Drug studies in the elderly: methodological concerns
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Plenum Medical Book
1986
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXV, 438 S. Ill., graph. Darst. |
| ISBN: | 0306423111 |
Internformat
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| 650 | 4 | |a Old persons - Drug therapy | |
| 650 | 4 | |a Médicaments - Essais cliniques | |
| 650 | 4 | |a Médicaments - Métabolisme - Âge, Facteurs de l' | |
| 650 | 4 | |a Pharmacologie gériatrique - Recherche - Méthodologie | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Aging | |
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| 650 | 4 | |a Drugs |x Metabolism |x Age factors | |
| 650 | 4 | |a Drugs |x Testing | |
| 650 | 4 | |a Geriatric pharmacology |x Research |x Methodology | |
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Datensatz im Suchindex
| _version_ | 1804115619405103104 |
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| adam_text | - 2*4 DRUG STUDIES IN THE ELDERLY METHODOLOGICAL CONCERNS EDITED BY NEAL
R. CUTLER, M.D. DIRECTOR, DEPARTMENT OF GERIATRICS CEDARS-SINAI MEDICAL
CENTER UNIVERSITY OF CALIFORNIA-LOS ANGELES SCHOOL OF MEDICINE LOS
ANGELES, CALIFORNIA AND PREM K. NARANG, PH.D. SUPERVISOR, CLINICAL
PHARMACOKINETICS RESEARCH LABORATORY PHARMACY DEPARTMENT CLINICAL CENTER
NATIONAL INSTITUTES OF HEALTH BETHESDA, MARYLAND PLENUM MEDICAL 6OOK
COMPANY NEW YORK AND LONDON CONTENTS PART I RESEARCH DETERMINANTS IN
AGING CHAPTER 1 EPIDEMIOLOGY AND DEMOGRAPHY OF AGING: SOME LESSONS IN
SHORTSIGHTEDNESS THOMAS M. VOGT 1. INTRODUCTION 3 2. DEMOGRAPHIC TRENDS
IN AGING 4 2.1. MIGRATION OF THE ELDERLY 6 2.2. PATTERNS OF LIFE CHANGES
8 2.3. LIFE EXPECTANCY 8 3. EPIDEMIOLOGY OF HEALTH AND ILLNESS AMONG THE
ELDERLY 10 3.1. PREVALENCE OF VARIOUS MEDICAL CONDITIONS IN THE ELDERLY
10 3.2. CARDIOVASCULAR DISEASE AMONG THE ELDERLY 13 3.3. AGING AND
DEMENTIA 15 3.4. INJURIES AND THE ELDERLY 17 3.5. WEIL-BEING AND THE
ELDERLY 18 3.6. SUICIDE 19 3.7. DISABILITY 19 4. DRUGS AND THE ELDERLY
20 5. OVERVIEW 22 REFERENCES 23 XVI CONTENTS CHAPTER 2 AGE: A COMPLEX
VARIABLE PREM K. NARANG 1. INTRODUCTION 29 2. DEFINING THE AGE VARIABLE:
DOES IT DESCRIBE AGING? 31 2.1. BIOLOGICAL AGE 31 2.2. FUNCTIONAL AGE 37
2.3. PITFALLS OF AGE CONCEPTS 40 3. CLINICAL TRIALS IN GERIATRICS:
PHARMACOLOGICAL BASIS 42 4. CONCLUSIONS 46 REFERENCES 47 CHAPTER 3
PHYSIOLOGICAL CHANGES WITH AGING: RELEVANCE TO DRUG STUDY DESIGN
ALEXANDER M. M. SHEPHERD 1. INTRODUCTION 49 2. DRUG ABSORPTION 51 2.1.
REDUCED GASTRIC MOTILITY 51 2.2. INCREASED GASTRIC PH 52 2.3. REDUCED
SMALL INTESTINAL ABSORPTIVE SURFACE AREA 52 2.4. REDUCED PORTAL
CIRCULATION 52 3. DRUG DISTRIBUTION 53 3.1. PLASMA PROTEIN LEVELS 53
3.2. PLASMA VOLUME 54 3.3. LEAN-TO-FAT RATIO 54 3.4. RED-BLOOD-CELL
CHANGES 55 3.5. DISTRIBUTION INTO URINE 55 4. DRUG METABOLISM 55 4.1.
LIVER BLOOD FLOW 57 4.2. LIVER SIZE 57 4.3. NUMBER AND FUNCTION OF
INDIVIDUAL HEPATOCYTES 57 4.4. HEPATIC METABOLIZING CAPACITY 58 4.5.
ENZYME INDUCTION 58 5. RENAL DRUG EXCRETION 59 6. DRUG RESPONSE 60 7.
CONCLUSION 62 REFERENCES 62 CONTENTS XVII CHAPTER 4 IMMUNITY AND AGING
WILLIAM B. ERSHIER AND MARC E. WEKSLER 1. INTRODUCTION 69 2. THYMUS
GLAND AND AGING 70 3. IMMUNOSENESCENCE AT THE CELLULAR LEVEL 71 4.
METHODOLOGICAL CONCERNS FOR BASIC IMMUNOLOGICAL RESEARCH IN AGING 73 5.
CLINICAL CONSEQUENCES 73 6. METHODOLOGICAL CONCERNS FOR CLINICAL
RESEARCH IN IMMUNOLOGY AND AGING 75 REFERENCES 76 CHAPTER 5
CARDIOVASCULAR CHANGES WITH AGING BRIAN F. JOHNSON AND JANICE C.
HITZHUSEN 1. INTRODUCTION 81 2. PATHOLOGICAL CHANGES 81 3. PHYSIOLOGICAL
AND BIOCHEMICAL CHANGES 83 4. ABNORMALITIES OF BLOOD PRESSURE 84 5.
MAXIMAL WORK PERFORMANCE 86 6. INVASIVE PROCEDURES 86 7.
ECHOCARDIOGRAPHY 88 8. RADIONUCLIDE TECHNIQUES*THALLIUM 201 90 9.
RADIONUCLIDE TECHNIQUES*EQUILIBRIUM ANGIOGRAPHY 90 10.
ELECTROCARDIOGRAPHIC CHANGES 94 11. CONCLUSIONS 95 REFERENCES 95 CHAPTER
6 THE EFFECTS OF AGE ON HEPATIC DRUG METABOLISM CHO-MING LOI AND ROBERT
E. VESTAL 1. INTRODUCTION 101 1.1. HEPATIC ANATOMICAL CHANGES WITH AGE
101 1.2. HEPATIC PHYSIOLOGICAL CHANGES WITH AGE 102 CONTENTS 2.
PHYSIOLOGICAL MODEL OF HEPATIC DRUG METABOLISM 102 2.1. CLEARANCE
CONCEPT 103 2.2. INTRINSIC CLEARANCE 103 2.3. DRUG BINDING 104 2.4.
CLASSIFICATION OF DRUGS ACCORDING TO EXTRACTION RATIO 104 2.5. SYSTEMIC
TOTAL DRUG CLEARANCE AND APPARENT ORAL DRUG CLEARANCE 105 2.6.
FIRST-PASS METABOLISM 106 2.7. ESTIMATION OF HEPATIC BLOOD FLOW AND
INTRINSIC CLEARANCE 107 3. PHYSIOLOGICAL CHANGES IN THE LIVER WITH AGE
108 3.1. LIVER BLOOD FLOW 108 3.2. DRUG-METABOLIZING ENZYME ACTIVITY 109
3.3. DRUG BINDING 113 4. METHODOLOGICAL CONSIDERATIONS 114 4.1. SUBJECT
SELECTION 115 4.2. STUDY DESIGN 116 4.3. PROTOCOL SELECTION 116 4.4.
DATA ANALYSIS 117 5. CONCLUSIONS 118 REFERENCES 118 CHAPTER 7
HEMATOLOGICAL EFFECTS OF AGING: CONSIDERATIONS FOR CLINICAL TRIALS
ELIZABETH J. READ AND HARVEY G. KLEIN 1. INTRODUCTION 123 2. EFFECTS OF
AGING ON BLOOD CELLS AND BONE MARROW 124 2.1. RED BLOOD CELLS 124 2.2.
LEUKOCYTES 131 2.3. PLATELETS 134 2.4. BONE MARROW: CELLULARITY,
CYTOGENETICS, ANDFUNCTION 136 3. EFFECTS OF DRUGS ON THE BLOOD AND BONE
MARROW 140 3.1. GENERAL CONSIDERATIONS 140 3.2. ARE THE ELDERLY MORE
SUSCEPTIBLE TO DRUG EFFECTS ON THE BLOOD AND BONE MARROW? 141 4.
METHODOLOGICAL CONSIDERATIONS FOR CLINICAL DRUG TRIALS IN THE ELDERLY
143 REFERENCES 144 CONTENTS XIX CHAPTER 8 THE AGING BRAIN NEAL R. CUTLER
1. INTRODUCTION 151 2. BRAIN METABOLISM AND AGING IN THE RAT 152 3. THE
STRESSED NERVOUS SYSTEM 154 4. CEREBRAL METABOLIC FUNCTION AND AGING IN
HUMANS 155 5. CEREBRAL METABOLIC FUNCTION AND ALZHEIMER S DISEASE 158 6.
RECEPTOR FUNCTION AND THE AGING BRAIN 160 7. SUMMARY 161 REFERENCES 162
PART II PHARMACOKINETICS AND PHARMACODYNAMICS IN THE ELDERLY CHAPTER 9
THE TRICYCLIC ANTIDEPRESSANTS MATTHEW V. RUDORFER AND WILLIAM Z. POTTER
1. INTRODUCTION 167 2. DIAGNOSIS 168 3. PHARMACOKINETIC FACTORS 169 3.1.
DRUG INTERACTIONS 176 3.2. COEXISTING ORGANIC PATHOLOGY 176 4.
PHARMACODYNAMIC FACTORS 178 4.1. INTRINSIC DRUG ACTIONS 178 4.2.
COEXISTING ORGANIC PATHOLOGY .. 180 4.3. ADDITIVE DRUG EFFECTS 182
REFERENCES 183 CHAPTER 10 METHODOLOGICAL CONCERNS FOR CLINICAL TRIALS IN
GERIATRICS: BENZODIAZEPINES DARRELL R. ABERNETHY 1. INTRODUCTION 189 2.
PHARMACOKINETIC TRIALS 190 XX CONTENTS 2.1. SELECTION OF SUBJECT
POPULATIONS 190 2.2. DESIGN OF THE PHARMACOKINETIC STUDY 191 3.
BENZODIAZEPINE PHARMACODYNAMIC STUDIES IN GERIATRICS ... 196 3.1.
DRUG-SENSITIVE PHARMACODYNAMIC MEASURES 197 3.2. REVIEW OF
BENZODIAZEPINE PHARMACODYNAMICS IN THE ELDERLY 197 3.3. PHARMACODYNAMICS
IN ELDERLY PATIENTS WITH UNDERLYING DISEASE 200 4. CONCLUSION 201
REFERENCES 202 CHAPTER 11 EFFECT OF AGE ON THE CLINICAL PHARMACOKINETICS
OF ANTIARRHYTHMIC DRUGS J. W. MASSARELLA AND K.-C. KHOO 1. INTRODUCTION
207 2. MAJOR ANTIARRHYTHMIC AGENTS 208 2.1. DISOPYRAMIDE 208 2.2.
LIDOCAINE 210 2.3. PROCAINAMIDE 213 2.4. QUINIDINE 215 3. NEW
ANTIARRHYTHMIC AGENTS 219 3.1. AMIODARONE 219 3.2. CIBENZOLINE 222 3.3.
ENCAINIDE 222 3.4. FLECAINIDE 226 3.5. LORCAINIDE 228 3.6. MEXILETINE ,
231 3.7. PIRMENOL 233 3.8. PROPAFENONE 235 3.9. TOCAINIDE 235 4.
COMMENTARY 239 REFERENCES 241 CHAPTER 12 BETA BLOCKERS IN THE ELDERLY
DAVID S. ROFFMAN AND ALAN FORREST 1. INTRODUCTION 249 2.
PHARMACOKINETICS OF BETA BLOCKERS IN THE ELDERLY 250 CONTENTS XXI 3.
SYSTEMIC BIOAVAILABILITY 250 4. DISTRIBUTION 253 5. CLEARANCE 254 6.
SENSITIVITY OF BETA BLOCKERS 262 7. BETA-BLOCKER EFFICACY 264 8.
BETA-BLOCKER TOXICITY 266 9. SUGGESTIONS REGARDING PHARMACOKINETIC STUDY
DESIGN .... 267 10. CONCERNS FOR FUTURE INVESTIGATIONS 270 REFERENCES
271 CHAPTER 13 ANTIEPILEPTIC DRUGS IN THE ELDERLY WILLIAM H. THEODORE 1.
INTRODUCTION 273 2. STUDIES OF ANTIEPILEPTIC DRUG EFFICACY AND TOXICITY
274 3. AED PHARMACOLOGY IN THE ELDERLY 276 REFERENCES 279 CHAPTER 14
PHARMACOKINETICS AND BIOAVAILABILITY OF CORTICOSTEROIDS IN THE TREATMENT
OF NEUROLOGICAL DISEASES OF THE ELDERLY MARINOS C. DALAKAS 1.
INTRODUCTION 283 2. FACTORS THAT INFLUENCE CLINICAL RESPONSES TO
ADMINISTERED STEROIDS :*.. 284 2.1. NORMAL BIOAVAILABILITY AND
PHARMACOKINETICS 284 2.2. PHARMACOKINETIC CONSIDERATIONS OF STEROIDS
ADMINISTERED IN GERIATRIC PATIENTS 286 3. ADMINISTRATION OF
CORTICOSTEROIDS IN NEUROMUSCULAR DISEASES OF THE ELDERLY 288 3.1. THE
AGING NEUROMUSCULAR SYSTEM 288 3.2. COMMON NEUROMUSCULAR PROBLEMS IN THE
AGED THAT NEED STEROID THERAPY 290 3.3. INCIDENCE OF SIDE EFFECTS FROM
THERAPEUTIC DOSES OF CORTICOSTEROIDS IN THE ELDERLY 293 4. CONCLUSIONS
295 REFERENCES 295 XXII CONTENTS CHAPTER 15 PHARMACOLOGICAL TREATMENT OF
PARKINSON S DISEASE DONALD B. CALNE AND ARTO LAIHINEN 1. INTRODUCTION
299 2. LEVODOPA 301 3. EXTRACEREBRAL DECARBOXYLASE INHIBITORS 303 4.
ARTIFICIAL DOPAMINE AGONISTS 303 5. MONOAMINE OXIDASE INHIBITORS 306 6.
ANTICHOLINERGICS 308 7. AMANTADINE 309 8. CONCLUSIONS 309 REFERENCES 310
CHAPTER 16 COGNITIVE ENHANCERS IN ALZHEIMER S DISEASE NEAL R. CUTLER AND
PREM K. NARANG 1. INTRODUCTION 313 2. EMPIRICAL THERAPY 315 3.
PHARMACOLOGICAL BASIS FOR NEUROCHEMICAL INVESTIGATIONS 317 3.1.
CHOLINERGIC SYSTEM 318 3.2. NORADRENERGIC SYSTEM 320 3.3.
DOPAMINERGIC/GABAERGIC SYSTEMS 320 3.4. SEROTONINERGIC SYSTEM 321 3.5.
NEUROPEPTIDERGIC SYSTEMS 324 3.6. GLYCOLYTIC ENZYMES 325 4. BRAIN
TRANSPLANTATION 326 5. METHODOLOGICAL CONCERNS 326 5.1. SUBJECT
DESCRIPTION 326 5.2. DESCRIPTION OF SEVERITY 327 5.3. SCREENING 327 5.4.
DURATION OF A THERAPEUTIC TRIAL 328 5.5. ROLE OF PILOT STUDIES 328 5.6.
NEUROPSYCHOLOGICAL MEASURES 328 5.7. END-ORGAN MEASURES 329 6.
CONCLUSION 329 REFERENCES 330 CONTENTS XXIII PART III GENERAL
PERSPECTIVES CHAPTER 17 DOSAGE FORM CONSIDERATIONS IN CLINICAL TRIALS
INVOLVING ELDERLY PATIENTS R. GARY HOLLENBECK AND PETER P. LAMY 1.
INTRODUCTION 335 2. DOSAGE CONTROL AND FLEXIBILITY 338 3. COMPLIANCE 344
4. DOSAGE FORM PERFORMANCE IN ELDERLY PATIENTS 346 5. CONCLUSIONS 351
REFERENCES 352 CHAPTER 18 CLINICAL TRIAL DESIGN*INDUSTRY PERSPECTIVE
WILLIAM B. ABRAMS AND BRUCE E. RODDA 1. INTRODUCTION 355 2.
INDUSTRY-SPONSORED DRUG STUDIES 357 3. ELDERLY ISSUES 358 4. PHASE I:
PHARMACOKINETICS 359 5. PHASE II 361 6. SUBJECT SELECTION 362 7. PHASE
III 363 8. NEW THERAPEUTIC OBJECTIVES 366 9. CONCLUSIONS -. 366
REFERENCES 367 CHAPTER 19 METHODOLOGICAL ISSUES: A REGULATORY
PERSPECTIVE PAUL LEBER 1. INTRODUCTION 369 2. DOMESTIC DRUG REGULATION:
ITS AIMS AND REQUIREMENTS 369 3. DRUG DEVELOPMENT PROGRAM DESIGN 371
IXIV CONTENTS 4. SAFETY, EFFICACY, AND DIRECTIONS FOR USE 373 4.1.
EFFICACY ISSUES ; 374 4.2. OUTCOME ASSESSMENT MEASURES 375 4.3. SAFETY
376 5. SPECIAL STUDIES 377 6. CONCLUSION 378 REFERENCES 379 CHAPTER 20
STATISTICAL ANALYSIS OF DRUG DISPOSITION DATA DAVID G. COVELL AND PREM
K. NARANG 1. INTRODUCTION 381 2. DETERMINISTIC APPROACH 384 2.1. MODEL
DEVELOPMENT 384 2.2. DATA ANALYSIS 386 2.3. PARAMETER ESTIMATION 386
2.4. WEIGHTING OF DATA 388 2.5. MODEL VALIDITY 390 2.6. MODEL
DISCRIMINATION AND SELECTION 393 2.7. VARIANCE ESTIMATES FOR MODEL
PARAMETERS 395 2.8. CORRELATION OF MODEL PARAMETERS 397 3.
NONDETERMINISTIC APPROACH 397 3.1. MARKOVIAN APPROACH 398 3.2.
POPULATION STATISTICS 399 3.3. KALMAN FILTERING 401 REFERENCES 404
CHAPTER 21 ANALYTICAL METHODS LAWRENCE J. LESKO 1. INTRODUCTION 407 2.
INSTRUMENTATION 408 3. METHOD DEVELOPMENT 409 4. QUALITY CONTROL 410 5.
SPECIMEN COLLECTION AND STORAGE 411 6. METABOLITE MEASUREMENT 413 7.
PLASMA PROTEIN BINDING 415 REFERENCES 416 CONTENTS XXV CHAPTER 22
NURSING PERSPECTIVES ON CLINICAL TRIALS IN GERIATRICS BARBARA R. HELLER,
MAUREEN E. POWER, AND GEORGEANNE COX SANTOLLA 1. INTRODUCTION 417 2.
PLANNING THE PROTOCOL 418 3. IN-SERVICE EDUCATION 419 4. SUBJECT
SCREENING 421 5. INFORMED CONSENT 421 6. PRESERVATION OF PATIENT COMFORT
AND SAFETY 422 7. ADMINISTRATION OF THE INVESTIGATIONAL AGENT 422 8.
SCHEDULING AND COLLECTION OF DATA 424 9. DOCUMENTATION 424 10.
CONTROLLING VARIABLES 424 11. COMPLIANCE 425 12. DISCHARGE PLANNING AND
FOLLOW-UP 426 13. PATIENT TEACHING AND COUNSELING 426 14. CLINICAL NURSE
SPECIALIST 427 15. THE NURSING ADMINISTRATOR 427 16. CONCLUSION 428
REFERENCES 428 INDEX 429
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| indexdate | 2024-07-09T15:25:30Z |
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| isbn | 0306423111 |
| language | English |
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| physical | XXV, 438 S. Ill., graph. Darst. |
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| spelling | Drug studies in the elderly methodological concerns ed. by Neal R. Cutler ... New York [u.a.] Plenum Medical Book 1986 XXV, 438 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Old persons - Drug therapy Médicaments - Essais cliniques Médicaments - Métabolisme - Âge, Facteurs de l' Pharmacologie gériatrique - Recherche - Méthodologie Aged Aging Clinical Trials as Topic Drugs Metabolism Age factors Drugs Testing Geriatric pharmacology Research Methodology Pharmacology, Clinical Cutler, Neal R. Sonstige oth GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=000737680&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Drug studies in the elderly methodological concerns Old persons - Drug therapy Médicaments - Essais cliniques Médicaments - Métabolisme - Âge, Facteurs de l' Pharmacologie gériatrique - Recherche - Méthodologie Aged Aging Clinical Trials as Topic Drugs Metabolism Age factors Drugs Testing Geriatric pharmacology Research Methodology Pharmacology, Clinical |
| title | Drug studies in the elderly methodological concerns |
| title_auth | Drug studies in the elderly methodological concerns |
| title_exact_search | Drug studies in the elderly methodological concerns |
| title_full | Drug studies in the elderly methodological concerns ed. by Neal R. Cutler ... |
| title_fullStr | Drug studies in the elderly methodological concerns ed. by Neal R. Cutler ... |
| title_full_unstemmed | Drug studies in the elderly methodological concerns ed. by Neal R. Cutler ... |
| title_short | Drug studies in the elderly |
| title_sort | drug studies in the elderly methodological concerns |
| title_sub | methodological concerns |
| topic | Old persons - Drug therapy Médicaments - Essais cliniques Médicaments - Métabolisme - Âge, Facteurs de l' Pharmacologie gériatrique - Recherche - Méthodologie Aged Aging Clinical Trials as Topic Drugs Metabolism Age factors Drugs Testing Geriatric pharmacology Research Methodology Pharmacology, Clinical |
| topic_facet | Old persons - Drug therapy Médicaments - Essais cliniques Médicaments - Métabolisme - Âge, Facteurs de l' Pharmacologie gériatrique - Recherche - Méthodologie Aged Aging Clinical Trials as Topic Drugs Metabolism Age factors Drugs Testing Geriatric pharmacology Research Methodology Pharmacology, Clinical |
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