The Resource Safety evaluation of pharmaceuticals and medical devices : international regulatory guidelines, Shayne C. Gad

Safety evaluation of pharmaceuticals and medical devices : international regulatory guidelines, Shayne C. Gad

Label
Safety evaluation of pharmaceuticals and medical devices : international regulatory guidelines
Title
Safety evaluation of pharmaceuticals and medical devices
Title remainder
international regulatory guidelines
Statement of responsibility
Shayne C. Gad
Creator
Subject
Language
eng
Cataloging source
DLC
http://library.link/vocab/creatorDate
1948-
http://library.link/vocab/creatorName
Gad, Shayne C.
Dewey number
615.1901
Illustrations
illustrations
Index
index present
LC call number
RS189
LC item number
.G33 2011
Literary form
non fiction
Nature of contents
bibliography
NLM call number
QV 771 ; WA 250
http://library.link/vocab/subjectName
  • Drugs
  • Medical instruments and apparatus
  • Pharmaceutical Preparations
  • Equipment and Supplies
  • Quality Control
Label
Safety evaluation of pharmaceuticals and medical devices : international regulatory guidelines, Shayne C. Gad
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Contents
  • Devices
  • References
  • Drugs: The General Case
  • IND/FIM Enabling
  • To Support Continued Clinical Development
  • To Support Marketing Approval
  • Subset: Special or Hazard Studies
  • ICH Requirements: The Global General Case
  • First Rule
  • References
  • Machine generated contents note:
  • IND-Enabling Toxicology Programs
  • Toxicity Testing: Traditional Pharmaceuticals
  • Common Mistakes
  • Toxicity Testing of Pharmaceuticals: The General Approach
  • Developmental and Reproductive Toxicity Studies
  • Genetic Toxicity Assessment
  • Safety Pharmacology Studies
  • Toxicity Testing: Biotechnology Products
  • Toxicology Testing: Special Cases
  • Oral Contraceptives
  • Global Pharmaceutical and Medical Device Markets
  • Life-Threatening Diseases (Compassionate Use)
  • Antibiotics and Anti-Infectives
  • Special Cases
  • Direct to FIM Trials: Imaging Agents
  • Gene Therapy
  • Cellular (Stem Cell) Therapy
  • Excipients
  • Pediatric Claims and Juvenile Animal Studies
  • Exploratory INDs
  • References
  • Legislative Considerations
  • Nonclinical Safety Evaluation Studies Conducted to Support Continued Clinical Development
  • Repeat Dose Toxicity
  • Developmental and Reproductive Toxicology (DART)
  • Impurities, Degradants, and Residual Solvents
  • Impurities
  • Residual Solvents
  • Extractables and Leachables
  • Residual Metals and Metal Catalysts
  • Safety Assessment of Metabolites (Metabolites in Safety Testing - MIST)
  • Local Tissue Tolerance
  • Regulations: Human Pharmaceuticals
  • Nonclinical Abuse Liability
  • Drug Registration in Japan
  • Drugs in China; Pharmacology and Toxicology Study Information
  • References
  • Supporting Marketing Applications
  • Non-Traditional (Other than NDA/505b (1) Approval Routes and Requirements
  • Carcinogenicity
  • Pre-and Post-natal Development
  • Pediatric Population Studies
  • Special Cases
  • Special Cases: Biologics and Combination Products
  • References
  • Special Therapeutic Category and Route of Administration Cases
  • Specific Therapeutic Classes
  • Oncology Drugs
  • Activity Profile and Mechanism of Action
  • Mechanism(s) of Resistance
  • Special Considerations for Biopharmaceutical Studies
  • Nonclinical Data Evaluation to Support Clinical Trial Design
  • Start Dose for First Administration in Human
  • Dose Escalation and the Highest Dose in a Clinical Trial
  • Strategies for Development
  • Duration and Schedule of Toxicology Studies to Support Initial Clinical Trials
  • Duration of Toxicology Studies to Support Continued Development
  • Combinations of Pharmaceuticals
  • Studies in Pediatric Populations
  • Special Considerations for Biologics
  • Conjugated Agents
  • Liposomal Formulated Products
  • Evaluation of Drug Metabolites
  • Evaluation of Impurities
  • Other Life-Threatening Chronic Diseases
  • Drugs
  • Imaging Agents
  • Antibiotics
  • Vaccines
  • Routes and Regimens Other than Oral and Daily
  • Combination Products
  • Historical Background
  • References
  • Device Safety Evaluation
  • Introduction
  • Regulatory Definition of Medical Devices
  • What You Need to Know to Start
  • International Standards Organization
  • Topical Devices
  • Blood Path Direct
  • Japan
  • Other Regulatory Guidances
  • Biological Tests
  • References
  • Appendices
Dimensions
24 cm.
Extent
xi, 126 p.
Isbn
9781441974488
Isbn Type
(hrd. : alk. paper)
Lccn
2010937640
Other physical details
ill. (some col.)
System control number
  • (CaMWU)u2429837-01umb_inst
  • 2478755
  • (Sirsi) i9781441974488
  • (OCoLC)692448825
Label
Safety evaluation of pharmaceuticals and medical devices : international regulatory guidelines, Shayne C. Gad
Publication
Bibliography note
Includes bibliographical references and index
Contents
  • Devices
  • References
  • Drugs: The General Case
  • IND/FIM Enabling
  • To Support Continued Clinical Development
  • To Support Marketing Approval
  • Subset: Special or Hazard Studies
  • ICH Requirements: The Global General Case
  • First Rule
  • References
  • Machine generated contents note:
  • IND-Enabling Toxicology Programs
  • Toxicity Testing: Traditional Pharmaceuticals
  • Common Mistakes
  • Toxicity Testing of Pharmaceuticals: The General Approach
  • Developmental and Reproductive Toxicity Studies
  • Genetic Toxicity Assessment
  • Safety Pharmacology Studies
  • Toxicity Testing: Biotechnology Products
  • Toxicology Testing: Special Cases
  • Oral Contraceptives
  • Global Pharmaceutical and Medical Device Markets
  • Life-Threatening Diseases (Compassionate Use)
  • Antibiotics and Anti-Infectives
  • Special Cases
  • Direct to FIM Trials: Imaging Agents
  • Gene Therapy
  • Cellular (Stem Cell) Therapy
  • Excipients
  • Pediatric Claims and Juvenile Animal Studies
  • Exploratory INDs
  • References
  • Legislative Considerations
  • Nonclinical Safety Evaluation Studies Conducted to Support Continued Clinical Development
  • Repeat Dose Toxicity
  • Developmental and Reproductive Toxicology (DART)
  • Impurities, Degradants, and Residual Solvents
  • Impurities
  • Residual Solvents
  • Extractables and Leachables
  • Residual Metals and Metal Catalysts
  • Safety Assessment of Metabolites (Metabolites in Safety Testing - MIST)
  • Local Tissue Tolerance
  • Regulations: Human Pharmaceuticals
  • Nonclinical Abuse Liability
  • Drug Registration in Japan
  • Drugs in China; Pharmacology and Toxicology Study Information
  • References
  • Supporting Marketing Applications
  • Non-Traditional (Other than NDA/505b (1) Approval Routes and Requirements
  • Carcinogenicity
  • Pre-and Post-natal Development
  • Pediatric Population Studies
  • Special Cases
  • Special Cases: Biologics and Combination Products
  • References
  • Special Therapeutic Category and Route of Administration Cases
  • Specific Therapeutic Classes
  • Oncology Drugs
  • Activity Profile and Mechanism of Action
  • Mechanism(s) of Resistance
  • Special Considerations for Biopharmaceutical Studies
  • Nonclinical Data Evaluation to Support Clinical Trial Design
  • Start Dose for First Administration in Human
  • Dose Escalation and the Highest Dose in a Clinical Trial
  • Strategies for Development
  • Duration and Schedule of Toxicology Studies to Support Initial Clinical Trials
  • Duration of Toxicology Studies to Support Continued Development
  • Combinations of Pharmaceuticals
  • Studies in Pediatric Populations
  • Special Considerations for Biologics
  • Conjugated Agents
  • Liposomal Formulated Products
  • Evaluation of Drug Metabolites
  • Evaluation of Impurities
  • Other Life-Threatening Chronic Diseases
  • Drugs
  • Imaging Agents
  • Antibiotics
  • Vaccines
  • Routes and Regimens Other than Oral and Daily
  • Combination Products
  • Historical Background
  • References
  • Device Safety Evaluation
  • Introduction
  • Regulatory Definition of Medical Devices
  • What You Need to Know to Start
  • International Standards Organization
  • Topical Devices
  • Blood Path Direct
  • Japan
  • Other Regulatory Guidances
  • Biological Tests
  • References
  • Appendices
Dimensions
24 cm.
Extent
xi, 126 p.
Isbn
9781441974488
Isbn Type
(hrd. : alk. paper)
Lccn
2010937640
Other physical details
ill. (some col.)
System control number
  • (CaMWU)u2429837-01umb_inst
  • 2478755
  • (Sirsi) i9781441974488
  • (OCoLC)692448825

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