Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.

Background: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.

Methods: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence.

Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study.

Objectives: This study was conducted to assess the validity of recording (and the original diagnostic practice) of type 2 diabetes mellitus at a hospital whose records were integrated to a centralised database (the standardised common data model (CDM) of the Saudi National Pharmacoepidemiologic Database (NPED)).

Design: A retrospective single-centre validation study.

Settings: Data of the study participants were extracted from the CDM of the NPED (only records of one tertiary care hospital were integrated at the time of the study) between 1 January 2013 and 1 July 2018.