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

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. Approaches to Pharmacokinetic Analysis.

Production 133

Production Bioavailability In-Vivo Bioequivalency 133

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

In vitro release testing to demonstrate bioequivalence. It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Simplicity matters.

Production 130

Production Manufacturing Development Bioequivalency 130