Survey Result for E-labeling Initiatives in Asia.

Under the COVID-19 pandemic, various electronic labeling initiatives have accelerated worldwide in the healthcare and pharmaceutical fields as part of a wider digital transformation [1, 2]. Although there is no universal definition of electronic labeling (e-labeling) globally, it is widely understood that e-labeling refers to the product information that is distributed via electronic means. There are 5 factors to be considered in e-labeling, and these are discussed in this publication.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.

Literature data and results of experimental studies relevant to the decision to allow waiver of bioequivalence studies in humans for the approval of immediate release solid oral dosage forms containing cephalexin monohydrate are presented. Solubility studies were performed in accordance with the current biowaiver guidelines of the Food and Drug Administration, World Health Organization and European Medicines Agency, taking the degradation at some pH values into consideration. Together with solubility and permeability data for cephalexin monohydrate from the literature, it was demonstrated to be a Biopharmaceutics Classification System Class 1 drug.