Stability Testing of Clinical Samples

Abstract

The stability program for clinical samples as presented is based on the ICH Tripartite Guideline for Stability Testing of New Drug Substances and Products and the same principles that the program followed throughout the development of a drug product. But the Guideline and the basic principles were adapted to deal with the specific problems encountered with clinical samples. The expiration dates represent minimum shelf lives, storage conditions, and storage periods, and the minimum shelf lives correspond the duration of the clinical trials in phases I to III. Shelf lives are established on the basis of stress and accelerated tests to provide all batches with an open expiration date. They are supported and confirmed by long-term tests conducted under the storage conditions presenting climate zone II, 25°C/60% RH. The self lives determined apply to all the batches of the relevant development stage, although only the batches in the final phase of development originate from a validated manufacturing phase. For different dosages, dosage forms, and packaging materials, the number of batches and analysis is reduced by scientifically based rationalization measures such as bracketing and matrixing. The stability results obtained with clinical samples are a major factor for achieving a comprehensive assessment of the quality of a finished medicinal product. In this way it is possible to establish a link between the quality of clinical batches for phases I-III and the quality of the finished drug product.