International Committee Harmonization

In 1995, discussions among the United States, the European Community (EC), and Japan occurred to achieve harmonization of dmg and dmg product standards and to provide guidance to the worldwide pharmaceutical industry for acceptance of global regulatory filings. The International Committee on Harmonization (ICH) has proposed initial guidelines for the estabUshment of stabihty studies. 

The Aspen NRTL-SAC solvent database was identified from the list of solvents presented in the pharmaceutical based International Committee on Harmonization s guidelines for residual solvents in API [28], Hexane, Acetonitrile and Water were selected as the basis for the X, Y and Z segments respectively, the binary interaction parameters for the segments together with molecular descriptors in terms of X,Y and Z segments were then regressed from experimental vapour-liquid and liquid-liquid equilibrium data from the Dechema database. The list of solvent parameters that were used in the case study are given in Table 13. 

Review of compatibility data in this manner is important and useful in many cases. If Arrhenius treatment fits the decay observed in the compatibility samples, data obtained under relatively short-term accelerated stress conditions can efficiently be used to extrapolate the amount of decay expected at realistic long-term storage conditions. The adherence of decay to Arrhenius kinetics provides the formulator with a powerful tool for prediction and understanding of degradation. This decay model is the basis for the International Committee on Harmonization (ICH) quality guidelines... 

According to the International Committee on Harmonization and Good Clinical Practice guidelines (ICH/GCP), in the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic... 

Dr. Edwards chaired the PMA Special Population Committee, and also sat on the Institute of Medicine Committee for Research in Women, sponsored by the US National Instates of Health. He also served on the efficacy subcommittee Topic 5 (Acceptability of Foreign Clinical Data) for the International Committee on Harmonization (ICH). 

The repositories of the essential regulatory documents of the European Regulatory Agency (EMEA), the US Food and Drug Administration (EDA) and of the tripartite International Committee of Harmonization (Europe, USA and Japan) (ICH) organization can be found with the following links ... 

The opportunity to accomplish this task has been greatly enhanced with the introduction of guidelines and recommendations formulated by the International Committee of Harmonization (ICH). This committee estab-lished safety, efficacy, and quality guidelines for new drag development in order to expedite international registrations. These guidelines give a basis for uniformity of data, developed for pharmaceutical products, that will be used as evidence for product approvals. 

The nature and extent of work to be performed during development can be modeled after the draft International Committee on Harmonization (ICH) Q6A document on specifications, which can be found on the Food and Drug Administration (FDA) website (www.fda.cder.gov). This document outlines the specifications needed for a New Drug Application and contains several decision trees to guide the selection of specifications. The Q6A decision tree 4 (Fig. 2) describes... 

ICH International Committee on Harmonization of technical requirements of pharmaceuticals for human use ID 50 Dose causing 50% inhibition in the population studied IM Intramuscular IND Investigational new drug IP Intraperitoneal... 

The International Committee on Harmonization (ICH) Good Clinical Practice guidelines E6(R1), EDA Regulations relating to good clinical practice and clinical trials (CER 21), and EDA Good Laboratory Practice guidelines may be helpful references. New projects that use an established biorepository are submitted for determination of review status (e.g., exempt, expedited, full board review). 

International Committee on Harmonization (2005) Pharmaceutical development Q8. International Committee on Harmonization (2007) Pharmaceutical development annex to Q8. Atkins P (1996) Physical chemistry. 5th edn Freeman, p 543. 

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