220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

137and the application of this information in clinical practice; sciencestudying genetic basis for diseases such as the correlation betweengenes, phenotypes and diseases; currently only the function ofabout 2,000 genes is known out of the potential of 100,000; → seealso ethnic differences, gene therapy, genomics, metabolism,pharmacogenetics.pharmacokinetic Science dealing with the absorption, distribution,metabolism, and excretion (adme) of drugs in the body, usuallyconducted as single dose studies or steady state study; populationpharmacokinetics takes into account that drugs behave differentlyin different populations, e.g children or old persons; → seealso area under the curve, bioavailability, clearance, firstpasseffect, half life, kinetic, partition coefficient, proteinbinding, volume of distribution.pharmacokinetically guided dose escalations (PGDE) Dose escalationstrategy in phase I oncological trials; it is based on the hypothesisthat the area under the plasma concentration-time curve(AUC) at the LD-10 in mice and at the MTD in man are similar (patient’sAUCs must be measured and be available rapidly); → seealso continuous reassessment method (CRM), dose escalation,fibonacci search scheme, maximum tolerated systemicexposure (mtse).pharmacology Science dealing with effects of a drug on organs orbody systems; this covers the mutual interaction of chemicalagents and biological systems, the nature of the action (i.e., thenature of the altered bodily response), the site of action, and themechanism involved.pharmacopoeia Regularly updated information on drugs in bookform (standards of quality specifications such as purity, identitya.s.o.); quality of commercialized medicinal products mustcomply with these standards; examples: British P., British HomoeopathicP., US P., European P; the European P. has been elaboratedby over 20 European countries including Member States ofthe European Community and has binding character, reinforcedby EC directives.pharmacovigilance Def.: “science and activities relating to the detection,assessment, understanding, and prevention of adverseeffects or any other drug related problems” (WHO); “the processof monitoring, evaluating and improving the safety of medicinesin use” (EMEA); confounded sometimes with post-marketingsurveillance; system for collecting spontaneous reports onadverse reactions, assessing causality and risks; major methodsare: spontaneous, voluntary reporting schemes (e.g. yellowcard system), intensive hospital monitoring, use of official statis-pha