Nonclinical Safety Assessment
A Guide to International Pharmaceutical Regulations
Herausgegeben von Brock, William J.; Hastings, Kenneth L.; McGown, Kathy M.
Nonclinical Safety Assessment
A Guide to International Pharmaceutical Regulations
Herausgegeben von Brock, William J.; Hastings, Kenneth L.; McGown, Kathy M.
- Gebundenes Buch
- Merkliste
- Auf die Merkliste
- Bewerten Bewerten
- Teilen
- Produkt teilen
- Produkterinnerung
- Produkterinnerung
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical…mehr
- Predictive Approaches in Drug Discovery and Development175,99 €
- Pediatric Nonclinical Drug Testing140,99 €
- Drug Development203,99 €
- Jianling WangPredictive Admet177,99 €
- Jie-Jack LiDrug Discovery151,99 €
- Sandy WeinbergRegulatory Compliance132,99 €
- Zoran RankovicLead Generation Approaches in Drug Discovery139,99 €
-
-
-
It includes:
ICH - the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia
Repeated dose toxicity studies
Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology
Biotechnology-derived pharmaceuticals
Vaccine development
Phototoxicity and photocarcinogenicity
Degradants, impurities, excipients and metabolites
Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
- Produktdetails
- Verlag: Wiley & Sons
- Artikelnr. des Verlages: 14574591000
- 1. Auflage
- Seitenzahl: 488
- Erscheinungstermin: 29. April 2013
- Englisch
- Abmessung: 251mm x 172mm x 32mm
- Gewicht: 879g
- ISBN-13: 9780470745915
- ISBN-10: 0470745916
- Artikelnr.: 35710101
- Verlag: Wiley & Sons
- Artikelnr. des Verlages: 14574591000
- 1. Auflage
- Seitenzahl: 488
- Erscheinungstermin: 29. April 2013
- Englisch
- Abmessung: 251mm x 172mm x 32mm
- Gewicht: 879g
- ISBN-13: 9780470745915
- ISBN-10: 0470745916
- Artikelnr.: 35710101
Nonclinical Studies for Pharmaceuticals 1 1 Introduction 3 Kathy M. McGown
and William J. Brock 1.1 The Global Pharmaceutical Market 6 1.2 Looking to
the Future 9 1.3 Legal and Regulatory Considerations in Drug Development 10
1.4 The Drug Development Process - General Considerations 12 2 ICH: History
and Nonclinical Guidances 17 Jan-Willem van der Laan and Kenneth L.
Hastings 2.1 Introduction 17 2.2 Organization of the ICH 19 2.3 The ICH
Process 20 2.4 Animal Welfare and Alternative Methods 22 2.5 ICH M3 23 2.6
New Initiatives and Topics 24 3 Food and Drug Administration: Nonclinical
Program and Pharmaceutical Approval 27 William J. Brock and Kenneth L.
Hastings 3.1 Legislative Authority of the FDA 27 3.2 Nonclinical Drug
Development and the FDA 31 3.3 Nonclinical Testing: General Conditions and
Considerations 34 3.4 Toxicity Testing: Small Molecules and Traditional
Pharmaceuticals 34 3.5 Toxicity Testing of Pharmaceuticals - The General
Approach 35 3.6 First-in-Human Dosing: Results from Nonclinical Studies 37
4 Nonclinical Pharmaceutical Development in MERCOSUR and Brazil 41
Cristiana Leslie Corr^ea, Giuliana Selmi, and Flavio Ailton Duque Zambrone
4.1 Introduction 41 4.2 MERCOSUR 41 4.3 Brazil 44 5 Nonclinical Safety
Assessment: Canada 57 Jamie L. Doran and Mark T. Goldberg 5.1 Introduction
57 5.2 Organization of Health Canada 58 5.3 The Regulatory Framework for
Drug Approval in Canada 60 5.4 Nonclinical Assessment in Canada 64 5.5
Clinical Trial Applications 70 5.6 Special Regulatory Considerations 74 6
European Pharmaceutical Regulation - Nonclinical Testing Requirements 79
Adam Woolley and Jan Willem van der Laan 6.1 Introduction 79 6.2.1 Overview
82 6.3 Nonclinical Testing in the Support of Clinical Trials 86 6.4
Overview 96 7 South Africa 99 Fariza Feraoun and Malik Feraoun 7.1
Introduction 99 7.2 Country Information 100 7.3 The Regulatory Aspects 101
7.4 The Nonclinical Safety Assessment 109 7.5 Conclusion 114 8 Asia
Pacific: China 117 Lijie Fu and Qingli Wang 8.1 Introduction 117 8.2
History of Drug Administration 118 8.3 The Provisions for Drug Registration
122 8.4 The SFDA 123 8.5 The SFDA Affiliated Organizations 123 8.6 General
Registration Procedures 125 8.7 Pharmaceutical Application 125 8.8 Import
Drug Application 127 8.9 Testing Guidelines and Safety Evaluation 129 8.10
GLP Compliance in China 131 8.11 Animal Welfare Requirements 133 9
Pharmaceutical Regulations for Nonclinical Safety Assessment in Japan 135
Kazuichi Nakamura and Osamu Fueki 9.1 History of Regulation for Nonclinical
Safety Assessment in Japan 135 9.2 Approval Application of New Drugs in
Japan 136 9.3 Current Nonclinical Safety Guidelines Available in Japan 139
9.4 Current Trends of Conduct of Nonclinical Safety Evaluation in Japan 139
9.5 Safety Assessment of Unapproved Drugs 142 9.6 Necessity of 3Rs
(Reduction/Refinement/Replacement) of Animal Studies 142 9.7 Attitude of
Japanese Pharmaceutical Companies and the Regulatory Agency toward
Nonclinical Safety Assessment 142 10 Indian Regulatory Process for
Nonclinical Drug Development 145 K.S. Rao and S. Natesan 10.1 Introduction
145 10.2 Drug Development 146 10.3 Quality Systems 147 10.4 Nonclinical
Drug Development - Key Regulatory Requirements 148 10.5 Nonclinical Safety
Assessment - Key Approval Requirements 149 10.6 Data Required for Clinical
Study Approval 151 10.7 Animal Toxicology 154 10.8 Animal Pharmacology 166
10.9 Safety Assessment Requirements: Indian Schedule Yand International
Guidelines 168 10.10 Good Laboratory Practice Quality System in India 168
10.11 Safety Assessment Test Facilities in India 171 10.12 Investigational
New Drug Application for Undertaking Clinical Trials 173 11 Asia Pacific:
Australia 175 Douglas Francis 11.1 Introduction 175 11.2 Australian
Therapeutic Goods Administration (TGA) 176 11.3 Clinical Trials in
Australia 183 11.4 Nonclinical Data to Support the Conduct of Clinical
Trials in Australia and Marketing Application to the TGA 188 Part II
Toxicology Studies Supporting Clinical Development 197 12 Repeated-Dose
Toxicity Studies in Nonclinical Drug Development 199 Shana Azri-Meehan and
Louise Latriano 12.1 Introduction 199 12.2 General Considerations 200 12.3
Study Design Considerations 205 12.4 Study Observations and Assessments 211
13 Evaluation of Potential Carcinogenicity 219 James A. Popp and Matthew S.
Bogdanffy 13.1 Introduction 219 13.2 Preparation for the Carcinogenicity
Study 223 13.3 Elements of the Protocol/Study Plan 228 13.4 Study
Performance 241 13.5 Alternative Models to Evaluate Potential
Carcinogenicity in Lieu of a 2-Year Mouse Study 244 13.6 Special
Consideration for Carcinogenicity Evaluation of Biotherapeutics 247 13.7
Regulatory Implications of a Study Identifying an Animal Carcinogenic
Response 248 13.8 Interpreting the Relevance of Positive Results for Human
Safety 249 13.9 Communicating the Results in the Product Label 251 14
Genetic Toxicology 255 Mark W. Powley 14.1 Background 255 14.2 Regulations
Guiding Drug Development 256 14.3 Genotoxic Impurities 261 14.4 Regulatory
Decision Making 263 15 Developmental and Reproductive Toxicology 265 Robert
M. Parker and Raymond G. York 15.1 Introduction 265 15.2 Standard
Reproduction and Developmental Toxicity Study Designs 266 15.3 Timing of
Preclinical Developmental and Reproductive Toxicity Studies 273 15.4 Based
on Disease Indication 275 15.5 Based on Pharmaceutical Characteristic 279
15.6 Other Reasons to Conduct Preclinical Reproductive and Developmental
Toxicity Studies 291 15.7 Excipients 293 15.8 Conclusion 293 16 Juvenile
Animal Toxicity Studies: Regulatory Expectations, Decision Strategies and
Role in Paediatric Drug Development 297 Melissa S. Tassinari, Luc M. De
Schaepdrijver, and Mark E. Hurtt 16.1 Introduction 297 16.2 Regulatory
Environment 298 16.3 Relevance and Place in Drug Development 302 16.4
Strategies for Decision Making: When are Studies Needed and Appropriate?
304 16.5 Case Studies: Application of Data Review and Decision Making 307
16.6 Summary 309 17 Immunotoxicology 313 Leigh Ann Burns-Naas and Marc J.
Pallardy 17.1 Introduction 313 17.2 Regulatory Expectations for the
Immunotoxicology Evaluation of Pharmaceuticals 314 17.3 Special
Considerations 335 17.4 Summary 342 References 342 18 Nonclinical Safety
Assessment: Biotechnology-Derived Pharmaceuticals 347 Christopher E. Ellis,
Melanie T. Hartsough, Martin D. Green, and Hanan Ghantous 18.1 Introduction
347 18.2 Unique Characteristics of Biopharmaceuticals 348 18.3 Species
Selection 349 18.4 Immunogenicity 356 18.5 Biological
Activity/Pharmacodynamics 358 18.6 Pharmacokinetics/Toxicokinetics 359 18.7
Nonclinical Safety Assessment 362 18.8 Tissue Cross-Reactivity (TCR) 371
18.9 Clinical Starting Dose Selection for Biopharmaceuticals 373 18.10
Comparability 375 19 International Safety Regulations for Vaccine
Development 381 Robert V. House 19.1 Introduction 381 19.2 What
"Toxicities" have been Attributed to Vaccination? 381 19.3 How Vaccines are
(Slightly) Different from Other Biopharmaceuticals 383 19.4 Regulatory
Framework for Assessing Safety of Vaccines 383 19.5 Parameters Monitored
387 19.6 Clinical Safety Assessment of Vaccines 389 19.7 Summary 390 20
Phototoxicity and Photocarcinogenicity 393 Robert E. Osterberg, Christopher
P. Sambuco, and Paul Donald Forbes 20.1 History of Phototoxicity,
Photocarcinogenicity and Photogenotoxicity Testing at the US Food and Drug
Administration (FDA) 393 20.2 FDA Photosafety Testing Guidance 397 20.3
Status of In Vivo Testing for Photocarcinogenesis 417 20.4
Photocarcinogenesis Study Designs 418 20.5 Photo Co-Carcinogenesis 418 20.6
Future Testing Concepts, with Emphasis on Biomarkers 423 21 Degradants,
Impurities, Excipients and Metabolites 431 Robert E. Osterberg and Mark W.
Powley 21.1 Degradants, Impurities, and Excipients 431 21.2 Metabolites 442
References 446 Index 449
Nonclinical Studies for Pharmaceuticals 1 1 Introduction 3 Kathy M. McGown
and William J. Brock 1.1 The Global Pharmaceutical Market 6 1.2 Looking to
the Future 9 1.3 Legal and Regulatory Considerations in Drug Development 10
1.4 The Drug Development Process - General Considerations 12 2 ICH: History
and Nonclinical Guidances 17 Jan-Willem van der Laan and Kenneth L.
Hastings 2.1 Introduction 17 2.2 Organization of the ICH 19 2.3 The ICH
Process 20 2.4 Animal Welfare and Alternative Methods 22 2.5 ICH M3 23 2.6
New Initiatives and Topics 24 3 Food and Drug Administration: Nonclinical
Program and Pharmaceutical Approval 27 William J. Brock and Kenneth L.
Hastings 3.1 Legislative Authority of the FDA 27 3.2 Nonclinical Drug
Development and the FDA 31 3.3 Nonclinical Testing: General Conditions and
Considerations 34 3.4 Toxicity Testing: Small Molecules and Traditional
Pharmaceuticals 34 3.5 Toxicity Testing of Pharmaceuticals - The General
Approach 35 3.6 First-in-Human Dosing: Results from Nonclinical Studies 37
4 Nonclinical Pharmaceutical Development in MERCOSUR and Brazil 41
Cristiana Leslie Corr^ea, Giuliana Selmi, and Flavio Ailton Duque Zambrone
4.1 Introduction 41 4.2 MERCOSUR 41 4.3 Brazil 44 5 Nonclinical Safety
Assessment: Canada 57 Jamie L. Doran and Mark T. Goldberg 5.1 Introduction
57 5.2 Organization of Health Canada 58 5.3 The Regulatory Framework for
Drug Approval in Canada 60 5.4 Nonclinical Assessment in Canada 64 5.5
Clinical Trial Applications 70 5.6 Special Regulatory Considerations 74 6
European Pharmaceutical Regulation - Nonclinical Testing Requirements 79
Adam Woolley and Jan Willem van der Laan 6.1 Introduction 79 6.2.1 Overview
82 6.3 Nonclinical Testing in the Support of Clinical Trials 86 6.4
Overview 96 7 South Africa 99 Fariza Feraoun and Malik Feraoun 7.1
Introduction 99 7.2 Country Information 100 7.3 The Regulatory Aspects 101
7.4 The Nonclinical Safety Assessment 109 7.5 Conclusion 114 8 Asia
Pacific: China 117 Lijie Fu and Qingli Wang 8.1 Introduction 117 8.2
History of Drug Administration 118 8.3 The Provisions for Drug Registration
122 8.4 The SFDA 123 8.5 The SFDA Affiliated Organizations 123 8.6 General
Registration Procedures 125 8.7 Pharmaceutical Application 125 8.8 Import
Drug Application 127 8.9 Testing Guidelines and Safety Evaluation 129 8.10
GLP Compliance in China 131 8.11 Animal Welfare Requirements 133 9
Pharmaceutical Regulations for Nonclinical Safety Assessment in Japan 135
Kazuichi Nakamura and Osamu Fueki 9.1 History of Regulation for Nonclinical
Safety Assessment in Japan 135 9.2 Approval Application of New Drugs in
Japan 136 9.3 Current Nonclinical Safety Guidelines Available in Japan 139
9.4 Current Trends of Conduct of Nonclinical Safety Evaluation in Japan 139
9.5 Safety Assessment of Unapproved Drugs 142 9.6 Necessity of 3Rs
(Reduction/Refinement/Replacement) of Animal Studies 142 9.7 Attitude of
Japanese Pharmaceutical Companies and the Regulatory Agency toward
Nonclinical Safety Assessment 142 10 Indian Regulatory Process for
Nonclinical Drug Development 145 K.S. Rao and S. Natesan 10.1 Introduction
145 10.2 Drug Development 146 10.3 Quality Systems 147 10.4 Nonclinical
Drug Development - Key Regulatory Requirements 148 10.5 Nonclinical Safety
Assessment - Key Approval Requirements 149 10.6 Data Required for Clinical
Study Approval 151 10.7 Animal Toxicology 154 10.8 Animal Pharmacology 166
10.9 Safety Assessment Requirements: Indian Schedule Yand International
Guidelines 168 10.10 Good Laboratory Practice Quality System in India 168
10.11 Safety Assessment Test Facilities in India 171 10.12 Investigational
New Drug Application for Undertaking Clinical Trials 173 11 Asia Pacific:
Australia 175 Douglas Francis 11.1 Introduction 175 11.2 Australian
Therapeutic Goods Administration (TGA) 176 11.3 Clinical Trials in
Australia 183 11.4 Nonclinical Data to Support the Conduct of Clinical
Trials in Australia and Marketing Application to the TGA 188 Part II
Toxicology Studies Supporting Clinical Development 197 12 Repeated-Dose
Toxicity Studies in Nonclinical Drug Development 199 Shana Azri-Meehan and
Louise Latriano 12.1 Introduction 199 12.2 General Considerations 200 12.3
Study Design Considerations 205 12.4 Study Observations and Assessments 211
13 Evaluation of Potential Carcinogenicity 219 James A. Popp and Matthew S.
Bogdanffy 13.1 Introduction 219 13.2 Preparation for the Carcinogenicity
Study 223 13.3 Elements of the Protocol/Study Plan 228 13.4 Study
Performance 241 13.5 Alternative Models to Evaluate Potential
Carcinogenicity in Lieu of a 2-Year Mouse Study 244 13.6 Special
Consideration for Carcinogenicity Evaluation of Biotherapeutics 247 13.7
Regulatory Implications of a Study Identifying an Animal Carcinogenic
Response 248 13.8 Interpreting the Relevance of Positive Results for Human
Safety 249 13.9 Communicating the Results in the Product Label 251 14
Genetic Toxicology 255 Mark W. Powley 14.1 Background 255 14.2 Regulations
Guiding Drug Development 256 14.3 Genotoxic Impurities 261 14.4 Regulatory
Decision Making 263 15 Developmental and Reproductive Toxicology 265 Robert
M. Parker and Raymond G. York 15.1 Introduction 265 15.2 Standard
Reproduction and Developmental Toxicity Study Designs 266 15.3 Timing of
Preclinical Developmental and Reproductive Toxicity Studies 273 15.4 Based
on Disease Indication 275 15.5 Based on Pharmaceutical Characteristic 279
15.6 Other Reasons to Conduct Preclinical Reproductive and Developmental
Toxicity Studies 291 15.7 Excipients 293 15.8 Conclusion 293 16 Juvenile
Animal Toxicity Studies: Regulatory Expectations, Decision Strategies and
Role in Paediatric Drug Development 297 Melissa S. Tassinari, Luc M. De
Schaepdrijver, and Mark E. Hurtt 16.1 Introduction 297 16.2 Regulatory
Environment 298 16.3 Relevance and Place in Drug Development 302 16.4
Strategies for Decision Making: When are Studies Needed and Appropriate?
304 16.5 Case Studies: Application of Data Review and Decision Making 307
16.6 Summary 309 17 Immunotoxicology 313 Leigh Ann Burns-Naas and Marc J.
Pallardy 17.1 Introduction 313 17.2 Regulatory Expectations for the
Immunotoxicology Evaluation of Pharmaceuticals 314 17.3 Special
Considerations 335 17.4 Summary 342 References 342 18 Nonclinical Safety
Assessment: Biotechnology-Derived Pharmaceuticals 347 Christopher E. Ellis,
Melanie T. Hartsough, Martin D. Green, and Hanan Ghantous 18.1 Introduction
347 18.2 Unique Characteristics of Biopharmaceuticals 348 18.3 Species
Selection 349 18.4 Immunogenicity 356 18.5 Biological
Activity/Pharmacodynamics 358 18.6 Pharmacokinetics/Toxicokinetics 359 18.7
Nonclinical Safety Assessment 362 18.8 Tissue Cross-Reactivity (TCR) 371
18.9 Clinical Starting Dose Selection for Biopharmaceuticals 373 18.10
Comparability 375 19 International Safety Regulations for Vaccine
Development 381 Robert V. House 19.1 Introduction 381 19.2 What
"Toxicities" have been Attributed to Vaccination? 381 19.3 How Vaccines are
(Slightly) Different from Other Biopharmaceuticals 383 19.4 Regulatory
Framework for Assessing Safety of Vaccines 383 19.5 Parameters Monitored
387 19.6 Clinical Safety Assessment of Vaccines 389 19.7 Summary 390 20
Phototoxicity and Photocarcinogenicity 393 Robert E. Osterberg, Christopher
P. Sambuco, and Paul Donald Forbes 20.1 History of Phototoxicity,
Photocarcinogenicity and Photogenotoxicity Testing at the US Food and Drug
Administration (FDA) 393 20.2 FDA Photosafety Testing Guidance 397 20.3
Status of In Vivo Testing for Photocarcinogenesis 417 20.4
Photocarcinogenesis Study Designs 418 20.5 Photo Co-Carcinogenesis 418 20.6
Future Testing Concepts, with Emphasis on Biomarkers 423 21 Degradants,
Impurities, Excipients and Metabolites 431 Robert E. Osterberg and Mark W.
Powley 21.1 Degradants, Impurities, and Excipients 431 21.2 Metabolites 442
References 446 Index 449