Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high.

Production 133

Production Bioavailability In-Vivo Bioequivalency 133

Camargo

JULY 8, 2021

At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe.

Development 130

Development Bioequivalency Gene Expression Drugs 130

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). This guidance was finalized in 2020.

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

Clinical Trials 59

Clinical Trials Clinical Trials Development Drugs 59

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

Development 246

Development Drugs Bioavailability In-Vivo 246