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Results for “Legislation, Drug”

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At least 19 recordsLinked to original sources
PubMed1976

[Bioavailability, proof of efficacy and their consequences for drug legislation (author's transl)].

Drugs should be effective for the indicatons stated, they should not involve risks which would not be justified in relation to their benefit and they should be of the necessary quality. It is the objective of drug legislation to warrant these requirements in its area of jurisdiction. It has become a necessity to revise current legislation; it is going to be replaced by a new law. A corresponding bill is being considered by Parliament at present. The present and the future legal situation with regards to proof and safeguarding of the bioavailability of pharmacologically active substances and the necessary prerequisites and rules for the procedure of clinical testing of drugs to prove their efficacy and safety is described.

Animals↗
PubMed1983

A survey of generic drug legislation and geriatric pharmacotherapy: opinions of those who generate the literature.

Eighty-three authors who had published papers within the last five years on pharmacologic therapy in aged humans were surveyed by written questionnaire and their responses analyzed. The survey sought opinions on the scientific, clinical, and social context of legislation on drug product selection (generic legislation) and its relationship to geriatric pharmaco-therapeutics. The majority of respondents: 1) were generally unaware of the content of the clinical or scientific opinion offered on the subject of drug product selection as part of the legislative process; 2) felt that potential cost savings for elderly people was a factor in advancing this legislation; 3) wrote prescriptions so that product substitution could occur despite their ambivalence about such substitutions and about the knowledge of pharmacist and physician concerning product substitution and drug equivalence for the elderly. Clinical pharmacologists and geriatricians, however, were less likely than other respondents to permit substitution. The implications of current opinions and practices regarding drug product selection for geriatric patients are discussed.

Attitude of Health Personnel↗