The ritual of the Red Heifer is one of the most mysterious rituals in the entire Torah. (I have no doubt that this first sentence has been written many times before, but the ritual is so mysterious — ...
Pharmaceutical process chemists want to make the compound, the whole compound, and nothing but the compound. They know, however, that chemistry isn’t that simple and that a multistep synthesis often ...
What connection could there be between the commandment of the red heifer—one of the most mysterious commandments in the Torah, about which we read on Shabbat—and the moral and political challenges of ...
All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities. The safety of a drug product is as important as its effectiveness. Testing a drug for ...
To ensure patient safety, drug products must be tested for elemental impurities that pose risk. Potential elemental impurities in drug products have been analyzed for many years, with various methods ...
Though it’s hard to say exactly what the future holds for mass GLP-1 compounding, the pressure is mounting from multiple angles in the U.S. as drugmakers and the FDA alike seek to crack down on the ...
Since 2007, guidelines from the European Medicines Agency and a draft version from the U.S. Food & Drug Administration have called on the drug industry to reduce DNA-reactive genotoxic impurities ...