PubMed · 2586608
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T D Roberts. 1989-11-23. Homoeopathic test.. https://doi.org/10.1038/342350a0
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This paper reviews study procedures for bioequivalence trials, mainly addressed to the New Drug Application (NDA) of generic drugs, strictly referring to EU and USA guidelines on this matter. Specific attention is devoted to the most appropriate experimental designs, the size of the volunteer sample, the ethical issues involved, statistics to assess bioequivalence and the accepted standard format for final research reports. Some aspects which create serious problems in bioequivalence trials, most of which not fully covered by the EU and USA specific guidelines, are comprehensively discussed. These include a) drugs with elevated variability; b) endogeneous substances and the management of baseline value; c) modified release formulations; d) prodrugs; e) restrictions to be contained in forthcoming guidelines on chiral medicinal products; f) superbioavailability; g) drugs with elevated half-life and h) cases in which bioequivalence trials should not be needed. As generic drugs cost less than the innovator product, agencies have facilitated their NDA procedures by requiring a dossier on chemistry and pharmacy and a pivotal bioequivalence study to demonstrate that the generic formulation is fully interchangeable with the innovator product. Bioequivalence is thus the key requirement for an NDA of a generic drug, and trials should be planned, conducted and reported in the most appropriate way. With this in mind, this review is an up-to-date reappraisal that should stimulate the attention of scientists and regulatory authorities on some open questions on bioequivalence.
Americans seem to view medical progress as a citizen's entitlement. They expect, and researchers expect to seek, cures for acquired immunodeficiency syndrome (AIDS), Alzheimer's disease, cancer, and other deadly or incapacitating diseases. Both the public and researchers also seem undaunted by the cost. CDS technologies and biotechnology drugs are making this expectation possible. Still, CDSs may not dispel public resentment over the high cost--and profit--of discovering otherwise welcomed new healing molecules. As noted by 1988 Nobel laureate in medicine, Sir James Black: "I think both the press and industry have failed to communicate to the public that behind every little pill is a vast amount of high technology...." With increasing use of and satisfaction from CDSs, more of these mechanisms, covering a broadening spectrum of uses, will be marketed. Because these products are taken less often, patient compliance is expected to increase. As more CDSs are introduced, dispensing frequency will decline and the complexity of prescription drugs will increase. Pharmacists can take advantage of this trend by expanding their activities in the management their patients' medication use.
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