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

147gible to apply for a price increase, those exceeding the upper limitby 25% must either pay back the excess to the DoH or reduce theprices; the PPRS caps also selling and promotion expenditures to9% and information expenditures to 1.6% of overall sales; → seealso health care costs, reference pricing.primary endpoint Also called key data, key (efficacy) criteria; variableused for sample size calculation; usually hard endpoints,objective endpoints; outcome variables which are considered asespecially important for postulating a clinically meaningful difference(death, stroke, reinfarction, time to relapse, infection rateetc. or biological markers specific for the underlying disease as e.g.antigen levels, which can be used as surrogate endpoints); ideallythey should also be easy to measure with both precision andaccuracy, and clearly important to the patient.priming dose → see loading dose.principal investigator (PI) → see investigator.prion Postulated since 1969, but unproven causative agent of transmissiblespongioform encephalopathies (TSE), such as Creutzfeld-Jakob disease (CJD) in humans, bovine spongioform encephalopathy(BSE) in cattle, and scrapie in sheep.probability → see significance level.procedures EC: “description of the operations to be carried out, theprecautions to be taken and the measures to be applied directly orindirectly related to the manufacture of a medicinal product”.prodrug Pharmacologically inactive form of a drug in an oral pharmaceuticalformulation; after contact with intestinal secretionsthe active form is released by splitting of chemical bonds; e.g. ester-groupsin bacampicillin (prodrug of ampicillin, an antibiotic)or ramipril (an ACE-inhibitor); prodrugs have in general a betterbioavailability than the parent substances and therefore lessgastrointestinal side effects.production EC: “all operations involved in the preparation of a medicinalproduct, from receipt of materials, through processingand packaging, to its completion as a finished product”.product → see drug, proprietary medicinal product, essentiallysimilar product, therapeutic equivalent.product liability EC (I): the producer of a medicinal product “shallbe liable caused by a defect in his product”; “the injured personshall be required to prove the damage, the defect and the causalrelationship between defect and damage”; → see also compensationfor drug induced injury, indemnification, insurance.product licence (PL) Approval to advertise, supply and sell a medicinalproduct; products that have been granted a licence carry anumber beginning with the letters PL on the manufacturer’s pack.pro