International Conference Harmonisation guidelines

Robustness of a method is defined as a measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage [International Conference Harmonisation (ICH) Guideline Q2A (2)]. Intervals for method... 

The use of DOE in the pharmaceutical industry began early. For example, S. M. Free, while head of statistics at Smith Kline French in 1957, wrote an internal statistics booklet with F. A. Oyer (14). It showed how DOE could be used in formulation development and stability studies. Now called matrixing, this approach is now referenced in International Conference Harmonisation (ICH) Guideline Q1 (15). Many articles on DOE have appeared in the pharmaceutical literature during the past 25 years (16-31). Currently, the routine use of DOE is sporadic. The key to its success is an... 

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... 

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... 

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

ICH (2005) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Impurities Guideline for... 

International Conference on Harmonisation, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures Methodology, November 1996. 

Guidelines prepared within the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), Validation of Analytical Procedures, Q2A Definitions and Terminology, 1995, pp. 1-5, http //www.ich.org/... 

Quantitative CE—MS studies were scarcely reported. " This subject is however of prime importance, particularly for the pharmaceutical industry where the reliability of analytical data is essential. For this reason, method development is generally followed by an evaluation of quantitative performance using an appropriate validation procedure performed in agreement with criteria established by the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) and the Food and Drug Administraction (FDA) guidelines, or Societe Franqaise des Sciences et Techniques Pharmaceutiques (SFSTP) commissions. ... 

A.C. Moffat, A.D. Trafford, R.D. fee and P. Graham, Meeting of the International Conference on Harmonisation s guidelines on vahdation of analytical procednres Qnantiflcation as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets. Analyst, 125, 1341-1351 (2000). 

International Conference on Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use. Topic E6 Note for Guidance on Good Clinical Practice Consolidated Guideline, CPMPIICHI135I95. London European Agency for the Evaluation of Medicinal Products, 1996. 

Food Drug Administration (PDA). International conference on harmonisation, good clinical practice consolidated guidelines. Federal Register 1997 62 25692-709. 

International Conference of Harmonisation. E6 Guideline for Good Clinical Practice, 1996. http //www.emea.eu.int/pdfs/human/ich/ 013595en.pdf, Accessed January 2005. 

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. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

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... 

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (2005) ICH harmonised tripartite guideline. Detection of toxicity to reproduction for medicinal products 8c toxicity to male fertility, S5(r2) current step 4 version parent guideline dated 24 June 1993 (addendum dated 9 November 2000 incorporated in November 2005)... 

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