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Bioavailability

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Nanoparticles: Emerging Stars for Pharmaceutical Industry

Roots Analysis

FEBRUARY 20, 2022

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.

Contract Manufacturing

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems

Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

FDA Law Blog

JANUARY 23, 2023

Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act). This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol.

Trials

Trials Clinical Trials Clinical Trials Drugs

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

Nanoparticles: Emerging Stars for Pharmaceutical Industry

Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

Webinars

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