Holdings: Preclinical drug development

Preclinical drug development:

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Bibliographic Details
Format:	Book
Language:	English
Published:	Boca Raton [u.a.] Taylor & Francis 2005
Series:	Drugs and the pharmaceutical sciences 152
Subjects:	Médicaments - Développement Drug development Drug Evaluation, Preclinical > methods Drug Industry > methods Arzneimittelentwicklung Aufsatzsammlung
Online Access:	Inhaltsverzeichnis
Item Description:	Includes bibliographical references and index
Physical Description:	xiv, 575 p. ill., graph. Darst.
ISBN:	157444882X

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MARC


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Record in the Search Index

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adam_text	PRECLINICAL DRUG DEVELOPMENT MARK C. ROGGE ZYMOGENETICS SEATTLE, WASHINGTON, U.S.A. DAVID R. TAFT LONG ISLAND UNIVERSITY BROOKLYN, NEW YORK, U.S.A. TAYLOR & FRANCIS TAYLOR & FRANCIS CROUP BOCA RATON LONDON NEW YORK SINGAPORE CONTENTS FOREWORD LAWRENCE LESKO .... HI PREFACE. . . . V CONTRIBUTORS .... XIII 1. THE SCOPE OF PRECLINICAL DRUG DEVELOPMENT: AN INTRODUCTION AND FRAMEWORK 1 MARK C. ROGGE REFERENCES .... 8 2. INTERSPECIES DIFFERENCES IN PHYSIOLOGY AND PHARMACOLOGY: EXTRAPOLATING PRECLINICAL DATA TO HUMAN POPULATIONS 11 MARILYN N. MARTINEZ 1. OVERVIEW .... 11 2. TOXICOLOGY TESTS: POINTS TO CONSIDER .... 12 3. TOXICOLOGICAL ENDPOINTS .... 13 4. FACTORS THAT CAN INFLUENCE STUDY RESULTS .... 15 5. INTERSPECIES PHARMACOKINETIC DIFFERENCES .... 22 6. ALLOMETRY .... 46 7. CONCLUDING THOUGHTS .... 55 REFERENCES .... 56 3. TRANSGENIC ANIMALS FOR PRECLINICAL DRUG DEVELOPMENT 67 LI-NA WEI 1. INTRODUCTION .... 67 2. PRODUCTION OF TRANSGENIC ANIMALS .... 68 VII VIJJ CONTENTS 3. APPLICATIONS IN PRECLINICAL DRUG DEVELOPMENT .... 83 4. THE PROSPECTIVE .... 89 REFERENCES .... 90 4. PHARMACOKINETICS/ADME OF SMALL MOLECULES 99 VANGALA V. SUBRAHMANYAM AND ALFRED P. TONELLI 1. INTRODUCTION .... 99 2. PHARMACOKINETICS: GENERAL OVERVIEW .... 100 3. MECHANISMS OF SMALL MOLECULE ABSORPTION .... 101 4. MECHANISMS OF SMALL MOLECULE DISTRIBUTION .... 110 5. MECHANISMS OF SMALL MOLECULE METABOLISM .... 113 6. MECHANISMS OF SMALL MOLECULE EXCRETION .... 136 7. SMALL MOLECULE ADME: ISSUES FOR DRUG DEVELOPMENT .... 140 8. PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELING OF PRECLINICAL DATA .... 145 9. CONCLUSIONS .... 147 REFERENCES .... 148 5. PHARMACOKINETICS/ADME OF LARGE MOLECULES 159 RENE BRAECKMAN 1. INTRODUCTION .... 159 2. CLEARANCE MECHANISMS OF PROTEIN THERAPEUTICS .... 160 3. DISTRIBUTION OF PROTEIN THERAPEUTICS .... 171 4. PLASMA PHARMACOKINETICS .... 176 5. PROTEIN BINDING OF PROTEIN THERAPEUTICS .... 180 6. INTERSPECIES SCALING .... 182 7. HETEROGENEITY OF PROTEIN THERAPEUTICS .... 185 8. CHEMICAL MODIFICATIONS OF PROTEIN THERAPEUTICS .... 186 9. IMMUNOGENICITY .... 188 10. CONCLUSIONS AND IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT .... 191 REFERENCES .... 192 6. PRECLINICAL PHARMACOKINETIC-PHARMACODYNAMIC MODELING AND SIMULATION IN DRUG DEVELOPMENT 199 PAOLO VICINI AND PETER L. BONATE 1. INTRODUCTION .... 199 2. WHAT IS A MODEL AND WHY DO WE MAKE THEM? .... 200 CONTENTS IX 3. WHAT CONDITIONS ARE NECESSARY FOR THE PRECLINICAL MODEL TO BE VALID IN HUMANS? .... 200 4. CASE STUDIES .... 202 5. CONCLUSIONS .... 217 REFERENCES .... 219 7. FORMULATION AND ROUTE OF ADMINISTRATIONINFLUENCING DRUG PERMEABILITY AND ABSORPTION 221 MANSOOR A. KHAN AND FAKHRUL AHSAN 1. ORAL DRUG DELIVERY .... 222 2. TRANSDERMAL DRUG DELIVERY .... 229 3. NASAL DRUG DELIVERY .... 233 4. PULMONARY DRUG DELIVERY .... 241 5. CONCLUSIONS AND IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT .... 244 REFERENCES .... 245 8. ASSESSMENT OF PHARMACOKINETICS AND DRUG ACTIVITY: ISOLATED ORGAN SYSTEMS AND THE MEMBRANE TRANSPORTER FAMILY 251 KEVIN R SWEENEY AND DAVID R. TAFT 1. INTRODUCTION .... 251 2. OVERVIEW OF MEMBRANE TRANSPORTERS .... 252 3. EXPERIMENTAL METHODS USED TO STUDY MEMBRANE DRUG TRANSPORT .... 259 4. HEPATOBILIARY TRANSPORT .... 263 5. GASTROINTESTINAL TRANSPORT .... 271 6. RENAL TRANSPORT .... 276 7. CENTRAL NERVOUS SYSTEM TRANSPORT .... 281 8. IMPACT OF MEMBRANE TRANSPORTERS ON OTHER ORGANS AND TISSUES .... 287 9. IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT .... 287 REFERENCES .... 291 9. ALTERNATE METHODS FOR ASSESSING ABSORPTION, METABOLISM, AND ROUTES OF ELIMINATION 303 PETER BULLOCK 1. INTRODUCTION .... 303 2. THE EVOLUTION OF DRUG DISCOVERY AND ITS EFFECT ON PRECLINICAL DEVELOPMENT .... 305 X CONTENTS 3. LEAD SELECTION AND OPTIMIZATION VIA PHARMACEUTICAL PROFILING .... 307 4. CONCLUSION .... 339 REFERENCES .... 339 10. TOXICITY EVALUATIONS: ICH GUIDELINES AND CURRENT PRACTICE 349 JEFFREY L. LARSON 1. CHAPTER OVERVIEW .... 349 2. INTRODUCTION .... 350 3. ICH NON-CLINICAL (PRECLINICAL) TOXICITY GUIDELINES .... 354 4. ADDITIONAL SAFETY TOPICS AND GUIDELINES .... 379 5. NON-CLINICAL DEVELOPMENT PROGRAMS .... 383 6. CONCLUSIONS .... 409 APPENDIX .... 411 REFERENCES .... 411 11. APPLICATION OF PATHOLOGY IN SAFETY ASSESSMENT 415 ROBERT A. ETTLIN AND DAVID E. PRENTICE 1. INTRODUCTION .... 415 2. TECHNICAL POST-MORTEM PROCEDURES .... 430 3. GENERAL PATHOLOGY .... 442 4. TYPICAL NON-NEOPLASTIC ALTERATIONS SEEN IN TOXICITY STUDIES .... 458 5. TYPICAL NEOPLASTIC CHANGES SEEN IN LIFE-TIME BIOASSAYS .... 491 6. INVESTIGATION OF UNCLEAR PATHOLOGICAL FINDINGS .... 498 7. INTERPRETATION OF PATHOLOGICAL FINDINGS .... 499 8. REPORTING .... 505 9. CONCLUSIONS .... 507 REFERENCES .... 508 12. PRINCIPLES OF TOXICOGENOMICS: IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT 531 JIIRGEN BORLAK 1. INTRODUCTION .... 531 2. TRANSCRIPT PROFILING .... 531 3. METHOLOGICAL CONSIDERATIONS .... 532 4. GENE EXPRESSION PROFILING PRACTICAL CONSIDERATIONS .... 541 CONTENTS XI 5. CASE STUDY: ELUCIDATION OF TERATOGENIC MECHANISM(S) OF TOXICITY OF A DEVELOPMENTAL DRUG, EMD 82571 .... 542 6. TURNING DATA INTO KNOWLEDGE .... 548 REFERENCES .... 549 13. UTILIZING THE PRECLINICAL DATABASE TO SUPPORT CLINICAL DRUG DEVELOPMENT 551 HOWARD LEE 1. UTILIZING THE PRECLINICAL DATABASE TO SELECT HUMAN DOSE .... 552 2. UTILIZING THE PRECLINICAL DATABASE TO SUPPORT THE EFFICACY CLAIM FOR REGULATORY APPROVAL .... 557 3. UTILIZING PRECLINICAL DATABASE TO ADDRESS SAFETY CONCERNS .... 559 4. UTILIZING THE PRECLINICAL DATABASE TO DESIGN IN VIVO METABOLIC DRUG-DRUG INTERACTION STUDIES .... 561 5. LIMITATIONS AND PREDICTIVE VALUE OF THE PRECLINICAL DATABASE .... 562 6. CONCLUSIONS .... 563 REFERENCES .... 564 INDEX . ... 571
adam_txt	PRECLINICAL DRUG DEVELOPMENT MARK C. ROGGE ZYMOGENETICS SEATTLE, WASHINGTON, U.S.A. DAVID R. TAFT LONG ISLAND UNIVERSITY BROOKLYN, NEW YORK, U.S.A. TAYLOR & FRANCIS TAYLOR & FRANCIS CROUP BOCA RATON LONDON NEW YORK SINGAPORE CONTENTS FOREWORD LAWRENCE LESKO . HI PREFACE. . . . V CONTRIBUTORS . XIII 1. THE SCOPE OF PRECLINICAL DRUG DEVELOPMENT: AN INTRODUCTION AND FRAMEWORK 1 MARK C. ROGGE REFERENCES . 8 2. INTERSPECIES DIFFERENCES IN PHYSIOLOGY AND PHARMACOLOGY: EXTRAPOLATING PRECLINICAL DATA TO HUMAN POPULATIONS 11 MARILYN N. MARTINEZ 1. OVERVIEW . 11 2. TOXICOLOGY TESTS: POINTS TO CONSIDER . 12 3. TOXICOLOGICAL ENDPOINTS . 13 4. FACTORS THAT CAN INFLUENCE STUDY RESULTS . 15 5. INTERSPECIES PHARMACOKINETIC DIFFERENCES . 22 6. ALLOMETRY . 46 7. CONCLUDING THOUGHTS . 55 REFERENCES . 56 3. TRANSGENIC ANIMALS FOR PRECLINICAL DRUG DEVELOPMENT 67 LI-NA WEI 1. INTRODUCTION . 67 2. PRODUCTION OF TRANSGENIC ANIMALS . 68 VII VIJJ CONTENTS 3. APPLICATIONS IN PRECLINICAL DRUG DEVELOPMENT . 83 4. THE PROSPECTIVE . 89 REFERENCES . 90 4. PHARMACOKINETICS/ADME OF SMALL MOLECULES 99 VANGALA V. SUBRAHMANYAM AND ALFRED P. TONELLI 1. INTRODUCTION . 99 2. PHARMACOKINETICS: GENERAL OVERVIEW . 100 3. MECHANISMS OF SMALL MOLECULE ABSORPTION . 101 4. MECHANISMS OF SMALL MOLECULE DISTRIBUTION . 110 5. MECHANISMS OF SMALL MOLECULE METABOLISM . 113 6. MECHANISMS OF SMALL MOLECULE EXCRETION . 136 7. SMALL MOLECULE ADME: ISSUES FOR DRUG DEVELOPMENT . 140 8. PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELING OF PRECLINICAL DATA . 145 9. CONCLUSIONS . 147 REFERENCES . 148 5. PHARMACOKINETICS/ADME OF LARGE MOLECULES 159 RENE BRAECKMAN 1. INTRODUCTION . 159 2. CLEARANCE MECHANISMS OF PROTEIN THERAPEUTICS . 160 3. DISTRIBUTION OF PROTEIN THERAPEUTICS . 171 4. PLASMA PHARMACOKINETICS . 176 5. PROTEIN BINDING OF PROTEIN THERAPEUTICS . 180 6. INTERSPECIES SCALING . 182 7. HETEROGENEITY OF PROTEIN THERAPEUTICS . 185 8. CHEMICAL MODIFICATIONS OF PROTEIN THERAPEUTICS . 186 9. IMMUNOGENICITY . 188 10. CONCLUSIONS AND IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT . 191 REFERENCES . 192 6. PRECLINICAL PHARMACOKINETIC-PHARMACODYNAMIC MODELING AND SIMULATION IN DRUG DEVELOPMENT 199 PAOLO VICINI AND PETER L. BONATE 1. INTRODUCTION . 199 2. WHAT IS A MODEL AND WHY DO WE MAKE THEM? . 200 CONTENTS IX 3. WHAT CONDITIONS ARE NECESSARY FOR THE PRECLINICAL MODEL TO BE VALID IN HUMANS? . 200 4. CASE STUDIES . 202 5. CONCLUSIONS . 217 REFERENCES . 219 7. FORMULATION AND ROUTE OF ADMINISTRATIONINFLUENCING DRUG PERMEABILITY AND ABSORPTION 221 MANSOOR A. KHAN AND FAKHRUL AHSAN 1. ORAL DRUG DELIVERY . 222 2. TRANSDERMAL DRUG DELIVERY . 229 3. NASAL DRUG DELIVERY . 233 4. PULMONARY DRUG DELIVERY . 241 5. CONCLUSIONS AND IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT . 244 REFERENCES . 245 8. ASSESSMENT OF PHARMACOKINETICS AND DRUG ACTIVITY: ISOLATED ORGAN SYSTEMS AND THE MEMBRANE TRANSPORTER FAMILY 251 KEVIN R SWEENEY AND DAVID R. TAFT 1. INTRODUCTION . 251 2. OVERVIEW OF MEMBRANE TRANSPORTERS . 252 3. EXPERIMENTAL METHODS USED TO STUDY MEMBRANE DRUG TRANSPORT . 259 4. HEPATOBILIARY TRANSPORT . 263 5. GASTROINTESTINAL TRANSPORT . 271 6. RENAL TRANSPORT . 276 7. CENTRAL NERVOUS SYSTEM TRANSPORT . 281 8. IMPACT OF MEMBRANE TRANSPORTERS ON OTHER ORGANS AND TISSUES . 287 9. IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT . 287 REFERENCES . 291 9. ALTERNATE METHODS FOR ASSESSING ABSORPTION, METABOLISM, AND ROUTES OF ELIMINATION 303 PETER BULLOCK 1. INTRODUCTION . 303 2. THE EVOLUTION OF DRUG DISCOVERY AND ITS EFFECT ON PRECLINICAL DEVELOPMENT . 305 X CONTENTS 3. LEAD SELECTION AND OPTIMIZATION VIA PHARMACEUTICAL PROFILING . 307 4. CONCLUSION . 339 REFERENCES . 339 10. TOXICITY EVALUATIONS: ICH GUIDELINES AND CURRENT PRACTICE 349 JEFFREY L. LARSON 1. CHAPTER OVERVIEW . 349 2. INTRODUCTION . 350 3. ICH NON-CLINICAL (PRECLINICAL) TOXICITY GUIDELINES . 354 4. ADDITIONAL SAFETY TOPICS AND GUIDELINES . 379 5. NON-CLINICAL DEVELOPMENT PROGRAMS . 383 6. CONCLUSIONS . 409 APPENDIX . 411 REFERENCES . 411 11. APPLICATION OF PATHOLOGY IN SAFETY ASSESSMENT 415 ROBERT A. ETTLIN AND DAVID E. PRENTICE 1. INTRODUCTION . 415 2. TECHNICAL POST-MORTEM PROCEDURES . 430 3. GENERAL PATHOLOGY . 442 4. TYPICAL NON-NEOPLASTIC ALTERATIONS SEEN IN TOXICITY STUDIES . 458 5. TYPICAL NEOPLASTIC CHANGES SEEN IN LIFE-TIME BIOASSAYS . 491 6. INVESTIGATION OF UNCLEAR PATHOLOGICAL FINDINGS . 498 7. INTERPRETATION OF PATHOLOGICAL FINDINGS . 499 8. REPORTING . 505 9. CONCLUSIONS . 507 REFERENCES . 508 12. PRINCIPLES OF TOXICOGENOMICS: IMPLICATIONS FOR PRECLINICAL DRUG DEVELOPMENT 531 JIIRGEN BORLAK 1. INTRODUCTION . 531 2. TRANSCRIPT PROFILING . 531 3. METHOLOGICAL CONSIDERATIONS . 532 4. GENE EXPRESSION PROFILING PRACTICAL CONSIDERATIONS . 541 CONTENTS XI 5. CASE STUDY: ELUCIDATION OF TERATOGENIC MECHANISM(S) OF TOXICITY OF A DEVELOPMENTAL DRUG, EMD 82571 . 542 6. TURNING DATA INTO KNOWLEDGE . 548 REFERENCES . 549 13. UTILIZING THE PRECLINICAL DATABASE TO SUPPORT CLINICAL DRUG DEVELOPMENT 551 HOWARD LEE 1. UTILIZING THE PRECLINICAL DATABASE TO SELECT HUMAN DOSE . 552 2. UTILIZING THE PRECLINICAL DATABASE TO SUPPORT THE EFFICACY CLAIM FOR REGULATORY APPROVAL . 557 3. UTILIZING PRECLINICAL DATABASE TO ADDRESS SAFETY CONCERNS . 559 4. UTILIZING THE PRECLINICAL DATABASE TO DESIGN IN VIVO METABOLIC DRUG-DRUG INTERACTION STUDIES . 561 5. LIMITATIONS AND PREDICTIVE VALUE OF THE PRECLINICAL DATABASE . 562 6. CONCLUSIONS . 563 REFERENCES . 564 INDEX . . 571
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title	Preclinical drug development
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