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Non-Procrustean pathways for complex generic drugs development

机译：非促进仿制药物发展的非促进途径

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Overall, legal texts tend to be abstruse and, even if one is proficient in Legalese, their interpretation may be dubious offering more than one equally plausible path forward. The situation is somewhat more straightforward in the pharmaceutical arena, not only in terms of language but also for setting clear regulatory standards. The downside of this strategy is the overuse of one-size-fits-all (OSFA) approaches. Even though OSFA approaches ensure harmonization throughout the regulatory decision-making process, they may not be adequate for all the cases. Paraphrasing the famous Albert Einstein quote of the Occam's razor principle (i.e., problem-solving/logical principle that, when you have two competing theories that make exactly the same predictions, the simpler one is the better, also known as the 'law of parsimony), we may state that "regulatory guidelines should be made as simple as possible but not any simpler'. In fact, during a 2006 Advisory Committee for Pharmaceutical Science meeting at the US FDA, Leslie Benet declared the then current OSFA-based bioequivalence (BE) guidelines to be Procrustean [1]. In Greek mythology, Procrustes was a robber who killed his victims in the most cruel and unusual way. He made them lie on an iron bed and would cut off body parts of the people who were too large or stretch people who were too short [2]. According to the Merriam-Webster dictionary, Procrustean takes no account of individual differences, but makes everyone the same. However, it is worth noting that the regulatory paradigm in the realm of generic drugs has advanced toward non-Procrustean approaches, for example, with the Biopharmaceutics Classification System-based biowaiver decisions, as well as reference-scaled average BE for highly variable drugs, keeping the pace with the modern era of individualized and precision medicine [3,4]. Demonstration of therapeutic equivalence for so-called 'complex generics' however remains challenging, as recendy stated by the FDA Commissioner [5]. In order to approach these more complex scenarios, respective cases can be subdivided into four different categories: complex routes of delivery; complex formulations; complex drug substances and complex drug—device combination.
机译：总体而言，法律文本往往是深奥，即使一个人精通合法，他们的解释也可能是可疑的，前进的同样合理的道路。在制药领域的情况有所更加直接，不仅在语言方面，而且还用于制定明确的监管标准。这种策略的缺点是过度使用单尺寸适合 - 所有（OSFA）方法。尽管OSFA方法在整个监管决策过程中确保协调，但它们可能对所有案例可能不足。释放着名的Albert Einstein引用春天的剃刀原则（即解决问题/逻辑原则，当您有两个竞争理论做出完全相同的预测时，更简单的是更好，也称为“定义法则” ），我们可能说，“监管指南应尽可能简单，但不是任何更简单的人。事实上，在美国FDA的2006年药学系会咨询委员会期间，Leslie Benet宣布当时的基于OSFA的生物等效（是procrustean的指导方针[1]。在希腊神话中，普鲁斯特是一个强盗，以最残忍和最不寻常的方式杀死了他的受害者。他让他们躺在铁床上，也会切断那些人的身体部位太短的大或伸展的人[2]。根据Merriam-Webster字典，Procrustean不考虑个人差异，但使每个人都同样。然而，值得注意的是，重新中的监管范式通用药物的ALM已经向非营利性方法推进，例如，与基于生物制药学分类的生物广告主义者的生物广告者决策，以及参考分级平均值，适用于高度可变的药物，保持与个性化和精密药物的现代时代的步伐[3,4]。然而，所谓的“复杂普遍”的治疗当量的示范仍然具有挑战性，因为FDA专员的再次称为[5]。为了接近这些更复杂的情景，各个案例可以细分为四个不同的类别：复杂的交付路由;复合配方;复杂的药物和复杂的药物 - 装置组合。

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