International Conference on Harmonisation ICH guidelines

Clearly, therefore, those involved in drug safety monitoring need to liase closely with both clinical research and medical information scientists. In addition, those responsible for clinical drug safety must undertake periodic safety update reports (PSURs) at predetermined intervals, in accordance with current International Conference on Harmonisation (ICH) guidelines. Such routine analyses can identify new safety signals as soon as they become detectable. 

International Conference on Harmonisation (ICH). Guideline for the Photostability Testing of New Drug Substance and Products. Federal Register 1997 62 27115-27122. 

Clcissical acute toxicity testing hcis been abolished due to International Conference on Harmonisation (ICH) guidelines. LDg values are no longer required worldwide and are therefore not allowed in the SPC. It is only applicable in exceptional cases to include information concerning clinical symptoms which appear in acute toxicity testing. 

All participants in a clinical trial must respect ethical and professional principles and guidelines such as the Helsinki Declaration and the International Conference on Harmonisation (ICH) guidelines for GCP. 

As required by regulatory authorities [1-3, 6] and International Conference on Harmonisation (ICH) guidelines [7], analytical method validation is especially important in establishing the assay methods and procedures of quantitative or semi-quantitative measurement of target substances or compounds. Among the specification items for drug products, assay, content uniformity, and dissolution are typical of those which require almost full analytical validation. The purity test, related... 

The report should comply with regulatory requirements as applicable, and be presented in a standard format. The report should cover at least the items listed in the International Conference on Harmonisation (ICH) guideline (8). 

International Conference on Harmonisation (ICH) Guidelines. Tripartite Harmonized Guidelines for Good Clinical Practice, Step 4. Geneva, ICH Secretariat (IFPMA), 1996. 

Occasionally drugs have a limited shelf life irrespective of the pack used, but at the other extreme, some drug formulations are inherently stable and therefore a pack is needed only to prevent direct contamination, i.e. dirt, dust, bacteria, etc. from the outside atmosphere, and for containment. However, few pharmaceutical products can exist without the supporting role of a pack, as many of the above product factors are not only interdependent with the pack, but ultimately represent a compromise between these and other conflicting needs. Traditionally pharmaceutical products have aimed for a 5 year shelf life where practical, or at least 3 years. General stability is currently supported through the International Conference on Harmonisation (ICH) guidelines. 

Delivering the right polymorphic form or solvate is crucial because these forms usually differ in their solubility and dissolution rate and because this area usually generates much regulatory scrutiny when a new drug application (NDA) is filed (International Conference on Harmonisation [ICH] Guideline Q6B, see Web site of ICH www.ich.org). 

There are several resources [1 - 6] available to aid the analytical scientist in performing method validation once a method has been developed. The International Conference on Harmonisation (ICH) guideline on Validation of Analytical Procedures Text and Methodology was recently updated to combine Q2A and Q2B in one document, Q2(R1) [1]. This guideline provides a defined approach to method validation and offers definitions on the validation elements and recommended data that should be included in the final report. 

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