Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

pharmaphorum

JANUARY 17, 2022

The man who sent the price of lifesaving drug Daraprim (pyrimethamine) rocketing from $13.50 Until recently, Daraprim was the only drug available to treat the disease and has been the gold standard treatment for toxoplasmosis for decades. a tablet to $750 overnight has been ordered to repay $64.6m (£47m).

Bioequivalency 45

Bioequivalency Generic Drugs Contamination Drugs 45

Pharmaceutical Technology

JANUARY 6, 2023

In vitro release testing to demonstrate bioequivalence. Products must also be tested for bioburden to demonstrate that they do not harbour microbial contaminants. Even the smallest details can have a big impact on the end result, especially when it comes to the sensory characteristics and the bioequivalence of a topical product.

Production 130

Production Manufacturing Development Bioequivalency 130