ICH guidelines on

Guidance on specifications is divided into universal tests/criteria which are considered generally applicable to all new substances/products and specific tests/criteria which may need to be addressed on a case-by-case basis when they have an impact on the quality for batch control. Tests are expected to follow the ICH guideline on analytical validation (Section 13.5.4). Identification of the drug substance is included in the universal category, and such a test must be able discriminate between compounds of closely related structure which are likely to be present. It is acknowledged here that optically active substances may need specific identification testing or performance of a chiral assay in addition to this requirement. 

Where toxic gases or solvents have been used in the manufacturing process, validation data on their removal and relevant release and shelf life specifications and acceptance limits should be included in the dossier (taking into account the ICH guidelines on residual solvents and the CPMP guideline on ethylene oxide usage). These can be discussed in the development pharmaceutics section or elsewhere. 

The duration of repeat-dose studies for both clinical trials and marketing applications are given in Tables 3.1 and 3.2, which are taken from the ICH guideline on the timing of Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, as amended in November 2000. 

ICH guidelines on pharmacovigilance have been further developed. 

International Conference on Harmonisation of technical requirements for the registration of Pharmaceuticals for Human use. ICH guidelines on Male Fertility Studies S5 (R2) November 2005... 

Structural information of stress-induced degradation products can also be used to assess the potential for formation of toxic degradation products. Both ICH guidelines on impurities (drug substance and drug product) specifically address the issue of potential toxic impurities ... 

Mineshima H, Endo Y, Ogasawara H, et al. Impact of globalization under the ICH guidelines on the conduct of reproductive toxicity studies—report on current status in Japan, Europe and the US by questionnaire survey. J Toxicol Sci 2004 29(3) 201-15. 

Jena GB, Kaul CL, Ramarao P. Regulatory requirements and ICH guidelines on carcinogenicity testing of pharmaceuticals a review on current status. Ind J Pharmacol 2005 37 209-22. 

ICH Guideline on Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (S7B). Sept, 2, 2003... 

According to the ICH guideline on stability testing, the purpose of stress testing is twofold [45]. First, it can be used to predict the stability of the molecule and from the degradation products establish degradation pathways. Second, it can validate the stability-indicating capability of the analytical... 

---