Early Phase Drug Evaluation in Man

O'grady, John O'Grady, Otto Linet

• Publisher: CRC Press
• Year: 2020
• Print ISBN: 9780849377082
• eBook ISBN: 9781000725599
• Topic: Medicine
• Subtopic: Medical Theory, Practice & Reference

Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

Index

Abortifacient drugs 521–531

acceptability of treatment 528–529

definition of study population 522–523

evaluation of treatment outcome

efficacy 526–527

side–effects and complications 527–528

interaction with other drugs 528

mode of action 523–525

oxytocics 540–542

Abortion

clinical evaluation of oxytocic drugs in 540–542 see also Abortifacient drugs

Absorption of drugs 30–32

antidiabetics 618–619

assessment of 31–32

application of drugs into large bowel during colonoscopy 466–467

buccal absorption 467

HF capsule 466

intubation techniques 465–466

patients with artificial stoma 467

factors affecting 31

Abuse potential, anxiolytics 417–418

Academic research, ethics of patient studies 156

Adolescent acne, drug treatment of

clinical response 559

measurement of sebum excretion rate 559

Adverse effects, see Tolerance and side–effects

Age

and Phase I testing of antihypertensive drugs 306–307

and testing of anti-asthmatic drugs 367

AIDS research, ethics of 157

Alcohol consumption, and Phase I testing of antihypertensive drugs 308

Analgesics 558, 689–701

early studies of efficacy in patients 693–697

recommendations 697

useful paradigms for novel analgesics 694–697

acute pain 694–695

chronic pain 695–696

ethical considerations 689

later clinical

pharmacological

studies 698

studies of efficacy in volunteers ...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Table of Contents
• Foreword
• Preface
• I. Preliminaries to Testing of Drugs in Man
• II. Organisation and Decision Making
• III. Ethical and Legal Considerations
• IV. Measuring Drug Activity in Man
• V. Assessment of Drug Effects on the Cardiovascular System
• VI. Assessment of Drug Effects on the Respiratory System
• VII. Assessment of Drug Effects on the Central Nervous System
• VIII. Assessment of Drug Effects on the Gastro-intestinal System
• IX. Assessment of Drug Effects on the Kidney
• X. Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology
• XI. Assessment of Drug Activity in the Skin
• XII. Assessment of Drugs Used for the Treatment of Metabolic Disorders
• XIII. Assessment of the Effects of Chemotherapeutic Agents
• XIV. Assessment of Drugs Affecting the Inflammatory Process and Pain
• Index