Stability studies to support

Stability studies to support a requested shelf life and storage condition must be run under real-time, real-temperature conditions [16,17], The prediction of shelf life by using stability studies obtained under stress conditions and Arrhenius plots is not meaningful unless it has been demonstrated that the chemical reaction accounting for the degradation process follows first-order reaction. 

The design of stability studies to support submission of NDAs and MAAs are described in the ICH Guidance QIA (R2) Stability Testing of new E>mg Substances and Products (3). The sections relevant to solid dosage forms are described below. 

Complete stability studies to support the approved shelf life. 

The information obtained from the stress studies and the phase I and II studies should be reflected in the protocol for the primary stability studies to support the final phase III clinical trials. 

Stability Studies to Support Production and Use of Pre-clinical and Clinical... 

Fig. 2.1 Stability studies to support development of new drug product...

A stability survey was done in 2007 by AAPS Stability Focus Group, benchmarking industry standards and practices of their stability operations within the pharmaceutical and biopharmaceutical industry. It noted that the majority of the industry has used ambient room temperature as the long-term storage condition to conduct stability studies to support clinical trial application. 

Chapter 2 introduces the critical current Good Manufacturing Practices (cGMP) regulations that are applicable to a stability program. It describes different types of stability studies to support the drug development process and discusses the GMP requirements surrounding the stability sciences. 

Extrapolation of the real-time data from the long-term stability study to support a retest period longer than that of the real-time data can be proposed. The proposal should be supported by accelerated data, knowledge of the degradation mechanism, additional supportive stability data from batches other than the primary registration batches that might be available, and the goodness of fit of the mathematical model used in the statistical analysis. 

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