By A. F. Cohen, J. Posner (auth.), Adam Cohen, John Posner (eds.)
Following the good fortune of the 1st variation, released in 1995, this totally rewritten A consultant to medical Drug learn - moment Edition has been tailored to the latest guidance and advancements within the box. It maintains to supply a wealth of sensible suggestion, starting from the belief of an concept, making plans a examine and writing a protocol, via to the behavior of a examine, information assortment and research, and ebook. It tells investigators what details they need to anticipate sponsoring businesses to supply, relatively while there's basically restricted info on hand a couple of new drug. It additionally explains what the corporate can anticipate of investigators, together with the necessities of `good scientific practice'. in contrast to different at present to be had texts on scientific trials and pharmaceutical medication, AGuide to medical Drug Research concentrates at the wishes of the practicing clinician and examine staff. it isn't constrained to drug research, and is correct to all these inquisitive about scientific study in quite a few settings.
Audience: Required interpreting for scientific researchers and others concerned as investigators in a drug undertaking, frequently backed by means of a pharmacuetical corporation, plus brokers of the sponsoring businesses themselves.
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Extra info for A Guide to Clinical Drug Research
Pre-clinical section A brief explanation of some of the terminology used in pharmacology sections is presented at the end of this chapter. However, you should refer to some of the standard texts for further information. Pharmacology • In-vitro Biochemical experiments are conducted to demonstrate activity, potency and specificity of the study drug. Experiments are carried out on isolated tissue preparations to show the potency, specificity, selectivity, duration of action and tissue concentration-response relationships.
Information on any comparator agents used must also be provided. The sponsor should provide the investigator with the protocol and an up-to-date Clinical Investigators Brochure (CIB), and should provide sufficient time for the investigator to review this information. The sponsor must also inform the investigator of any relevant new information arising during the trial. • Investigator's responsibilities The investigator should be thoroughly familiar with the appropriate use of the investigational product (and any comparators), as described in the protocol, in the current CIB, in the product information, and in other information sources provided by the sponsor.
Mass-balance studies using radiolabelled compound will determine the extent to which the parent compound is metabolised, and the predominant route of excretion. Can all or most of the administered dose be accounted for in the urine and faeces? Look for differences in each of the pharmacokinetic parameters in sub-groups of the population studied; are there any sex or age differences for example? Do any concomitant medications result in an altered pharmacokinetic profile of the drug? At a later stage of drug development these answers may be available from population pharmacokinetic analyses, using limited samples from patients in large scale Phase III trials.
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