ABSTRACT

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.

part I|96 pages

Preliminaries to Testing of Drugs in Man

part III|55 pages

Ethical and Legal Considerations

part V|97 pages

Assessment of Drug Effects on the Cardiovascular System

part VI|27 pages

Assessment of Drug Effects on the Respiratory System

chapter 29|14 pages

Anti-asthmatic Drugs

part VII|77 pages

Assessment of Drug Effects on the Central Nervous System

chapter 30|16 pages

Measurement of CNS Effects

chapter 31|12 pages

Drugs in Epilepsy

chapter 32|14 pages

Anxiolytics

chapter 33|12 pages

Hypnotics

chapter 35|11 pages

Antipsychotic Agents

part VIII|37 pages

Assessment of Drug Effects on the Gastrointestinal System

chapter 37|11 pages

Anti-ulcer Drugs

part IX|25 pages

Assessment of Drug Effects on the Kidney

chapter 38|13 pages

Diuretics

chapter 39|10 pages

Measurement of Renal Side-effects

part X|31 pages

Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology

chapter 40|11 pages

Abortifacient Drugs

chapter 41|18 pages

Oxytocic drugs

part XI|47 pages

Assessment of Drug Activity in the Skin

chapter 43|20 pages

Drugs for Eczema

chapter 44|12 pages

Drugs Affecting Hair Growth

part XII|25 pages

Assessment of Drugs Used for the Treatment of Metabolic Disorders

chapter 45|12 pages

Hypolipidaemic Drugs

chapter 46|11 pages

Antidiabetic Drugs

part XIII|30 pages

Assessment of the Effects of Chemotherapeutic Agents

chapter 47|4 pages

Antibacterial Drugs

chapter 48|13 pages

Antiviral Drugs

part XIV|47 pages

Assessment of Drugs Affecting the Inflammatory Process and Pain

chapter 51|15 pages

Anti-inflammatory Drugs

chapter 52|13 pages

Analgesics