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

128outintroduced in Japan (limit: Japan: 50,000 cases/year), Singaporeand Australia; the estimated number of such “rare” diseases isabout 5,000; in Japan regulations will facilitate also developmentof o.d.s and medical devices if the target population is estimatedto be less than 50,000 cases and development medically necessary(special tax incentives, preferential regulatory review, re-examinationperiod for post-marketing surveillance and adverse reactiondata extended from up to 6 years to up to 10 years thereforegiving a longer period of marketing exclusivity); in US, drugs fordiseases affecting more than 200,000 subjects may receive orphandrug status if there is no reasonable expectation that the costs ofdeveloping and making available in the US a drug for such diseaseor condition will be recovered in the US; in most countries,application fees can be waived or are considerably reduced foro.d.; in some countries, there are also tax reductions as incentives;→ see also expanded-access program, marketing authorisation,prevalence rate.outcome measurement syn. outcome variable; → see age-specificrate, endpoint, pharmacoeconomics.outcomes research Research into health behaviour that reveals bestmedical practice based on evidence (evidence based medicine);→ see also disease management, outcome measurement, qualityof life, surrogate.outliers Data that have been incorrectly recorded; usually all datawhich are out of a range of twice the standard deviation arecarefully looked at; care must be taken that only true errors inmeasurement are removed in order to rectify any data; as a rule ofthumb only one o. may be excluded for each group of 40 samples,otherwise the method should be suspect; data are checked by examiningthe frequency distribution for impossible or outlyingvalues; doubtful o. should be subject of a blind review process;→ see also data, errors, fraud, raw-data.outpatient Patient who is not hospitalized for treatment (opp. inpatient);considerable ingenuity is necessary in the design and executionof outpatient studies to circumvent typical difficulties ase.g. observations at less frequent intervals requiring substantialretrospection on the part of the patient, less tight control for intakeof interfering medications or compliance with prescription,higher rates of drop-outs, a.s.o.; some of the difficulties may beovercome by utilisation of patient report forms.overdose → see adverse reaction, defined daily dose, significantoverdose.overhead Regular expenses needed to operate a business, includingthe costs of rent, utilities, up-keep, and taxes.