By Joseph T. Piechocki, Karl Thoma

ISBN-10: 0824759249

ISBN-13: 9780824759247

In keeping with a coaching direction built via Dr. Joseph T. Piechocki and different specialists during this box whose contributions seem during this ebook for 2 overseas conferences at the Photostability of gear and Drug items, this article clarifies the information set via the overseas convention on Harmonization (ICH) and offers a finished historical past within the medical rules concerned about photostability testing.  offering the benefits and downsides of assorted methods so the reader can decide upon and make the most of the main applicable method best-suited to their wishes, this resource contains references to present literature within the box and gives an opinion on destiny possibilities and demanding situations.

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25. selected were frequently cited in the literature as to their light sensitivity, a fact not necessarily always borne out by subsequent testing. The degree of deterioration of the chemicals studied was determined using the official assay whenever possible. In other instances, assays for specific impurities or color changes were used. D. dissertation (25). Results obtained on some of these same chemicals are reported in Table IV of their report as to their “General Findings as to Deterioration” (24).

INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINE DEVELOPMENT ICH Steering Committee was established and had its first meeting in April 1989. The main purpose of this organization was “…to seek ways to eliminate redundant and duplicative technical requirements for the registering new medicinal substances and products. ” ICH 1, the first international ICH meeting, was held in Brussels in November of 1991. This meeting, sponsored by the Commission of the European Communities and the European Federation of Pharmaceutical Industries’ Associations (EFPIA), was composed of three parallel workshops on the topics of Quality, Safety, and Efficacy and identified 11 topics for harmonization.

The main purpose of this organization was “…to seek ways to eliminate redundant and duplicative technical requirements for the registering new medicinal substances and products. ” ICH 1, the first international ICH meeting, was held in Brussels in November of 1991. This meeting, sponsored by the Commission of the European Communities and the European Federation of Pharmaceutical Industries’ Associations (EFPIA), was composed of three parallel workshops on the topics of Quality, Safety, and Efficacy and identified 11 topics for harmonization.

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Pharmaceutical photostability and stabilization technology by Joseph T. Piechocki, Karl Thoma


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