Clinical Measurement in Drug Evaluation / Edition 1

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Overview

Internationally renowned authorities from diverse fields present the principles and practice regarding the measurement of drug effects in humans and its role in the analysis and development of new chemical entities. The main thrust is on surrogate endpoints, peripheral vascular disease, the reliability of data collection and interpretation as well as the identification, predictability and performance of drug interactions and adverse effects.

The book contains black-and-white illustrations.

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Editorial Reviews

From The Critics
Reviewer: John D. Seeger, PharmD, MPH (University of Illinois at Chicago College of Pharmacy)
Description: This book is the published proceedings of a conference covering the topic of clinical measurement. The book takes the form of chapters, with each chapter representing one presentation from the conference.
Purpose: The purpose is to encourage clinicians and scientists to give attention to the precision and reproducibility of the measurement of drug effects. This purpose is both necessary and timely, and the authors largely accomplish the stated objective. A scientist or clinician will find this book stimulating and will be encouraged to think of how it applies to his or her individual research.
Audience: The authors indicate that the target audience is the pharmacologist or pharmaceutical scientist. Although these targets are correct, any clinician or scientist involved in the study or use of drugs will find this book interesting.
Features: The book features a few black-and-white illustrations that help make points, but the most useful illustrative feature is the widespread use of tables to present lists or summaries of information. Most of the chapters are referenced, but a few are not.
Assessment: This book represents a useful compilation of information relating to clinical measurement. The nature of the material (published proceedings of conference) makes some of the reading seem "chatty" and leads to variation from chapter to chapter. The advantage of this format is that the chapters are simultaneously entertaining and informative — a rare combination. Libraries or bookstores that serve individuals involved in pharmaceutical research should consider this book.
John D. Seeger
This book is the published proceedings of a conference covering the topic of clinical measurement. The book takes the form of chapters, with each chapter representing one presentation from the conference. The purpose is to encourage clinicians and scientists to give attention to the precision and reproducibility of the measurement of drug effects. This purpose is both necessary and timely, and the authors largely accomplish the stated objective. A scientist or clinician will find this book stimulating and will be encouraged to think of how it applies to his or her individual research. The authors indicate that the target audience is the pharmacologist or pharmaceutical scientist. Although these targets are correct, any clinician or scientist involved in the study or use of drugs will find this book interesting. The book features a few black-and-white illustrations that help make points, but the most useful illustrative feature is the widespread use of tables to present lists or summaries of information. Most of the chapters are referenced, but a few are not. This book represents a useful compilation of information relating to clinical measurement. The nature of the material (published proceedings of conference) makes some of the reading seem chatty and leads to variation from chapter to chapter. The advantage of this format is that the chapters are simultaneously entertaining and informative—a rare combination. Libraries or bookstores that serve individuals involved in pharmaceutical research should consider this book.
Booknews
Papers from an October 1993 symposium in Edinburgh, Scotland explore clinical measurement in the evaluation of drug effects in humans and its role in the development and evaluation of new chemical entities, touching on facets of the field including surrogate endpoints, peripheral vascular disease, reliability of data, and the identification and interpretation of drug interactions. Annotation c. Book News, Inc., Portland, OR (booknews.com)

3 Stars from Doody
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Product Details

  • ISBN-13: 9780471943914
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 6/16/1995
  • Edition number: 1
  • Pages: 344
  • Product dimensions: 6.24 (w) x 9.31 (h) x 0.98 (d)

Table of Contents

Contributors.

Preface.

SURROGATE ENDPOINTS AS A MEASURE OF DRUG EFFECTS.

A Regulatory Authority's Opinion About Surrogate Endpoints (R. Temple).

What to Measure in Dementia (L. Whalley & S. Gerhand).

Twenty-foour-hour ambulatory arterial (blood) pressure measurement and the assessment of antihypertensive drug efficacy (J. Hasford, W. Meister).

Potential Measurements in Patients with Osteoporosis (C. Miller).

Are bronchial challenge studies indicators of antiasthmatic activity? (A. J. Frew, S. T. Holgate)

DRUGS AFFECTING BLOOD FLOW TO THE PERIPHERAL CIRCULATION.

Measurements of Blood Rheology for the Evaluation of Pharmacological Agents (G. Nash).

Platelet Function Tests (P. Wyld).

Assessment of the Effects of Drugs on the Peripheral Vasculature (D. Webb & M. Hand).

PRECISION, VALIDITY AND REPRODUCIBILITY OF MEASUREMENT.

Bias and Confounding in Clinical Studies (D. Jones).

What Does Good Clinical Practice Have to Say About Clinical Measurement? (E. Hvidberg).

Measurement of bioequivalence and its relevance to tthe clinical situation (T. Salmonson) 

The 'Clinical Trial' of the Clinical Trial (A. Feinstein).

Patient compliancewith prescribed drug regimens: overview of the past 30 yers of research (j. Urguhart).

MEASUREMENT OF ADVERSE EVENTS.

Prediction of drug interactions: implications of recent advances in drug metabolism (G. T. Tucker).

What number of patients is necessary to establish drug safety? (P. R. Jackson, E. J. Wallis, W. w. Yeo, L E. Ramsay)

Accuracy of adverse data from post-marketing studies and the influence on extension of licensed indications (D. H. Lawson).  

Controlled Clinical Trials: Contribution to Drug Safety (M. Langman).

Predicting Adverse Drug Reactions (C. George).

THE EDINBURGH DRUG ABSORPTION FOUNDATION LECTURE.

Interactions in First-Pass Metabolism and Variability in Drug Response (P. Neuvonen).

Index.

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