Approaches to Improving Bioavailability
  • References
  • Glossary
  • ch. 5
  • Interfacial Properties
  • 5.1.
  • Introduction
  • 5.2.
  • Liquid-Solid Interface
  • 5.3.
  • Introduction
  • Dosage-Form Applications
  • References
  • Glossary
  • ch. 6
  • Adsorption Phenomenon
  • 6.1.
  • Introduction
  • 6.2.
  • Adsorption on Filters
  • 6.3.
  • 1.2.
  • Adsorption of Proteins
  • References
  • Glossary
  • ch. 7
  • Rheological Principles
  • 7.1.
  • Introduction
  • 7.2.
  • Newtonian Systems
  • 7.3.
Dimensions
24 cm.
Extent
xix, 991 p.
Isbn
9780470596920
Isbn Type
(cloth)
Lccn
2012025748
Other physical details
ill.
System control number
  • (CaMWU)u2899113-01umb_inst
  • 2749179
  • (Sirsi) i9780470596920

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