Statistical issues in drug research and development:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York u.a.
Dekker
1990
|
| Series: | Statistics: textbooks and monographs
106 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XI, 366 S. |
| ISBN: | 0824782909 |
Staff View
MARC
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| adam_text | 5 STATISTICAL ISSUES IN DRUG RESEARCH AND DEVELOPMENT EDITED BY KARL E.
PEACE BIOPHARMACEU TICAL RESEARCH CONSULTANTS, INC. ANMARBOR, MICHIGAN
MARCEL DEKKER, INC. NEW YORK AND BASEL CONTENTS PREFACE HI CONTRIBUTORS
IX 1. ASA BIOPHARMACEUTICAL SECTION WORK CROUPS 1 KARL E. PEACE I.
INTRODUCTION 1 II. ASA BIOPHARMACEUTICAL SECTION-WORK GROUP GUIDELINES 5
III. WORK-GROUP TOPICS AND PROBLEMS/ISSUES STATEMENTS 8 IV. WORK-GROUP
PARTICIPANTS 15 V. CONCLUDING REMARKS 17 BIBLIOGRAPHY 18 2.
SUMMARIZATION, ANALYSIS, AND MONITORING OF ADVERSE EXPERIENCES 19
SUZANNE EDWARDS, GARY G. KOCH, WILLIAM A. SOLLECITO, AND KARL E. PEACE
I. INTRODUCTION TO ADVERSE EXPERIENCE DATA IN CLINICAL TRIALS 19 II.
STATISTICAL CONSIDERATIONS 32 III. STATISTICAL METHODOLOGY 43 IV. AN
ANTIHISTAMINE/DECONGESTANT DRUG TRIAL EXAMPLE 65 V. AN ANTIDEPRESSANT
DRUG TRIAL EXAMPLE . 89 VI. AN EXAMPLE USING A SERIES OF ANALGESIC DRUG
TRIALS 109 VII. A CROSSOVER TRIAL EXAMPLE 136 VIII. SUMMARIZATION AND
ANALYSIS SUMMARY 141 IX. PRACTICAL CONSIDERATIONS 146 X. DESIGN,
MONITORING, AND OTHER ANALYSIS ISSUES 150 APPENDIX 160 REFERENCES 161
VI CONTENTS 3. TWO TREATMENT CROSSOVER DESIGNS 171 SYLVAN WALLENSTEIN,
HARJI I. PATEL, GERALD M. FAVA, MARCIA POLANSKY, KARL E. PEACE, SATYA D.
DUBEY, RONALD P. KERSHNER, GEORGE LYNCH, AND MATTHEW KOCH I. II. III.
IV. V. VI. VII. VIII. IX. INTRODUCTION CONSENSUS STATEMENT OVERVIEW
BASELINE MEASUREMENTS IN A 2 X 2 CROSSOVER TRIAL THE TWO-TREATMENT,
TWO-PERIOD, FOUR-SEQUENCE DESIGN CONDITIONAL 2X2 CROSSOVER DESIGNS IN
CLINICAL TRIALS ANALYSIS OF CROSSOVER DESIGNS WHEN THE ERRORS ARE NOT
INDEPENDENT A SURVEY OF CROSSOVER DESIGNS USED IN INDUSTRY CURRENT
THOUGHTS ON CROSSOVER DESIGNS APPENDIX 1 APPENDIX 2 BIBLIOGRAPHY 172 172
173 177 184 191 197 201 209 218 219 220 4. ACTIVE CONTROL EQUIVALENCE
STUDIES 225 ROBERT W. MAKUCH, GORDON PLEDGER, DAVID B. HALL, MARY F.
JOHNSON, JAY HERSON, AND JIANN-PING HSU I. INTRODUCTION 225 II. ACTIVE
CONTROL EQUIVALENCE STUDIES: DO THEY ADDRESS THE EFFICACY ISSUE? 226
III. ACTIVE CONTROL EQUIVALENCE STUDIES: PLANNING AND INTERPRETATION 238
IV. CONSIDERATIONS IN THE INTERPRETATION OF ACTIVE CONTROL EQUIVALENCE
STUDIES , 247 V. THE ASSESSMENT OF STATISTICAL EVIDENCE FROM ACTIVE
CONTROL CLINICAL TRIALS 252 REFERENCES 260 5. OPTIMIZATION IN CLINICAL
TRIALS AND COMBINATION DRUG DEVELOPMENT 263 DONALD M. STABLEIN, JOEL W.
NOVAK, KARL E. PEACE, EUGENE M. LASKA, AND MORRIS ). MEISNER I.
OPTIMIZATION IN CLINICAL TRIALS . 263 II. CONSIDERATIONS IN COMBINATION
DRUG DEVELOPMENT 270 III. HYPOTHESIS TESTING FOR COMBINATION TREATMENTS
276 CONTENTS VII IV. RESPONSE SURFACE METHODOLOGY IN THE DEVELOPMENT OF
ANTIANGINAL DRUGS 285 REFERENCES 301 6. DOSING IN THE ELDERLY 305 ARTHUR
F. JOHNSON, RUKMINI RAJAGOPALAN, AND DAVID S. SALSBURG I. THE ELDERLY IN
CLINICAL TRIALS: WHO AND HOW MANY? 305 II. STEADY-STATE BLOOD LEVELS 312
III. THE DISTRIBUTION OF PATIENT-SPECIFIC ELIMINATION RATES IN
SINGLE-DOSE PHARMACOKINETIC STUDIES 320 REFERENCES 328 7. INTENTION TO
TREAT IN CLINICAL TRIALS 331 LLOYD D. FISHER, DENNIS O. DIXON, JAY
HERSON, RALPH K. FRANKOWSKI, MARTHA S. HEARRON, AND KARL E. PEACE I.
ANALYSIS OF RANDOMIZED CLINICAL TRIALS: INTENTION TO 331 TREAT II.
INTENTION TO TREAT*A SUMMARY VIEW 344 III. INTENTION TO TREAT*ANOTHER
VIEW 346 IV. INTENTION TO TREAT*WHAT IS THE QUESTION? 347 REFERENCES 349
8. DUAL CONTROL CROUPS IN RODENT CARCINOGENICITY STUDIES 351 JOSEPH K.
HASEMAN, GERALD HAJIAN, KENNETH S. CRUMP, MURRAY R. SELWYN, AND KARL E.
PEACE I. INTRODUCTION 351 II. EVALUATING THE ARGUMENTS THAT SUPPORT DUAL
CONTROL GROUPS 352 III. ISSUES RELATED TO THE USE OF DUAL CONTROL GROUPS
355 IV. FACTORS THAT INFLUENCE THE NEED FOR DUAL CONTROL GROUPS 359 V.
CONCLUSION 360 REFERENCES 360 INDEX 363
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| physical | XI, 366 S. |
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| spelling | Statistical issues in drug research and development ed. by Karl E. Peace New York u.a. Dekker 1990 XI, 366 S. txt rdacontent n rdamedia nc rdacarrier Statistics: textbooks and monographs 106 Médicaments - Essais cliniques - Méthodes statistiques Médicaments - Recherche Statistik Clinical Trials as Topic Drug Evaluation Drugs Research Drugs Testing Statistical methods Statistics as Topic Methode (DE-588)4038971-6 gnd rswk-swf Statistik (DE-588)4056995-0 gnd rswk-swf Pharmazie (DE-588)4045705-9 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Pharmazie (DE-588)4045705-9 s Statistik (DE-588)4056995-0 s Methode (DE-588)4038971-6 s DE-604 Peace, Karl E. Sonstige oth Statistics: textbooks and monographs 106 (DE-604)BV000003265 106 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=002612216&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Statistical issues in drug research and development Statistics: textbooks and monographs Médicaments - Essais cliniques - Méthodes statistiques Médicaments - Recherche Statistik Clinical Trials as Topic Drug Evaluation Drugs Research Drugs Testing Statistical methods Statistics as Topic Methode (DE-588)4038971-6 gnd Statistik (DE-588)4056995-0 gnd Pharmazie (DE-588)4045705-9 gnd |
| subject_GND | (DE-588)4038971-6 (DE-588)4056995-0 (DE-588)4045705-9 (DE-588)4143413-4 |
| title | Statistical issues in drug research and development |
| title_auth | Statistical issues in drug research and development |
| title_exact_search | Statistical issues in drug research and development |
| title_full | Statistical issues in drug research and development ed. by Karl E. Peace |
| title_fullStr | Statistical issues in drug research and development ed. by Karl E. Peace |
| title_full_unstemmed | Statistical issues in drug research and development ed. by Karl E. Peace |
| title_short | Statistical issues in drug research and development |
| title_sort | statistical issues in drug research and development |
| topic | Médicaments - Essais cliniques - Méthodes statistiques Médicaments - Recherche Statistik Clinical Trials as Topic Drug Evaluation Drugs Research Drugs Testing Statistical methods Statistics as Topic Methode (DE-588)4038971-6 gnd Statistik (DE-588)4056995-0 gnd Pharmazie (DE-588)4045705-9 gnd |
| topic_facet | Médicaments - Essais cliniques - Méthodes statistiques Médicaments - Recherche Statistik Clinical Trials as Topic Drug Evaluation Drugs Research Drugs Testing Statistical methods Statistics as Topic Methode Pharmazie Aufsatzsammlung |
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