Cromie B W
Postgrad Med J. 1974 Feb;50(580):103-6. doi: 10.1136/pgmj.50.580.103.
Drugs that do not have a critical dosage and are commonly used together, can justifiably be combined in a single product. Such combinations are more convenient to doctor and patient and have reduced risk of treatment error and drug interaction. Combination products include more than one active drug, each of which has its own chemical and physical properties, so that they are complex formulations. Copies of combination products are, therefore, even less likely to have comparable performance than copies of single drugs. Generic copies are encouraged by pharmacopoeial monographs and the current inclusion of complex formulations and combinations in the BP may allow a new era of clinical non-equivalence from products considered to be generically equivalent.
没有临界剂量且通常一起使用的药物,可以合理地组合在单一产品中。这种组合对医生和患者来说更方便,且治疗错误和药物相互作用的风险降低。复方制剂包含一种以上活性药物,每种药物都有其自身的化学和物理性质,因此它们是复杂的制剂。因此,复方制剂的仿制药比单一药物的仿制药更不可能具有可比的性能。药典专论鼓励仿制,而目前英国药典中收录复杂制剂和复方制剂可能会开启一个临床不等效的新时代,涉及被认为是仿制药等效的产品。