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

149proprietary medicinal product (PMP) opp. generic.proprietary name → see trade name.prospective study opposite: restrospective study; trial in which subjectsare documented and monitored in accordance with a protocolwhich has been set-up before recruitment.protein Proteins are biological effector molecules encoded by an organism’sgenome. A protein consists of one or more polypeptidechains of amino acid subunits. The functional action of a proteindepends on its three dimensional structure, which is determinedby its amino acid composition and any post-transcriptional modifications;→ see also protein binding.protein binding Many drugs bind to plasma proteins but only theunbound fraction is available for diffusion to the site of action;drugs with a high p.b. have a small volume of distribution; theydo not easily penetrate the cerebrospinal fluid and are also not easilyremoved by extracorporeal dialysis; acidic substances bind toalbumin, basic substances to alpha-1-glycoprotein; p.b. can be affectedby diseases (e.g. hypoalbuminaemia increases the unboundfraction) but also by comedication (displacement of a drug by anotherdrug which binds stronger); → see also pharmacokinetic.proteomics The development and application of techniques used toinvestigate the protein products of the genome and how they interactto determine biological functions; science of “proteoms” i.e.looking at the entire set of proteins, protein structure and functionof an organism; applications are in the identification of diseasemarkers for diagnose and drug targets; → see also gene, genomics,gene therapy.protocol syn. study plan, investigational plan; a document or manualof operation resp. which states the rational, objectives, statisticaldesign, methodology etc. of a trial, with the conditions under whichit is to be performed and managed; EC (III): “The p. must, whererelevant, contain the following … items: general information, justificationand objectives, ethics, general time schedule, general design,subject selection, treatment, assessment of efficacy, adverseevents, practicalities, handling of records, evaluation, statistics,financing, reporting, approvals, insurance, etc., summary, supplements,references”; → see also addendum, amendment.protocol deviation Usually minor non-compliances with the protocolin contrast to protocol violations.protocol violation Usually major deviations from a protocol in contrastto protocol deviations.p-value (p) Chance of obtaining the observed result or one more extremeif one assumes that the effects of the treatments are equal;p is therefore the confidence with which the null-hypothesis ispva