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

chapter 1|11 pages

The Pharmaceutical Background

ByShri C. Valvani

chapter 2|11 pages

The Pharmacological Background

ByB. J. R. Whittle, J. A. Salmon, R. M. Ferris

chapter 3|14 pages

The Metabolic Background

ByWade J. Adams

chapter 4|24 pages

The Toxicological Background

ByAnthony Dayan

chapter 5|20 pages

Animal Tests as Predictors of Human Response

ByPeter I. Folb

chapter 6|6 pages

International Regulatory Requirements

ByF. W. Teather

chapter 7|8 pages

Regulatory Requirements in Japan

ByYasushi Yoshino

part II|39 pages

Organisation and Decision Making

chapter 9|11 pages

The Role of Contract Research Units

ByA. P. Fletcher

chapter 10|6 pages

Decision Points in Human Drug Development

ByRichard D. Mamelok, Jan Lessem

chapter 11|9 pages

Good Clinical Research Practice and Quality Assurance

ByBrian Gennery

part III|55 pages

Ethical and Legal Considerations

chapter 12|11 pages

Ethical Aspects of Research in Healthy Volunteers

BySteven J. Warrington

chapter 13|11 pages

Ethical Aspects of Research in Patients

ByFrank Wells

chapter 14|31 pages

Legal Liabilities in Clinical Trials

ByIan C. Dodds-Smith

part IV|58 pages

Measuring Drug Activity in Man

chapter 15|11 pages

The Assessment of Tolerance and Side-effects in Non-patient Volunteers

ByDerrick Jackson

chapter 16|8 pages

Design of First-administration Studies in Healthy Man

ByColin Broom

chapter 17|6 pages

The Detection and Assessment of Adverse Reactions in Early Phase Patient Trials

ByJan N. Lessem, Richard D. Mamelok

chapter 18|9 pages

The Assessment of Pharmacodynamic Effects

ByJ. D. Harry

chapter 19|14 pages

The Assessment of Pharmacokinetics

ByStephen Toon

chapter 20|8 pages

Radiolabelled Metabolism Studies in Man

ByJ. McEwen, Ian H. Stevenson

part V|97 pages

Assessment of Drug Effects on the Cardiovascular System

chapter 21|12 pages

Non-invasive Measurement of Cardiovascular Response

ByJ. D. Harry

chapter 22|23 pages

Anti-anginal Drugs

ByEdmond Roland

chapter 23|14 pages

Anti-arrhythmic Agents

ByPran K. Marrott

chapter 24|11 pages

Phase I Trials on Anti-hypertensive Drugs

ByJohn R. Cockcroft, David J. Webb

chapter 25|13 pages

Drugs for Heart Failure

ByJanet E. Rush, Mariell Jessup

chapter 26|11 pages

Antithrombotic and Thrombolytic Drugs

ByJ. Ritter

chapter 27|11 pages

Monitoring of Antithrombotic Activity by Platelet Labelling

ByH. Sinzinger, P. Fitscha

part VI|27 pages

Assessment of Drug Effects on the Respiratory System

chapter 28|11 pages

Assessment of Respiratory Responses

ByTimothy W. Evans, Peter J. Barnes

chapter 29|14 pages

Anti-asthmatic Drugs

ByA. M. Edwards

part VII|77 pages

Assessment of Drug Effects on the Central Nervous System

chapter 30|16 pages

Measurement of CNS Effects

ByB. Musch, I. Hindmarch, B. Saletu

chapter 31|12 pages

Drugs in Epilepsy

ByJ. I. Morrow, A. Richens

chapter 32|14 pages


ByB. Musch

chapter 33|12 pages


ByG. R. McClelland, P. J. Summerfield

chapter 34|10 pages


ByJudith L. Siegel, Zofia E. Dziewanowska, Harriet Laine

chapter 35|11 pages

Antipsychotic Agents

ByT. H. Corn, J. R. M. Haigh

part VIII|37 pages

Assessment of Drug Effects on the Gastrointestinal System

chapter 36|24 pages

Measurement of Gastrointestinal Effects

ByK. H. Antonin, P. R. Bieck

chapter 37|11 pages

Anti-ulcer Drugs

ByColin Broom

part IX|25 pages

Assessment of Drug Effects on the Kidney

chapter 38|13 pages


ByJ. McMurray, J. McEwen

chapter 39|10 pages

Measurement of Renal Side-effects

ByAnne Dawnay

part X|31 pages

Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology

chapter 40|11 pages

Abortifacient Drugs

ByM. Bygdeman

chapter 41|18 pages

Oxytocic drugs

ByM. Bamber, M. G. Elder

part XI|47 pages

Assessment of Drug Activity in the Skin

chapter 42|13 pages

Measurement of Skin Response to Drugs

BySam Shuster, P. M. Farr, C. M. Lawrence

chapter 43|20 pages

Drugs for Eczema

ByJohn R. Gibson, Vasant K. Manna

chapter 44|12 pages

Drugs Affecting Hair Growth

ByErvin Novak

part XII|25 pages

Assessment of Drugs Used for the Treatment of Metabolic Disorders

chapter 45|12 pages

Hypolipidaemic Drugs

ByR. H. Jay, D. J. Betteridge

chapter 46|11 pages

Antidiabetic Drugs

ByDaniel C. Howey

part XIII|30 pages

Assessment of the Effects of Chemotherapeutic Agents

chapter 47|4 pages

Antibacterial Drugs

ByA. Pickup

chapter 48|13 pages

Antiviral Drugs

ByWhaijen Soo

chapter 49|11 pages

Anticancer Drugs

ByLee Schacter, Marcel Rozencweig, Claude Nicaise, Renzo Canetta, Susan Kelley, Laurie Smaldone

part XIV|47 pages

Assessment of Drugs Affecting the Inflammatory Process and Pain

chapter 50|17 pages

Drugs Affecting the Immune Response

ByM. Rooney, G. W. Duff

chapter 51|15 pages

Anti-inflammatory Drugs

ByP. S. Helliwell, V. Wright

chapter 52|13 pages


ByR. L. Holland