The Resource Biotechnology operations : principles and practices, Michael J. Roy

Biotechnology operations : principles and practices, Michael J. Roy

Label
Biotechnology operations : principles and practices
Title
Biotechnology operations
Title remainder
principles and practices
Statement of responsibility
Michael J. Roy
Creator
Subject
Language
eng
Summary
"This book resulted from experiences gained working in biotechnology and while teaching a graduate course entitled Biotechnology Operations and offered to graduate students in the Master of Science (M.S.) in Biotechnology Program at the University of Wisconsin-Madison (http://www.ms-biotech.wisc.edu/ ). In this course we examine the undertaking of developing biotechnology products, focusing on the scientific and management skills of biomanufacturing, clinical trials, non-clinical studies, project management, quality assurance, quality control, and regulatory affairs. The course emphasizes both operational planning for success and integration of plans and efforts in these seven functional areas. The instructors realized from their experience in the biotechnology industry the great need to carefully plan and fully integrate biotechnology development projects. The course is taught in that manner and this book reflects that philosophy with the outcome is a practical guide for students and for those employed or interested in biotechnology"--Provided by publisher
Cataloging source
DNLM/DLC
http://library.link/vocab/creatorName
Roy, Michael Joseph
Dewey number
660.6
Illustrations
illustrations
Index
index present
LC call number
TP248.2
LC item number
.R69 2011
Literary form
non fiction
Nature of contents
bibliography
NLM call number
W 82
http://library.link/vocab/subjectName
  • Biotechnology
  • Biotechnology industries
  • Biotechnological process control
  • Project management
  • Biomedical Technology
  • Biotechnology
  • Planning Techniques
  • Program Development
  • Total Quality Management
Label
Biotechnology operations : principles and practices, Michael J. Roy
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Contents
  • Product Development Plan
  • Quality Systems
  • Overview of Quality in Biotechnology
  • History: Evolution of Quality Concepts and Practices
  • Quality Systems Approach to Product Development
  • Planning a Quality System
  • Defining Objectives and Ensuring Management Support
  • Quality Manual
  • Quality Plan
  • Hallmarks of Quality: Fundamental Criteria for Building Effective Quality Systems
  • Management Responsibility
  • Clinical Development Planning
  • Defined Quality System
  • Quality by Design and Design Control
  • Quality by Design
  • Design Control
  • Design Change
  • Contractor, Vendor and Consultant Control
  • Product Identification and Traceability
  • Process Control
  • Environmental Controls
  • Inspection or Testing (Quality Control)
  • Project Management Planning
  • Release of Material, Service or Product
  • Change Control and Corrective or Preventive Actions
  • Packaging and Labeling
  • Preservation, Storage and Handling
  • Servicing
  • Customer Concerns and Adverse Event Reports
  • Document Control
  • Training
  • Auditing
  • Quality Assurance Unit
  • Regulatory Planning
  • Manage the Quality Assurance Function
  • Control Documents and Manage the Documentation System
  • Investigate Situations: Manage and Control Change
  • Ensure Qualified and Trained Staff
  • Perform Audits
  • Initiate a Quality System for a Biotechnology Operation
  • Unique and Effective Approaches to Quality Management
  • Risk-Based Approaches to Quality Systems
  • Total Quality Management (TQM)
  • Six Sigma
  • Nonclinical Planning
  • Quality Systems for Research
  • Resolving Quality Issues or Problems
  • Summary of Quality Systems
  • 6.
  • Biomanufacture
  • Overview of Biomanufacturing Requirements
  • Design in Biomanufacture
  • Technical Considerations for Biomanufacture
  • Phases and Scale Up: The Biomanufacturing Life Cycle
  • Raw Material Considerations
  • Biomanufacturing Planning
  • Compliance and Quality in Biomanufacture: Current Good Manufacturing Practices
  • Biomanufacturing Processes for Biotechnology Products
  • Expression of Recombinant Proteins and Nucleic Acids
  • Production of Recombinant Molecules from Expression Vectors
  • Genes, Vectors and Host Cells
  • Bacterial Cell Expression Systems
  • Yeast Cell Expression Systems
  • Mammalian or Insect Cell Expression Systems
  • Production of Master Cell Banks and Working Cell Banks
  • Biomanufacture of Recombinant Proteins
  • Quality Control Planning
  • Planning Production of a Recombinant Protein
  • Upstream Process: Production by Bacterial or Yeast Cell Fermentation
  • Upstream Process: Production by Mammalian or Insect Cell Culture
  • Upstream Process: Recovery
  • Downstream Process: Purification
  • In-Process Testing and Analysis of Bulk Substance
  • Production of Bacterial Plasmid DNA
  • Production of Live Recombinant Organisms: Bacteria and Virus
  • Production of Products Composed of Mammalian Somatic Cells or Tissues
  • Production of Cellular Products Derived from Pluripotent (Stem) Cells
  • Quality Systems and Quality Assurance Planning
  • Production of Biological Molecules by Transgenic Animals or Transgenic Plants
  • Production of Biologically Active Lipids, Glycolipids and Complex Carbohydrates
  • Production of Biologically Active Peptides
  • Production of Combination Products: Biopharmaceutical with a Drug or Medical Device
  • Final Product: Formulation Fill, Finish and Labeling
  • Biomanufacturing Facilities, Utilities and Equipment
  • Facility Design Considerations
  • Facility and Utilities: A Controlled Environment
  • Operation of Clean Work Areas for Biomanufacture
  • Biomanufacturing Equipment
  • Additional Elements of Product Planning
  • Contract Manufacturing Options
  • Validation of Biomanufacturing Facilities, Utilities, Equipment and Processes
  • Summary of Biomanufacture
  • 7.
  • Quality Control
  • Quality Control Overview
  • Define Product Attributes
  • Analytical Methods Measure Attributes
  • Traits of Analytical Methods
  • Draft a Certificate of Analysis (Bulk Substance)
  • Summary of Planning for Success
  • Select Analytical Methods
  • Develop Specifications
  • Enter Test Results
  • Certificate of Analysis for Drug Product
  • In-Process Testing
  • Analytical Methods
  • Additional Analytical Tools and Concepts
  • Quality Control of Cell Banks
  • Samples and Sampling
  • Analytical Controls and Reference Standards
  • Machine generated contents note:
  • 2.
  • Test Failures, Out-of-Specification Results and Retesting
  • Testing for Product Stability
  • Quality Control Testing of Raw Materials
  • Quality Control and the Manufacturing Environment
  • Qualification, Validation and Verification of Analytical Methods
  • Assay Validation
  • Application of Statistics in Assay Performance and Validation
  • Summary of Quality Control
  • 8.
  • Nonclinical Studies
  • Project Management
  • Nonclinical Studies and Risk Assessment
  • Biopharmaceutical Delivery, Pharmacokinetics and Pharmacodynamics
  • Product Delivery to the Body
  • Absorption, Distribution, Elimination and Metabolism (ADME)
  • Absorption
  • Distribution
  • Metabolism and Biotransformation
  • Excretion
  • Pharmacokinetics and Pharmacodynamics
  • Application of Pharmacokinetics and Pharmacodynamics in Biopharmaceutical Development
  • Project Management in Biotechnology
  • Safety Assessment of Biopharmaceuticals
  • Toxicology
  • Design of a Safety Assessment Program
  • In Vitro Screens: Surrogate Measures of Toxicity
  • In Vivo Safety Testing of Biopharmaceuticals
  • Animal Model Development
  • Test Product Formulations, Routes of Delivery and Dosing Designs
  • Protocols and Performance of Biopharmaceutical Safety Studies in Animals
  • Elements of a Nonclinical Study Design
  • Acute Toxicity Testing
  • Background of Project Management
  • Subchronic and Chronic Toxicity Testing --
  • Project Management in Biotechnology
  • Project Management Environment
  • Project Objectives and Schedules
  • Sociotechnical Considerations
  • Participants in Project Management
  • Project Management in Biotechnology Operations
  • 1.
  • Establishing Project Management
  • Work Breakdown Structure
  • Forming a Project Team and Hands-On Project Management
  • Communication and Feedback
  • Team Dynamics
  • Project Risk Assessment and Management
  • Metrics and Tracking Progress
  • Resources: Planning and Usage
  • Human Factors in Project Management
  • Project Completion
  • Introduction to Biotechnology Operations: Planning for Success
  • Project Management with Contracts and Collaborations
  • Tools for Effective Project Management
  • Summary of Project Management in Biotechnology Development
  • 3.
  • Regulatory Affairs
  • U.S. Food and Drug Administration: Law and Regulations for Biopharmaceuticals
  • Historical Basis for FDA Regulation
  • Regulatory Organization of FDA
  • Food and Drug Law, Regulation and Guidance
  • FDA-Regulated Products
  • Biotechnology Operations
  • Biologics
  • Drugs
  • Medical Devices
  • Combination Products
  • Other Classes of Biotechnology Products and Their Review at the FDA
  • Products for Veterinary Use
  • Cosmetics, Food, Dietary Supplements, Homeopathic or Nutritional Products
  • U.S. FDA Regulatory Information and Resources: Regulatory Intelligence
  • Regulatory Operations for FDA Applications
  • Regulatory Planning and the Regulatory Environment
  • Marketing, Financial and Business Considerations for Development
  • Risk versus Benefit
  • Applications Seeking FDA Investigational Use or Marketing Approval
  • Investigational Use Applications: Investigational New Drug (IND) Application
  • Marketing Applications: Biologics License Application (BLA) and New Drug Application (NDA)
  • Medical Device Applications: 510(k) and Premarket Approval (PMA)
  • Special Documents, Pathways or Exemptions
  • Generic Drugs and Biosimiliar or Follow-On Biologics
  • Other Regulatory Activities
  • Public Meetings and Advisory Committees
  • Postmarketing Requirements and Activities
  • Product Development Planning
  • Advertising and Promotion
  • Summary on Regulatory Affairs Activities in Biotechnology Operations
  • 4.
  • Regulatory Compliance
  • Regulatory Compliance
  • Quality Systems to Meet Regulatory Compliance
  • Compliance and Quality Systems
  • cGMPs: Current Good Manufacturing Practices for Manufacture and Quality Control
  • cGLPs: Current Good Laboratory Practices for Nonclinical Lab Studies
  • cGCPs: Current Good Clinical Practices for Clinical Studies
  • Rationale for Product Development Planning
  • Compliance for Biopharmaceuticals: Other Regulations of Importance
  • Compliance for Import of Biopharmaceuticals into the United States
  • Compliance for Medical Devices
  • Inspection and Enforcement
  • Inspections
  • Enforcement Actions
  • Product Liability
  • Compliance with Non-FDA Regulations: International, National, State and Local
  • International and Foreign National Regulatory Authorities for Medical Biotechnology Products
  • Transporting Infectious or Otherwise Hazardous Materials
  • Targeted Product Profile
  • Importing, Possessing or Transferring Controlled Biotechnology Materials
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002
  • Importation or Exportation of Biotechnology Products for the Purpose of Treatment of Diseases in Man
  • Occupational Health and Safety
  • Environmental Regulations in Biotechnology
  • Genetically Modified Organisms or Molecules
  • U.S. Regulatory Agencies Unified Biotechnology Web Site
  • International Diligence in Biotechnology Operations
  • Summary of Non-FDA Compliance
  • 5.
  • 9.
  • Clinical Trials
  • Introduction to Clinical Trials
  • Background of Clinical Research
  • Introduction
  • Historical Information on Clinical Trials
  • Organization of Clinical Research
  • Phases of Clinical Trials
  • Science of Clinical Research
  • Quality in Clinical Research and Current Good Clinical Practices
  • Contents note continued:
  • Clinical Development Planning
  • Infrastructure for a Clinical Trial: Individuals, Documents and Investigational Product
  • Design of Clinical Trials and the Clinical Protocol
  • Human Subjects, Patients and Volunteers
  • Sponsor
  • Principal Investigator and His/Her Study Staff
  • Institutional Review Boards (IRB): Process of Informed Consent (IC) and IC Form
  • Investigational Product
  • Collection of Clinical Data: Case Report Forms and the Patient Diary
  • Clinical Testing Laboratories
  • Reproductive, Developmental and Teratogenicity Toxicity Testing
  • Reporting Results of Clinical Trials: Clinical Summary Reports
  • Clinical Trial Operations
  • Activities Leading to a Clinical Trial
  • Phase 1
  • Clinical Trial: First-Time-in-Man
  • Clinical Pharmacology Studies of Biopharmaceuticals in Man
  • Phase 2
  • Clinical Trial: Proof-of-Concept
  • Phase 3
  • Clinical Trial: Therapeutic Confirmatory
  • Carcinogenicity Testing
  • Phase 4
  • Clinical Study and REMS
  • Clinical Trials for New Populations or Indications
  • Global Clinical Trials
  • Quality Systems for Clinical Trials: Current Good Clinical Practices
  • Quality and cGCP in Clinical Trial Operations
  • Integrity of Clinical Study Data and Documents
  • Monitoring and Auditing Clinical Trials
  • Ethical Behavior and the Well-Being of Clinical Trial Subjects
  • Summary on Clinical Trials
  • Immunotoxicology
  • Genetic Toxicology
  • Tissue Binding or Local Tissue Tolerance
  • Quality of Nonclinical Studies: Current Good Laboratory Practices
  • Summary of Nonclinical Studies
Dimensions
25 cm.
Extent
xv, 415 p.
Isbn
9781439830277
Isbn Type
(hardcover : alkaline paper)
Lccn
2010048796
Other physical details
ill.
System control number
  • (CaMWU)u2206285-01umb_inst
  • 2352859
  • (Sirsi) i9781439830277
  • (OCoLC)682072228
Label
Biotechnology operations : principles and practices, Michael J. Roy
Publication
Bibliography note
Includes bibliographical references and index
Contents
  • Product Development Plan
  • Quality Systems
  • Overview of Quality in Biotechnology
  • History: Evolution of Quality Concepts and Practices
  • Quality Systems Approach to Product Development
  • Planning a Quality System
  • Defining Objectives and Ensuring Management Support
  • Quality Manual
  • Quality Plan
  • Hallmarks of Quality: Fundamental Criteria for Building Effective Quality Systems
  • Management Responsibility
  • Clinical Development Planning
  • Defined Quality System
  • Quality by Design and Design Control
  • Quality by Design
  • Design Control
  • Design Change
  • Contractor, Vendor and Consultant Control
  • Product Identification and Traceability
  • Process Control
  • Environmental Controls
  • Inspection or Testing (Quality Control)
  • Project Management Planning
  • Release of Material, Service or Product
  • Change Control and Corrective or Preventive Actions
  • Packaging and Labeling
  • Preservation, Storage and Handling
  • Servicing
  • Customer Concerns and Adverse Event Reports
  • Document Control
  • Training
  • Auditing
  • Quality Assurance Unit
  • Regulatory Planning
  • Manage the Quality Assurance Function
  • Control Documents and Manage the Documentation System
  • Investigate Situations: Manage and Control Change
  • Ensure Qualified and Trained Staff
  • Perform Audits
  • Initiate a Quality System for a Biotechnology Operation
  • Unique and Effective Approaches to Quality Management
  • Risk-Based Approaches to Quality Systems
  • Total Quality Management (TQM)
  • Six Sigma
  • Nonclinical Planning
  • Quality Systems for Research
  • Resolving Quality Issues or Problems
  • Summary of Quality Systems
  • 6.
  • Biomanufacture
  • Overview of Biomanufacturing Requirements
  • Design in Biomanufacture
  • Technical Considerations for Biomanufacture
  • Phases and Scale Up: The Biomanufacturing Life Cycle
  • Raw Material Considerations
  • Biomanufacturing Planning
  • Compliance and Quality in Biomanufacture: Current Good Manufacturing Practices
  • Biomanufacturing Processes for Biotechnology Products
  • Expression of Recombinant Proteins and Nucleic Acids
  • Production of Recombinant Molecules from Expression Vectors
  • Genes, Vectors and Host Cells
  • Bacterial Cell Expression Systems
  • Yeast Cell Expression Systems
  • Mammalian or Insect Cell Expression Systems
  • Production of Master Cell Banks and Working Cell Banks
  • Biomanufacture of Recombinant Proteins
  • Quality Control Planning
  • Planning Production of a Recombinant Protein
  • Upstream Process: Production by Bacterial or Yeast Cell Fermentation
  • Upstream Process: Production by Mammalian or Insect Cell Culture
  • Upstream Process: Recovery
  • Downstream Process: Purification
  • In-Process Testing and Analysis of Bulk Substance
  • Production of Bacterial Plasmid DNA
  • Production of Live Recombinant Organisms: Bacteria and Virus
  • Production of Products Composed of Mammalian Somatic Cells or Tissues
  • Production of Cellular Products Derived from Pluripotent (Stem) Cells
  • Quality Systems and Quality Assurance Planning
  • Production of Biological Molecules by Transgenic Animals or Transgenic Plants
  • Production of Biologically Active Lipids, Glycolipids and Complex Carbohydrates
  • Production of Biologically Active Peptides
  • Production of Combination Products: Biopharmaceutical with a Drug or Medical Device
  • Final Product: Formulation Fill, Finish and Labeling
  • Biomanufacturing Facilities, Utilities and Equipment
  • Facility Design Considerations
  • Facility and Utilities: A Controlled Environment
  • Operation of Clean Work Areas for Biomanufacture
  • Biomanufacturing Equipment
  • Additional Elements of Product Planning
  • Contract Manufacturing Options
  • Validation of Biomanufacturing Facilities, Utilities, Equipment and Processes
  • Summary of Biomanufacture
  • 7.
  • Quality Control
  • Quality Control Overview
  • Define Product Attributes
  • Analytical Methods Measure Attributes
  • Traits of Analytical Methods
  • Draft a Certificate of Analysis (Bulk Substance)
  • Summary of Planning for Success
  • Select Analytical Methods
  • Develop Specifications
  • Enter Test Results
  • Certificate of Analysis for Drug Product
  • In-Process Testing
  • Analytical Methods
  • Additional Analytical Tools and Concepts
  • Quality Control of Cell Banks
  • Samples and Sampling
  • Analytical Controls and Reference Standards
  • Machine generated contents note:
  • 2.
  • Test Failures, Out-of-Specification Results and Retesting
  • Testing for Product Stability
  • Quality Control Testing of Raw Materials
  • Quality Control and the Manufacturing Environment
  • Qualification, Validation and Verification of Analytical Methods
  • Assay Validation
  • Application of Statistics in Assay Performance and Validation
  • Summary of Quality Control
  • 8.
  • Nonclinical Studies
  • Project Management
  • Nonclinical Studies and Risk Assessment
  • Biopharmaceutical Delivery, Pharmacokinetics and Pharmacodynamics
  • Product Delivery to the Body
  • Absorption, Distribution, Elimination and Metabolism (ADME)
  • Absorption
  • Distribution
  • Metabolism and Biotransformation
  • Excretion
  • Pharmacokinetics and Pharmacodynamics
  • Application of Pharmacokinetics and Pharmacodynamics in Biopharmaceutical Development
  • Project Management in Biotechnology
  • Safety Assessment of Biopharmaceuticals
  • Toxicology
  • Design of a Safety Assessment Program
  • In Vitro Screens: Surrogate Measures of Toxicity
  • In Vivo Safety Testing of Biopharmaceuticals
  • Animal Model Development
  • Test Product Formulations, Routes of Delivery and Dosing Designs
  • Protocols and Performance of Biopharmaceutical Safety Studies in Animals
  • Elements of a Nonclinical Study Design
  • Acute Toxicity Testing
  • Background of Project Management
  • Subchronic and Chronic Toxicity Testing --
  • Project Management in Biotechnology
  • Project Management Environment
  • Project Objectives and Schedules
  • Sociotechnical Considerations
  • Participants in Project Management
  • Project Management in Biotechnology Operations
  • 1.
  • Establishing Project Management
  • Work Breakdown Structure
  • Forming a Project Team and Hands-On Project Management
  • Communication and Feedback
  • Team Dynamics
  • Project Risk Assessment and Management
  • Metrics and Tracking Progress
  • Resources: Planning and Usage
  • Human Factors in Project Management
  • Project Completion
  • Introduction to Biotechnology Operations: Planning for Success
  • Project Management with Contracts and Collaborations
  • Tools for Effective Project Management
  • Summary of Project Management in Biotechnology Development
  • 3.
  • Regulatory Affairs
  • U.S. Food and Drug Administration: Law and Regulations for Biopharmaceuticals
  • Historical Basis for FDA Regulation
  • Regulatory Organization of FDA
  • Food and Drug Law, Regulation and Guidance
  • FDA-Regulated Products
  • Biotechnology Operations
  • Biologics
  • Drugs
  • Medical Devices
  • Combination Products
  • Other Classes of Biotechnology Products and Their Review at the FDA
  • Products for Veterinary Use
  • Cosmetics, Food, Dietary Supplements, Homeopathic or Nutritional Products
  • U.S. FDA Regulatory Information and Resources: Regulatory Intelligence
  • Regulatory Operations for FDA Applications
  • Regulatory Planning and the Regulatory Environment
  • Marketing, Financial and Business Considerations for Development
  • Risk versus Benefit
  • Applications Seeking FDA Investigational Use or Marketing Approval
  • Investigational Use Applications: Investigational New Drug (IND) Application
  • Marketing Applications: Biologics License Application (BLA) and New Drug Application (NDA)
  • Medical Device Applications: 510(k) and Premarket Approval (PMA)
  • Special Documents, Pathways or Exemptions
  • Generic Drugs and Biosimiliar or Follow-On Biologics
  • Other Regulatory Activities
  • Public Meetings and Advisory Committees
  • Postmarketing Requirements and Activities
  • Product Development Planning
  • Advertising and Promotion
  • Summary on Regulatory Affairs Activities in Biotechnology Operations
  • 4.
  • Regulatory Compliance
  • Regulatory Compliance
  • Quality Systems to Meet Regulatory Compliance
  • Compliance and Quality Systems
  • cGMPs: Current Good Manufacturing Practices for Manufacture and Quality Control
  • cGLPs: Current Good Laboratory Practices for Nonclinical Lab Studies
  • cGCPs: Current Good Clinical Practices for Clinical Studies
  • Rationale for Product Development Planning
  • Compliance for Biopharmaceuticals: Other Regulations of Importance
  • Compliance for Import of Biopharmaceuticals into the United States
  • Compliance for Medical Devices
  • Inspection and Enforcement
  • Inspections
  • Enforcement Actions
  • Product Liability
  • Compliance with Non-FDA Regulations: International, National, State and Local
  • International and Foreign National Regulatory Authorities for Medical Biotechnology Products
  • Transporting Infectious or Otherwise Hazardous Materials
  • Targeted Product Profile
  • Importing, Possessing or Transferring Controlled Biotechnology Materials
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002
  • Importation or Exportation of Biotechnology Products for the Purpose of Treatment of Diseases in Man
  • Occupational Health and Safety
  • Environmental Regulations in Biotechnology
  • Genetically Modified Organisms or Molecules
  • U.S. Regulatory Agencies Unified Biotechnology Web Site
  • International Diligence in Biotechnology Operations
  • Summary of Non-FDA Compliance
  • 5.
  • 9.
  • Clinical Trials
  • Introduction to Clinical Trials
  • Background of Clinical Research
  • Introduction
  • Historical Information on Clinical Trials
  • Organization of Clinical Research
  • Phases of Clinical Trials
  • Science of Clinical Research
  • Quality in Clinical Research and Current Good Clinical Practices
  • Contents note continued:
  • Clinical Development Planning
  • Infrastructure for a Clinical Trial: Individuals, Documents and Investigational Product
  • Design of Clinical Trials and the Clinical Protocol
  • Human Subjects, Patients and Volunteers
  • Sponsor
  • Principal Investigator and His/Her Study Staff
  • Institutional Review Boards (IRB): Process of Informed Consent (IC) and IC Form
  • Investigational Product
  • Collection of Clinical Data: Case Report Forms and the Patient Diary
  • Clinical Testing Laboratories
  • Reproductive, Developmental and Teratogenicity Toxicity Testing
  • Reporting Results of Clinical Trials: Clinical Summary Reports
  • Clinical Trial Operations
  • Activities Leading to a Clinical Trial
  • Phase 1
  • Clinical Trial: First-Time-in-Man
  • Clinical Pharmacology Studies of Biopharmaceuticals in Man
  • Phase 2
  • Clinical Trial: Proof-of-Concept
  • Phase 3
  • Clinical Trial: Therapeutic Confirmatory
  • Carcinogenicity Testing
  • Phase 4
  • Clinical Study and REMS
  • Clinical Trials for New Populations or Indications
  • Global Clinical Trials
  • Quality Systems for Clinical Trials: Current Good Clinical Practices
  • Quality and cGCP in Clinical Trial Operations
  • Integrity of Clinical Study Data and Documents
  • Monitoring and Auditing Clinical Trials
  • Ethical Behavior and the Well-Being of Clinical Trial Subjects
  • Summary on Clinical Trials
  • Immunotoxicology
  • Genetic Toxicology
  • Tissue Binding or Local Tissue Tolerance
  • Quality of Nonclinical Studies: Current Good Laboratory Practices
  • Summary of Nonclinical Studies
Dimensions
25 cm.
Extent
xv, 415 p.
Isbn
9781439830277
Isbn Type
(hardcover : alkaline paper)
Lccn
2010048796
Other physical details
ill.
System control number
  • (CaMWU)u2206285-01umb_inst
  • 2352859
  • (Sirsi) i9781439830277
  • (OCoLC)682072228

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