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Preface | p. vii |
Acknowledgments | p. xi |
Contributors | p. xv |
Introduction and Specific Requirements | |
The Common Technical Document-A Global Format for Registration Files | p. 1 |
The Electronic Common Technical Document | p. 14 |
CTD Module 1-Administrative Information | p. 26 |
Environmental Risk Assessment | p. 47 |
Common Technical Document Summaries | |
Quality Overall Summary | p. 78 |
The Nonclinical Overview and Summary | p. 89 |
The Clinical Overview and Summary | p. 107 |
Quality-Drug Substance and Drug Product | |
Drug Substance-General Information | p. 119 |
Drug Substance-Manufacture | p. 124 |
Drug Substance-Characterization | p. 136 |
Control of Drug Substance | p. 154 |
Drug Substance and Drug Product-Container/Closure | p. 169 |
Drug Product-Description and Composition | p. 179 |
Drug Product-Pharmaceutical Development | p. 184 |
Drug Product-Manufacture and Process Validation | p. 210 |
Drug Product-Excipients | p. 234 |
Control Tests on the Finished Product | p. 248 |
Reference Standards or Materials | p. 264 |
Drug Substance and Drug Product Stability | p. 269 |
Transmissible Spongiform Encephalopathy Agent and Adventitious Agent Requirements for Non-Biological Pharmaceutical Products | p. 290 |
Nonclinical Studies | |
Nonclinical Testing Strategy | p. 300 |
Pharmacology | p. 323 |
Nonclinical Pharmacokinetics and Toxicokinetics | p. 336 |
Single and Repeat Dose Toxicity | p. 377 |
Genotoxicity | p. 402 |
Carcinogenicity | p. 419 |
Reproductive and Developmental Toxicity | p. 429 |
Safety Pharmacology Testing: Past, Present, and Future | p. 441 |
Immunotoxicology | p. 467 |
Local Tolerance and Other Toxicity Studies | p. 478 |
Clinical Studies | |
Bioavailability and Bioequivalence Studies | p. 490 |
Pharmacokinetics in Man | p. 520 |
Pharmacodynamics | p. 537 |
Statistical Concepts in the Design and Analysis of Clinical Trials | p. 554 |
Efficacy and Safety Clinical Studies | p. 574 |
Postmarketing Evaluation | p. 589 |
Pharmacovigilance and Risk Management | p. 603 |
Pregnancy and Children | p. 622 |
Ageing Populations and Development of Medicinal Products | p. 633 |
Good Clinical Practice | p. 658 |
Prevention and Detection of Fraud in Clinical Trials | p. 685 |
Special Products and Modeling | |
Aspects of Biological and Biotechnological Medicinal Products | p. 697 |
Device-Drug Combination Products | p. 717 |
Recommendations for Toxicological Evaluation of Nanoparticle Medicinal Products Jean-Roger Claude and Members of Afssaps Working Party | p. 755 |
Modeling and Medical Product R&D | p. 762 |
List of Acronyms and Abbreviations | p. 774 |
List of Key Technical and Regulatory Information Sources | p. 784 |
Index | p. 787 |
Table of Contents provided by Ingram. All Rights Reserved. |
The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.