Drugs between Research and Regulations: Proceedings of the by Prof. Dr. med. G. Zbinden (auth.), Dr. med. C. Steichele,

By Prof. Dr. med. G. Zbinden (auth.), Dr. med. C. Steichele, Prof. Dr. med. U. Abshagen, J. Koch-Weser M. D. (eds.)

Franz Gross died all of sudden in the course of arrangements for the assembly. He might have taken nice excitement in summarizing during this preface the goals and result of a meeting which so in actual fact bore his imprint as Chairman of the clinical software Committee. His unexpected passing away is deeply regretted by means of we all: organizers, audio system and individuals. We drastically recognize him for his unparalleled skills, his effect on technological know-how and his features as a man or woman. He supplied the impulse for a good balanced and topical clinical application. We as a result commit the lawsuits of this symposium to his reminiscence. Munich used to be the 5th in a standard line of overseas conferences of pharmaceutical physicians held at three-year periods, beginning in London in 1972 ('International features of Drug evaluate and Usage'), and by way of Florence in 1975 (,Rationality of Drug Development'), Brussels in 1978 (,Pharmaceutical medication - the Future') and Paris in 1981 ('Drug defense -;- growth and Controversies'). This fifth assembly mentioned advancements in drug improvement and alertness and tested the influence of regulatory activities.

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Extra resources for Drugs between Research and Regulations: Proceedings of the 5th International Meeting of Pharmaceutical Physicians Munich, October 14–17, 1984

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27 So the scientific and statistical aspects must be correct for a clinical trial to be of general value; consider first four aspects of the scientific method that Vere considers to be advantageous. 1. It gives the greatest ability to compare knowledge gained in different places at different times. It is "updatable". 2. It makes the detection and removal of bias including personal bias easier than any other method. 3. Its results are continuously corrigible because it works in corroboration and falsification of theories (Popper 1980).

He felt this was important because otherwise it might influence the outcome of following studies and prompt a decision to proceed along certain lines at the expense of others. This to a certain extent is also supported in a paper on multiplicity by Tukey, who felt that the use of investigative tools prior to strictly controlled clinical trials with ethical constraints may predetermine the outcome and direct the analysis and design along certain set paths which might not necessarily be correct or beneficial.

If this were the best species available, we should consider performing routine chronic toxicity studies in this one species only, be it rodent or non-rodent. This in turn Table 2. Information from chronic toxicity studies Reason: information on repeated dosing range finding for carcinogenicity range finding for reproduction range finding for mutagenicity control of pharmacological actions organ toxicity, behavior, hyperplasia, tumors Describe: morbidity> mortality dose response curve Table 3. ) non-rodents Route: (proposed) Doses: (3) plus control 23 implies supportive (preliminary) studies in other species.

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