Diamond B I, Albrecht J W
Psychiatry Service, Augusta VA Medical Center, Ga.
Psychopathology. 1987;20 Suppl 1:92-8. doi: 10.1159/000284528.
Among the most controversial issues surrounding the use of generic drugs is the reliance on bioavailability data to approve generic products. Bioequivalence does not necessarily translate into therapeutic equivalence. In some cases, because of the broad interpretation of drug equivalence, patients may not be receiving adequate amounts of medication, while others may be receiving toxic doses. In contrast, rigorous rules exist for the approval of brand-name medications. Resolving the generic drug standard issue by adopting stricter guidelines for generic drug approval based on clinical efficacy and toxicity data rather than on the bioequivalence standard currently being used would more likely result in safer, more effective patient care. Economic burdens for postmarketing research should be shared jointly by the research-oriented and generic drug companies. Such a policy would ensure continued research and new drug development. This paper reviews major scientific, economic, social, and legal issues involved in generic drug use with particular emphasis on the psychotropic drugs.
围绕仿制药使用的最具争议性的问题之一是在批准仿制药时对生物利用度数据的依赖。生物等效性并不一定转化为治疗等效性。在某些情况下，由于对药物等效性的宽泛解释，患者可能没有获得足够剂量的药物，而另一些患者可能正在接受有毒剂量。相比之下，对于品牌药的批准存在严格的规定。通过采用基于临床疗效和毒性数据而非目前使用的生物等效性标准的更严格的仿制药批准指南来解决仿制药标准问题，更有可能带来更安全、更有效的患者护理。上市后研究的经济负担应由以研究为导向的公司和仿制药公司共同承担。这样的政策将确保持续的研究和新药开发。本文回顾了仿制药使用中涉及的主要科学、经济、社会和法律问题，特别强调了精神药物。
