Table Of Content

AUTHOR INDEX TO VOLUME 5 Andrews EB, 331 MacLeod SJ, 201, 203 Magistrelli GC, 77 Bernstein DF, 1 McAllister RG, 61 Bortnichak EA, 255 McFarland BH, 331 Boyer JG, 49 Michels KB, 11 Brickley M, 255 Mildvan D, 295 Mullooly JP, 331 Champey Y, 213 Narang PK, 241 Cocchetto DM, 49 Cutler NR, 241 Ott T, 285 Davies RO, 221 Patterson JS, 207 Deatherage B, 291 Pilati C, 49 DiMasi JA, 19 Pippenger CE, 313 Drake M, 319 Roy DJ, 89 Edlavitch SA, 125 Schultz NJ, 255 Simon JM, 347 Faich GA, 11 Sramek JJ, 241 Stanfield JA, 347 Gause D, 255 Swedburg K, 265 Gibson PA, 323 Swinehart JM, 35 Goyer R, 85 Sykes RS, 55 Tiano FJ, 1 Hayes AH, 111 Tilson HH, 331 Hayes AH, 227 Hvidberg EF, 105 Valanis BG, 331 Johnson RE, 331 Walker AM,, 255 Wannamaker BB, 307 Lanza LL, 255 Wiklund I, 265 Lasagna L, 19 Levine RJ, 99 Younger M, 275 Journal of Clinical Research and Pharmacoepidemiology 5, 361 (1991) © 1991 Associates of Clinical Pharmacology 361 Published by Elsevier Science Publishing Co., Inc. 0889-58 13/91/$3.50 655 Avenue of the Americas, New York, NY 10010 Se ene aes , . . . x “ ae RP cae SUBJECT INDEX TO VOLUME 5 ABSTRACTS Entering Two Double-Blind Multicen- Abstracts: 7th International Conference ter Clinical Trials, 49, 55, 61 on Pharmacoepidemiology: August 26- The Patient as the Ethical Reconciliating 29, 1991, Basel Switzerland, 131 Cornerstone Between Investigators, Regulators, and the Pharmaceutical ACP Spring 1991 Poster Abstracts, 63 Industry: An Introduction to the Round Table Discussion, 111 ACYCLOVIR Patient Recruitment and Enrollment into Method of Examining Oral Acyclovir Clinical Trials: A Discussion of Spe- Use for Adverse Events, 331 cific Methods and Disease States, 35 The Role of the Staff Nurse in Clinical AIDS Drug Trials: A Descriptive Study, 347 AIDS: Therapeutic and Educational Toward a Universal Standard Code of Approaches: Proceedings of a Scien- Ethics?: A Round Table Discussion, tific Session at the Annual Meeting of 115 the Associates of Clinical Pharmacol- The U.K. Versus the U.S. Perspective, ogy, Montreal, Quebec, May 1990, 295 207 The U.S. Perspective, 99 ALZHEIMER’S DISEASE A Universal Clinical Procedure: A Uto- Geriatrics: Clinical Trials in an Aging pia?: A Round Table Discussion, 231 Population, 241 CONGESTIVE HEART FAILURE CLINICAL SUPPLIES Some Methodological Problems in Ana- Preparation, Packaging, and Labeling of lyzing Quality of Life Data in Severe Investigational Drug Supplies. Part I: Congestive Heart Failure Patients, 265 Preparation of Investigational Drug Supplies, 1 DATABASES Linked Databases (LDs) and Epidemiol- CLINICAL TRIALS ogy, 11 Basic Ethical Considerations in Clinical Trials and Their Rationale, 89 DRUG SUPPLIES The Canadian Versus the U.S. Perspec- Preparation, Packaging, and Labeling of tive, 221 Investigational Drug Supplies. Part I: The Clinical Trial in Canada, the U.S., Preparation of Investigational Drug and Nordic and EEC Countries, 81, Supplies, 1 199 The Clinical Trial in Canada, the U.S., ELECTROCARDIOGRAPHIC (EKG) and Nordic and EEC Countries. Part TRACING II.: Undertaking the Clinical Trial, 203 Misrepresentation of a Patient’s Heart The Clinical Trial in Canada, the U.S., Rate and EKG Configuration by a and Nordic and EEC Countries. Part Computer Assisted Monitoring Sys- I: Ethical Aspects in Clinical Studies, tem, 275 85 The EEC and Nordic Countries’ Per- EPILEPSY spectives, Hvidberg EF, 105 Update on Epilepsy: Advances and Fu- The European Perspective, 213 ture Directions, 319 Geriatrics: Clinical Trials in an Aging Update on Epilepsy: Approaches to Population, 241 Prediction of Idiosyncratic Reactions Laboratory Charges Associated with to Anti-Epileptic Drugs, 313 Achieving Serum Theophylline Con- Update on Epilepsy: Diagnosis, 307 centrations of 10-20 ug/ml in Patients Update on Epilepsy: Proceedings of a Journal of Clinical Research and Pharmacoepidemiology 5, 363-365 (1991) © 1991 Associates of Clinical Pharmacology Published by Elsevier Science Publishing Co., Inc. 363 655 Avenue of the Americas, New York, NY 10010 0889-58 13/91/$3.50 Subject Index J. Clin. Res. Pharmacoepidemiol. 5:363-—365 (1991) Scientific Session at the Annual Meet- METABOLISM ing of the Associates of Clinical Phar- Geriatrics: Clinical Trials in an Aging macology, Montreal, Quebec, May, Population, 241 1990, 305 Update on Epilepsy: Psychosocial Is- METHODOLOGY sues, 323 Some Methodoligical Problems in Ana- lyzing Quality of Life Data in Severe Congestive Heart Failure Patients, 265 ETHICS Basic Ethical Considerations in Clinical NONSTEROIDAL ANTI-INFLAMMA- Trials and Their Rationale, 89 TORY DRUGS (NSAIDs) The EEC and Nordic Countries’ Per- The Influence of Prior Prescription of H, spectives, 105 Blockers on the Use of NSAIDs, 255 The European Perspective, 213 The Patient as the Ethical Reconciliating PATENTS Cornerstone Between Investigators, Development of Supplemental Indica- Regulators, and the Pharmaceutical tions for Already-Approved Drugs by Industry: An Introduction to the the United States Pharmaceutical Round Table Discussion, 111 Industry, 19 Pharmacoepidemiology Continues Healthy Growth, 125 PATIENT RECRUITMENT AND EN- Toward a Universal Standard Code of ROLLMENT Ethics?: A Round Table Discussion, Patient Recruitment and Enrollment into 115 Clinical Trials: A Discussion of Spe- The U.S. Perspective, 99 cific Methods and Disease States, 35 FDA PHARMACODYNAMICS Must the FDA Guidelines Be the Golden Geriatrics: Clinical Trials in an Aging Rules for a Universally Standardized Population, 241 Patient?: An Introduction to the Round Table Discussion, 227 PHARMACOEPIDEMIOLOGY Linked Databases (LDs) and Epidemiol- GENERIC COMPETITION ogy, 11 Development of Supplemental Indica- Pharmacoepidemiology Continues a tions for Already-Approved Drugs by Healthy Growth, 125 the United States Pharmaceutical Industry, 19 POSTMARKETING SURVEILLANCE Linked Databases (LDs) and Epidemiol- GERIATRICS ogy,1 1 Geriatrics: Clinical Trials in an Aging Population, 241 QUALITY OF LIFE DATA Some Methodological Problems in Ana- H, BLOCKERS lyzing Quality of Life Data in Severe The Influence of Prior Prescription of H, ~ Congestive Heart Failure Patients, 265 Blockers on the Use of NSAIDs, 255 QUINTON 5000 THE INTERNATIONAL SOCIETY Misrepresentation of a Patient’s Heart FOR PHARMACOEPIDEMIOLOGY Rate and EKG Configuration by a (ISPE) Computer Assisted Monitoring Sys- Pharmacoepidemiology Continues tem, 275 Healthy Growth, 125 REGULATORY ASPECTS OF CLINI- LABORATORY CHARGES CAL TRIALS Laboratory Charges Associated with Canadian Versus the U.S. Perspective, Achieving Serum Theophylline Con- 221 centrations of 10-20 ug/ml in Patients The European Perspective, 213 Entering Two Double-Blind Multicen- The U.K. Versus the U.S. Perspective, ter Clinical Trials, 49, 55, 61 207 J. Clin. Res. Pharmacoepidemiol. 5:363-—365 (1991) Subject Index 365 REGULATORY AUDITS SUCCESS RATE An Investigator’s Perspective on Regula- Development of Supplemental Indica- tory Audits of Clinical Investigations, tions for Already-Approved Drugs by 291 the United States Pharmaceutical Regulatory Audits at Study Sites in the Industry, 19 United States, Canada, and Abroad: Proceedings of a Scientific Session at SUPPLEMENTAL INDICATION the Annual Meeting of the Associates Development of Supplemental Indica- of Clinical Pharmacology, Montreal, tions for Already-Approved Drugs by Quebec, May 1990, 283 the United States Pharmaceutical An Sponsor’s Perspective on Regulatory Industry, 19 Audits of Clinical Investigators, 285 SCIENTIFIC SESSIONS PROCEED- THEOPHYLLINE INGS Laboratory Charges Associated with Proceedings from Selected Scientific Achieving Serum Theophylline Con- Sessions at the Annual Meeting of the centrations of 10—20 ug/ml in Patients Associates of Clinical Pharmacology, Entering Two Double-Blind Multicen- Montreal, Quebec, May 1990, 281 ter Clinical Trials, 49, 55, 61