statistical methodology in the pharmaceutical sciences

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Page 1: Statistical methodology in the pharmaceutical sciences

174 Book Reviews

reference to the incidence of illness in both military and civilian aviators.

Pathogenesis of Functional Bowel Disease-Edited by W. J. SNAPE. 368 pp. 1989. Plenum Medical Books, New York. $65.

Abdominal pain, constipation, intestinal irritability, and gut trouble are very common complaints. This book provides a scientific analysis of some of the causes, The topics discussed arc: neuronal control of Cl motility and visceral pain; psychological factors in GI function: central control of GI transit and motility by brain-gut peptides; effect of diet; disorders of GI resulting from drug treat- ment; functional diseases of the oesophagus; causes of disturbed gastric function; small intestine: chronic con- stipation; irritable colon syndrome; functional bowel dis- ease; abdominal pain and biliary tract dysmotility: anal sphincters; bowel disturbance in childhood; surgical treatment. In our life time we put several tons of food, drink and various insults, through our GI system and it is amazing that it functions as well as it does 24 hours every day.

Mammalian Parenting; Biochemical, Neurobiological and Behavioral Determinants-Edited by N. A. KRASNEGOR and R. S. BRIDGES. 502 pp. 1990. Oxford University Press. New York. $75.

The behavior of parents differs from that of other adults. This new behavior pattern is under hormonal, biochemical and social control. This book considered these different aspects, with chapters on hormonal control, aggression, oxytocin, lactation, sexual differentiation of behavior, sen- sory experience, neural control, changes in magnocellular neuronal pathways. parent recognition, male parental be-

haviour. The animals considered range from rats to primates including man.

Statistical Methodology in the Pharmaceutical SciencesEd- ited by D.A. BERRY. 578 pp. 1990. Marcel Dekker, New York. $125 (USA & Canada) $150 elsewhere. $59.75 on order of five or more copies for classroom use.

Most of the problems of experimental design and statistics in pharmaceutical science are presented here: design and analysis of clinical studies; bioavailability; repeated measure design; dose response: population models; linear and non linear regression; cross over versus parallel designs; dropout and related issues; group sequential methods in clinical trials; survival analysis; robust data analysis; categorical data analysis; adverse drug assessment; Bayesian metanaly- sis; inferential problems in postmarketing surveillance. The book provides theory, help in designing the procedures, and indications of what can go wrong. It gives what is required at quite an advanced level.

Statistical Issues in Drug Research and Development-Edited by K. E. PEACE. 366 pp. 1990. Marcel Dekker, New York. $99.75 (USA & Canada). $119.50 elsewhere.

This is one of a series of volumes on applied statistics. The following topics are discussed: analysis and monitor- ing of adverse experiences; two treatment crossover de- signs; active control equivalence studies; optimization in clinical trials and combination drug development; dosing in the elderly; intention to treat in clinical trials; dual control groups in rodent carcinogenicity studies. Laboratory and clinical trials are expensive in time and money and it is well worth spending extra time in the correct design of the trials so as to obtain the maximum benefit from the results, and also avoid errors. This book should help.