The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

The guideline updates the last AHA/ASA ICH guideline published in 2010 and incorporates the results of new studies published in the interim. The guideline update was purposely delayed for 1 year ...

Noting that "current guidelines equivocate about the use of antithrombotic and statin medications after ICH because of the perceived risk of recurrent ICH," Simonetto and Murthy say the present ...

The Revised ICH E8: A Guide to New Clinical Trial Requirements management report shows readers how to leverage the revised guidelines' quality-by-design approaches, expanded study designs and data ...

The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.

This Q11 guideline describes approaches to developing process and drug substance understanding. It also offers guidance on information that should be included in related common technical documents.

The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic ...

Advaned kinetic modeling can serve as a powerful tool to reduce development risks for any type of biopharmaceutical.