The release of acetyl salicylic acid from directly compressed alginate tablets was investigated.
The effect of the amount and type of alginate on the drug release rate was evaluated in …

This paper assesses the current regulatory environment, relevant regulations and guidelines,
and their impact on continuous manufacturing. It summarizes current regulatory …

Abstract Model-informed drug development (MIDD) approaches receive wide regulatory
acceptance in the European Medicines Agency (EMA) to support new drug development. For …

Background Internal radiotherapy requires the localization of the radionuclide to the site of
action. A new injectable alginate gel formulation intended to undergo immediate gelation in …

This paper summarizes the discussions and insights gained from the key themes that emerged
during the Quality by Design (QbD) Workshop held at the European Medicines Agency (…

In a continuous manufacturing process, input raw materials or mixtures are fed into a
process train continuously while the processed output materials are removed continuously. …

In their article ‘‘Statistical Properties of Large Sample Tests for Dose Content Uniformity,’’Shen
et al1 claim that the 2 options of the new European Pharmacopeia (Ph Eur 7.7) chapter ‘‘…