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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports. Where Are the Technical Rejection Criteria for Study Data Applied? Validation Code.

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Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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ProstaStream

The Pharma Data

Because after many years of personal trials and experiments, I believe that I have finally discovered a special blend of ingredients which may help anyone support healthy prostate. The natural green tea contained by this formula, and the broccoli leaf extracts are also powerful ingredients. Thank you so much for watching and God bless!