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      Book

      Early Phase Drug Evaluation in Man
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      Book

      Early Phase Drug Evaluation in Man

      DOI link for Early Phase Drug Evaluation in Man

      Early Phase Drug Evaluation in Man book

      Early Phase Drug Evaluation in Man

      DOI link for Early Phase Drug Evaluation in Man

      Early Phase Drug Evaluation in Man book

      Edited ByJohn O’Grady, Otto I. Linet
      Edition 1st Edition
      First Published 1990
      eBook Published 31 March 2020
      Pub. Location Boca Raton
      Imprint CRC Press
      DOI https://doi.org/10.1201/9780367812454
      Pages 737
      eBook ISBN 9780367812454
      Subjects Bioscience
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      O’Grady, J., & Linet, O.I. (Eds.). (1990). Early Phase Drug Evaluation in Man (1st ed.). CRC Press. https://doi.org/10.1201/9780367812454

      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.

      TABLE OF CONTENTS

      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 8|11 pages

      The Organisation of New Drug Evaluation in the Pharmaceutical Industry

      ByYves Champey

      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

      Anxiolytics

      ByB. Musch

      chapter 33|12 pages

      Hypnotics

      ByG. R. McClelland, P. J. Summerfield

      chapter 34|10 pages

      Antidepressants

      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

      Diuretics

      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

      Analgesics

      ByR. L. Holland
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