Published October 1985
by S Karger Pub .
Written in English
|The Physical Object|
|Number of Pages||236|
Get this from a library! Methodology of clinical drug trials. [Alain Spriet; Thérèse Dupin-Spriet; Pierre Simon, M.D.] -- This book is an updated version of the previous work by the same authors which now is out of print (Edition ). This manual contains a thorough and didactic presentation of methods currently used. Clinical trials involving new drugs are conducted in a series of sequential steps, called phases to determine the safety and tolerability of the new drug and the efficacy against the target disease (s). Each phase is designed to answer a separate research question and is a separate clinical trial. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the. Depending upon the objective, clinical trial is conducted either on healthy volunteers or on volunteer patients. Healthy volunteers are generally included in such trial that determines pharmacokinetics, tolerability, safety and even efficacy of certain types of drugs (e.g. hypoglycemic, hypnotic, diuretic etc.).
Clinical research plays a vital role in the drug development process because approval of a drug by the Food and Drug Administration (FDA) requires clinical trials to dem- onstrate the safety and efficacy of pharmaceutical Size: 4MB. Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientiﬁ c quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research. Clinical trials are an integral part of new product discovery and development and are required by the Food and Drug Administration before a new product can be brought to the market. Clinical trials are a way to test new methods of diagnosing, treating, or preventing health conditions. The goal is to determine whether something is both safe and : Jill Seladi-Schulman Phd.
As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. “‘New Drug Development: An Introduction to Clinical Trials, 2 nd Edition’ is a solid introduction to the process of drug development, with an emphasis on clinical research, especially the statistical aspects. It is ideal for readers interested in clinical research within the broader : Springer-Verlag New York. Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. Clinical trials gained importance in medical research after World War II, when there was a rapid increase in drug development and research. Psychopharmacology is a field that reflects the marked increase in using clinical by: