Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

Production 52

Production Bioequivalency In-Vivo In-Vitro 52

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

Pharmaceutical Technology

JANUARY 6, 2023

It is important for a CDMO to understand the market it serves and, in the dermatologic arena, that means the demand for topical agents across a broad array of indications. In vitro release testing to demonstrate bioequivalence. Expertise in analytical testing, validation, and quality control are also essential.

Production 130

Production Manufacturing Development Bioequivalency 130