Principles and Practice of Pharmaceutical Medicine by Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier

By Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier

The lengthy awaited moment version of rules and perform of Pharmaceutical medication offers a useful advisor to all parts of drug improvement and scientific elements of selling. The identify has been largely revised and improved to incorporate the most recent regulatory and clinical advancements. New chapters contain: * eu laws * Ethics of Pharmaceutical medication * Licensing and Due Diligence * PharmacogenomicsEncompassing the total spectrum of pharmaceutical drugs, it's the latest foreign consultant at present on hand.

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No pre-clinical work can be entirely predictive of a successful response in the clinic, and there can, in the end, be no substitute for human testing. Some products fail because of safety problems specific to humans, and some because the early promise of efficacy in model systems is not realized in humans. Those who join this new speciality may come from many medical backgrounds and can well spend much of their time doing things other than pharmacology. In a very real way, those in pharmaceutical medicine are practicing medicine.

To obtain the diploma, the candidate sits written and oral examinations and submits a dissertation. The total number of teaching hours is estimated at 325. Spain The University of Barcelona offers a 2-year nonresidential course consisting of 14 modules between 4-30 hours depending on the subject. Courses are taught at the university one day per week from January to June each year, representing a total of 222 hours of teaching. Written examinations are conducted twice a year. Successful candidates receive a Diploma in Pharmaceutical Medicine.

The CDP defines the critical path for the clinical program and the clinical budget. The CDP also defines investigational drug development assessment and decision points, and the project resource (personnel and budget) estimates. CDPs will cover  preparing the clinical section of IND/CTA submission;  preparing clinical reports needed to support IND/CTA submissions;  clinical research and scientific methodology;  exploratory INDs (in the United States)/pilot efficacy studies;  phase I studies;  phase II studies;  phase III studies;  phase IV studies;  pharmacokinetic and bioavailability studies; 28 CH3 CLINICAL RESEARCH EDUCATION AND TRAINING FOR BIOPHARMACEUTICAL STAFF  dose-ranging studies;  dose-titration studies;  marketing and safety surveillance studies;  studies supporting over-the-counter switches (see a separate chapter in this book).

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