Spino M
Faculty of Pharmacy, University of Toronto, Ont.
CMAJ. 1989 Nov 1;141(9):883-7.
I have attempted to address some critical issues relating to the introduction of generic aerosol bronchodilators in Canada. I approached Genpharm to obtain information on the data submitted to the HPB, including the number of subjects involved, but the company refused to divulge this information because it was concerned about the use of such information by its competitors. In addition to the in-vitro testing conducted by the HPB, should a single pharmacodynamic study be sufficient to demonstrate the safety and efficacy of a drug that serves such a critical role in the prevention of serious illness and possibly death? If so, what will constitute the minimum requirements for the design of such a study? In general, what should be the minimum standards required for safety, efficacy and bioequivalence of aerosol bronchodilators? The next phase rests with the provincial governments. What criteria will they use to determine whether a generic aerosol bronchodilator will be considered bioequivalent? It is essential that the criteria for bioequivalence be developed by experts, and ideally those criteria should be agreed upon and accepted by federal and provincial regulatory bodies before a product is given the status of bioequivalence. Unless such a step is taken it will be difficult to have confidence that products can be considered interchangeable. The issue of interchangeability of aerosol bronchodilators demands immediate attention. Regulatory agencies are caught between those groups with vested interests on both sides. Since patients will either benefit or suffer as a consequence of regulatory decisions, action must be taken to ensure that the best decisions are made. Scientists, clinicians and government officials should convene as soon as possible to formulate a satisfactory approach to this problem of interchangeability. The medical and pharmaceutical professions need reliable information, and patients should not be denied less expensive generic drugs if it can be determined that they are comparable to the innovator's product.
我已尝试探讨一些与在加拿大引入非专利气雾剂支气管扩张剂相关的关键问题。我与Genpharm公司联系，以获取提交给加拿大卫生部的数据信息，包括所涉及的受试者数量，但该公司拒绝透露此信息，因为它担心其竞争对手会利用这些信息。除了加拿大卫生部进行的体外测试外，一项药效学研究是否足以证明一种在预防严重疾病甚至可能死亡方面起着关键作用的药物的安全性和有效性？如果是这样，此类研究设计的最低要求是什么？一般而言，气雾剂支气管扩张剂在安全性、有效性和生物等效性方面的最低标准应该是什么？下一阶段取决于省政府。他们将使用什么标准来确定一种非专利气雾剂支气管扩张剂是否被视为生物等效？至关重要的是，生物等效性标准应由专家制定，理想情况下，在一种产品获得生物等效性地位之前，这些标准应得到联邦和省级监管机构的认可和接受。除非采取这一步骤，否则很难相信产品可以被视为可互换的。气雾剂支气管扩张剂的可互换性问题亟待关注。监管机构夹在双方都有既得利益的群体之间。由于监管决策的结果患者要么受益要么受损，必须采取行动以确保做出最佳决策。科学家、临床医生和政府官员应尽快召开会议，为这个可互换性问题制定一个令人满意的解决方案。医疗和制药行业需要可靠的信息，如果能够确定非专利药物与创新产品相当，患者不应被剥夺使用价格较低的非专利药物的权利。
