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

140pheunder non-trial conditions; term is often used interchangeablewith the term post-marketing surveillance, but also for simple,non-blinded anecdotal, observational or promotional studies;trials exploring new methods of administration, new combinations,new indications etc. are considered within the EC as trials fornew medicinal products; → see also post-approval research.phenotype The observed (physical) expression of the genotype ofan organism, such as its morphology, development, biochemicalor physiological properties, or behavior. Phenotypes result fromthe expression of an organism’s genes as well as the influence ofenvironmental factors and possible interactions between the two;this contrasts with the genotype of an organism (inherited instructionsit carries within its genetic code). Not all organisms withthe same genotype look or act the same way, because appearanceand behavior are modified by environmental and developmentalconditions. Also in the same way, not all organisms that look alikenecessarily have the same genotype.physician investigator Physician taking a dual role as researcher andinvestigator in academic studies; → see also investigator, sponsorinvestigator.phytomedicines syn. herbal medicines; medicines derived fromplants; some health authorities review p. on the basis of singleplants (e.g. Germany) as well as of combinations (e.g. France), otherauthorities on the basis of single products (e.g. UK); in Europe,Germany is at present the largest market for p. covering about70% of the total consumption followed by France; within the EECaround 1,400 herbal drugs are used, roughly half of them are POM;about 25% of OTC products are herbal medicines; → see also foodsupplement, functional food, self-medication, traditionalherbal medicinal product.pill-counting → see compliance.pilot study syn. preliminary study, exploratory study; often performedto estimate treatment effects or recruitment rates, totest out the practicability of new methods and the feasibility orsuitability resp. of a protocol to a larger clinical project, in orderto select the most suitable design and to ensure adequate recruitment;sometimes studies with a poor design are also called p.s. inorder to avoid criticism; → see also explanatory trial, pivotalstudy.pivotal data Data from clinical trial reports providing substantiveevidence of efficacy and safety on which a new drug applicationcan be judged; → see also supportive data.pivotal study Key study for primary evidence of efficacy; → see alsopilot study, supportive data.