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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 12 September 2002. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. link] 10 a b c US Food and Drug Administration. “A link] 11 Beierle, J., Cauchon, T.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 12 September 2002. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. link] 10 a b c US Food and Drug Administration. “A link] 11 Beierle, J., Cauchon, T.

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Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

This big news was newly emerging research in 2002 when I started pharmacy school, 20 years after their initial discovery. Thymoquinone (TQ), one of the active compounds found in black seed oil, acts as a biofilm disruptor, meaning that it can break free from the protective coating that H. Eventually, the rest of the world caught up.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Published 2002. Burke, PhD.