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Clinical Research Solutions
We saw in Part 1 of this series how a confidence interval can be calculated to define a range within which the true value of a statistical parameter such as a mean or standard deviation is likely to...
Clinical Research Solutions
In a Federal Register notice published today, the Food and Drug Administration (FDA) announced its intention to take enforcement action against misbranded or unapproved prescription products...
Clinical Research Solutions
If enforcement against pharmaceutical companies for off-label promotion by the Office of Inspector General (OIG) and the Department of Justice (DOJ) and the Food & Drug Administration (FDA) were not...
Clinical Research Solutions
The Food and Drug Administration (FDA) recently published a draft guidance that outlines the “Naming of Drug Products Containing Salt Drug Substances” in accordance with the recently implemented USP...
Quality & Compliance
If you have been following along, you now know that I have reviewed the first three gates to the Nine Gate Transfer Process for moving production from site to site. I have covered: Gate 1: Assessment...
Clinical Research Solutions
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...
Clinical Research Solutions
The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...
Clinical Research Solutions
In a Federal Register notice to be published on Dec. 10, 2013, FDA announced the release of a new guidance titled “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules.” The...
Quality & Compliance
Today I would like to present the third entry in the series discussing the Nine Gate Transfer Process for moving production from site to site: the Gate 3 Transfer Plan. In case you missed them, you...