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

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

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

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181tablet → see formulation.tablet excipients In addition to the active drug, medicinal products<strong>of</strong>ten contain a number <strong>of</strong> other substances, e.g. for improvingbioavailability such as disintegrants (e.g. starch), for tastemasking and lubrication to ease swallowing (e.g. coats <strong>of</strong> sugar,cellulose, polymers in film-coated tablets), or simply substanceswhich facilitate production such as binders (e.g. cellulose derivatives),glidants (colloidal silica) or diluents (lactose, crystalline cellulose);→ see also formulation.tachyphylaxis Decreasing response to a drug with repeated doses;this develops, in contrast to tolerance, within a very short time(minutes or hours) as e.g. for histamine.temporality Exposure to a cause must preceed the effect <strong>of</strong> the exposure.termination visit syn. close out visit; last visit <strong>of</strong> a monitor or clinicalresearch associate to a centre in order to collect all remainingcase report forms (CRF), drug samples, unused CRFs orconsent forms and usually also the investigator’s brochure; atthis occasion also financial and analysis/reporting aspects may bediscussed with the trialist and her/his staff.test article Any substance or device for human use which is subjectto premarket approval; although regulations differ between countriesmost <strong>of</strong> them exclude e.g. cosmetics from national drug regulations.test article accountability (TAA) American term for drug accountability.test-retest Use <strong>of</strong> the same or questionnaire in the same patient atdifferent periods <strong>of</strong> time to assess validity <strong>of</strong> measurement <strong>of</strong> exposure.therapeutic equivalent Dosage form exhibiting the same efficacy(toxicity) when administered in the same appropriate dosage regimen;EC: “A medicinal product is therapeutically equivalent withanother product if it contains the same active substance or therapeuticmoiety and clinically shows the same efficacy and safetyas that product, whose efficacy and safety has been established”;→ see also biologic equivalent, essentially similar product,pharmaceutical equivalent.therapeutic index Ratio <strong>of</strong> the therapeutic dose (ED 50) to the toxicdose (LD 50); → see also toxicity tests.therapeutic potential Some health authorities provide acceleratedapproval programs for new drugs, depending on their therapeuticor innovative potential; for the FDA classification as “P” (priority)or “S” (standard) does exist.therapy management → see disease management.the

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