Clinical Measurement in Drug Evaluation

ISBN-13: 9780471943914 / Angielski / Twarda / 1995 / 344 str.

Nimmo; David Tucker; Walter S. Nimmo

Opis

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.

Spis treści

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.

Blurb

Measurement of the therapeutic and adverse effects of drugs remains a high priority for the pharmaceutical industry, particularly in proving clinical efficacy and safety, and in the evaluation and development of new drugs. Here, an international field of authors have provided a text devoted to the principles and practice of drug evaluation. Emphasis has been given to surrogate end points, peripheral vascular disease, the reliability of collection and interpretation of data and the identification, predictability and interpretation of drug interactions and adverse effects. This volume will be of enormous value to pharmacologists, cardiologists, psychiatrists and haematologists, as well as medical and research staff in industry and academia.