PubMed · 5662712
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H B Richerson. 1968. Expectorants.. https://pubmed.ncbi.nlm.nih.gov/5662712/
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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.
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Centralized intravenous additive services (CIVA) are becoming an essential component of hospital pharmacy services in the U.K. This review explores the background to their development, indicating how aseptic services commenced with total parenteral nutrition, developed further with cytotoxic drug preparation and is now progressing, in an increasing number of hospitals, to a full range of parenteral drug services. The benefits of pharmacy-operated provision of injections in ready-to-administer forms are described. The operation of such services is then considered in detail. A brief discussion of the types of service that can be operated is followed by consideration of staffing, facilities, methods of operation, technical support and documentation. National guidelines in the U.K. and U.S.A. are compared, since these have a major influence of the nature of CIVA service operation. The issues associated with the stability of reconstituted and repackaged injectables are discussed, together with how our knowledge can be used in the assignment of shelf lives to pharmacy-prepared intravenous additives. The review concludes with a brief assessment of future trends and changes likely to affect intravenous services provided under pharmacy control.