Preclinical drug development:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Boca Raton [u.a.]
Taylor & Francis
2005
|
| Schriftenreihe: | Drugs and the pharmaceutical sciences
152 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | xiv, 575 p. ill., graph. Darst. |
| ISBN: | 157444882X |
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| 650 | 4 | |a Drug development | |
| 650 | 4 | |a Drug Evaluation, Preclinical |x methods | |
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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
ADMINISTRATION*INFLUENCING 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
ADMINISTRATION*INFLUENCING 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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| index_date | 2024-07-02T13:18:07Z |
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| isbn | 157444882X |
| language | English |
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| spelling | Preclinical drug development [ed. by] Mark C. Rogge ... Boca Raton [u.a.] Taylor & Francis 2005 xiv, 575 p. ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 152 Includes bibliographical references and index Médicaments - Développement Drug development Drug Evaluation, Preclinical methods Drug Industry methods Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Arzneimittelentwicklung (DE-588)4143176-5 s b DE-604 Rogge, Mark C. Sonstige oth Taft, David R. Sonstige oth Drugs and the pharmaceutical sciences 152 (DE-604)BV000002008 152 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014167015&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Preclinical drug development Drugs and the pharmaceutical sciences Médicaments - Développement Drug development Drug Evaluation, Preclinical methods Drug Industry methods Arzneimittelentwicklung (DE-588)4143176-5 gnd |
| subject_GND | (DE-588)4143176-5 (DE-588)4143413-4 |
| title | Preclinical drug development |
| title_auth | Preclinical drug development |
| title_exact_search | Preclinical drug development |
| title_exact_search_txtP | Preclinical drug development |
| title_full | Preclinical drug development [ed. by] Mark C. Rogge ... |
| title_fullStr | Preclinical drug development [ed. by] Mark C. Rogge ... |
| title_full_unstemmed | Preclinical drug development [ed. by] Mark C. Rogge ... |
| title_short | Preclinical drug development |
| title_sort | preclinical drug development |
| topic | Médicaments - Développement Drug development Drug Evaluation, Preclinical methods Drug Industry methods Arzneimittelentwicklung (DE-588)4143176-5 gnd |
| topic_facet | Médicaments - Développement Drug development Drug Evaluation, Preclinical methods Drug Industry methods Arzneimittelentwicklung Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014167015&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT roggemarkc preclinicaldrugdevelopment AT taftdavidr preclinicaldrugdevelopment |