[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.
D000818:Animals; D001682:Biological Availability; D001702:Biopharmaceutics; D004304:Dosage Forms; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D004355:Drug Stability; D064420:Drug-Related Side Effects and Adverse Reactions; D004992:Ethics, Medical; D005860:Germany, West; D006801:Humans; D007258:Informed Consent; D007700:Kinetics; D007880:Legislation, Drug; D010592:Pharmaceutic Aids; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D012107:Research Design; D013810:Therapeutic Equivalency
D004304:Dosage Forms; D010592:Pharmaceutic Aids; D004364:Pharmaceutical Preparations
Bioverfügbarkeit, Wirksamkeitsnachweis und Folgerungen für die Arzneimittelgesetzgebung