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a. pharmacologie a.1 pharmacodynamic cette étude doit être effectuée en suivant deux principes distincts.
the study of pharmacodynamics shall follow two distinct lines of approach:

dans la mesure du possible, les études de pharmacodynamic et de pharmacoci nét i que des médicaments radioactifs doivent être réalisées sur des malades sélectionnés de façon appropriée plutôt que sur des volontaires sains.
whenever possible, initial pharmacodynamic and pharmacokinetic studies with radiopharmaceuticals should be performed in suitable patients, rather than in healthy volunteers.

la démonstration d'un effet pharmacodynamic chez l'homme ne suffit pas à elle seule à justifier des conclusions quant à un éventuel effet thérapeutique.
demonstration of pharmacodynamic effects in human beings shall noe in icself be sufficienc co justify conclusions regarding any particular potential therapeutic effect.

on entend par pharmacodynamic l'étude des variations provoquées par le medicament dans les fondions des organismes, que celles-ci soient normales ou expérimentalement altérées.
in the first case, the pharmacodynamic study shall demonstrate those interactions which might make the combination of value in therapeutic use.

on entend par pharmacodynamic l'étude des variations provoquées par le médicament dans les fonctions de l'organisme, que celles-ci soient normales ou expérimentalement altérées.
pharmacodynamics means the study of the variations caused by the medicinal product in the functions of the organs, whether these functions are normal or experimentally modified.

note for guidance on clinical investigation of medical products in the treatment of obsessive-compulsive disorder addendum on acute cardiac failure to the cpmp note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia note for guidance on clinical investigation of steroid contraceptives in women revision of note for guidance on evaluation of new anti-bacterial medicinal products (cpmp/ewp/558/95) and note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial medicinal products
cpmp safety working party document title position paper on the non-clinical safety studies to support clinical trials with a single low dose of a compound note for guidance on specification limits for residues of metal catalysts note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance:annex on non-clinical and clinical considerations