Pharmaceutical Starting Materials: Safe Trade
High-quality starting materials for medicinal products are essential to the high quality of finished products. In 1995 and 1996 adulterated glycerin caused acute renal failure and subsequently death of about 88 children in Haiti. This case is discussed with respect to risk detection and analysis in...
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Veröffentlicht in: | Drug information journal 2001, Vol.35 (2), p.611-616 |
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Format: | Artikel |
Sprache: | eng |
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Online-Zugang: | Volltext |
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Zusammenfassung: | High-quality starting materials for medicinal products are essential to the high quality of finished products. In 1995 and 1996 adulterated glycerin caused acute renal failure and subsequently death of about 88 children in Haiti. This case is discussed with respect to risk detection and analysis in the manufacture, distribution, and trade of active as well as nonactive starting materials. Parties involved are not sufficiently aware of the risks. Overall, there is lack of transparency. There is strong need for a Good Trading Practice. Recommendations to health authorities conclude this brief overview. |
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ISSN: | 2168-4790 0092-8615 2168-4804 2164-9200 |
DOI: | 10.1177/009286150103500233 |