Takeda Pharmaceuticals, Cambridge, MA, USA.
Inotiv, Maryland Heights, MO, USA.
Toxicol Pathol. 2022 Feb;50(2):252-265. doi: 10.1177/01926233211049156. Epub 2021 Oct 26.
Samples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies. Good Laboratory Practice regulations and/or guidance specify minimum requirements for specimen retention duration, with the caveat that retention of biologic specimens need not extend beyond the duration of sample stability. However, limited availability of published data regarding stability for various purposes following storage of each specimen type has resulted in confusion, uncertainty, and inconsistency as to the appropriate duration for storage of these specimens. To address these issues, a working group of the Society of Toxicologic Pathology Scientific and Regulatory Policy Committee was formed to review published information, regulations, and guidance pertinent to this topic and to summarize the current practices and rationales for retention duration through a survey-based approach. Information regarding experiences reaccessing biologic specimens and performing sample stability investigations was also collected. Based on this combined information, the working group developed several points to consider that may be referenced when developing or revising sample retention practices. [Box: see text].
在非临床毒性研究过程中，通常会常规收集生物标本及其衍生物（例如湿组织、石蜡包埋组织块、组织学载玻片、冷冻组织、全血、血清/血浆和尿液）。良好实验室规范法规和/或指南规定了标本保留期限的最低要求，但需注意，生物标本的保留期限不必超过样品稳定性的期限。然而，由于缺乏关于各种目的的稳定性的已发表数据，在存储每种标本类型后，对于这些标本的适当存储期限存在混淆、不确定性和不一致性。为了解决这些问题，毒理学病理学科学和监管政策委员会的一个工作组成立，以审查与该主题相关的已发表信息、法规和指南，并通过基于调查的方法总结当前保留期限的实践和理由。还收集了有关重新访问生物标本和进行样品稳定性研究的经验的信息。基于这些综合信息，工作组制定了一些需要考虑的要点，在制定或修订样品保留实践时可以参考这些要点。[框：见正文]。
