Pharmaceutical Technology

OCTOBER 28, 2022

They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

Worldwide Clinical Trials

MAY 30, 2024

Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

Pharmaceutical Technology

FEBRUARY 23, 2023

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products.

Development 246

Development Drugs Bioavailability In-Vivo 246