Roots Analysis

FEBRUARY 20, 2022

Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Our Social Media Platform. Web: [link]. LinkedIn: [link].

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

Camargo

AUGUST 22, 2021

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. 3.1.1: Bioavailability Study Reports. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.

Containment 190

Containment Bioavailability Cosmetics Packaging 190

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59