Jenke Dennis
Technology Resources Division, Baxter Healthcare Corporation, 25212 W. Illinois Route 120, Round Lake, IL 60073.
PDA J Pharm Sci Technol. 2012 Mar-Apr;66(2):168-83. doi: 10.5731/pdajpst.2012.00855.
During the course of their manufacturing, storage, and administration, pharmaceutical drug products come in contact with materials, components, and systems. Such contact may result in an interaction between the drug product and these entities. One such interaction is the migration of substances from these entities and into the drug product, which is of concern due to the potential toxicity of the migrating substances. In order to properly assess the risk and manage the hazard posed by migratory substances, it is necessary to establish the identities of the migratory substances and the levels to which they will accumulate in the finished drug product, as these two pieces of information establish the hazard posed by an individual substance and the magnitude of the patient exposure (dose). The process by which migrating compounds are discovered and identified, and by which their accumulation levels in a finished drug product are established, is termed chemical assessment. Because the development of a finished drug product is a long and complicated process, chemical assessment is most typically not a single action but rather a series of actions that together establish a process of risk management. It is the purpose of this manuscript to establish a high-level strategy, illustrated in the chemical assessment triad, which can be applied to such a risk management process.
During the course of their manufacturing, storage, and administration, pharmaceutical drug products come in contact with materials, components, and systems. Such contact may result in an interaction between the drug product and these entities. One such interaction is the migration of substances from these entities and into the drug product, which is of concern due to the potential toxicity of the migrating substances. It is the purpose of this manuscript to outline a high-level strategy, illustrated in the chemical assessment triad, to chemically establish the safety risk related to the migrating substances.
在药品的生产、储存和给药过程中，药品会与材料、组件和系统接触。这种接触可能导致药品与这些实体之间发生相互作用。其中一种相互作用是物质从这些实体迁移到药品中，由于迁移物质的潜在毒性，这一点令人担忧。为了正确评估风险并管理迁移物质带来的危害，有必要确定迁移物质的身份以及它们在成品药品中的累积水平，因为这两条信息确定了单个物质带来的危害以及患者接触的程度（剂量）。发现和识别迁移化合物以及确定它们在成品药品中的累积水平的过程称为化学评估。由于成品药品的开发是一个漫长而复杂的过程，化学评估通常不是单一行动，而是一系列共同建立风险管理过程的行动。本手稿的目的是建立一种高级策略，如化学评估三元组所示，可应用于这样的风险管理过程。
在药品的生产、储存和给药过程中，药品会与材料、组件和系统接触。这种接触可能导致药品与这些实体之间发生相互作用。其中一种相互作用是物质从这些实体迁移到药品中，由于迁移物质的潜在毒性，这一点令人担忧。本手稿的目的是概述一种高级策略，如化学评估三元组所示，以化学方式确定与迁移物质相关的安全风险。
