Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US.

ABSTRACT:

Importance

Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals.

Objective

To determine whether there were clear and substantive differences in major quality attributes between difficult-to-make solid oral dosage form pharmaceutical products marketed in the US.

Design, setting, and participants

This quality improvement study analyzed US Food and Drug Administration-collected samples of 252 drug products marketed in the US and manufactured in the US, Canada, Europe, India, and the rest of Asia. These drug products were immediate-release solid oral dosage forms considered difficult to make on the basis of product quality history. This sampling included 35 innovator and 217 generic drug sa

SUBMITTER: Fisher AC 

PROVIDER: S-EPMC7445591 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature