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

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 latest ICH guideline, Q14, complements Q2(R2) for the validation of analytical procedures. Revision of Q2(R1) into Q2(R2) aligns its implementation with Q14(1), ensuring coherence between both ...

The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.

Several "standard care" therapies for ICH are not as effective as once thought and are no longer recommended in updated guidelines.

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 ...

The E3 Guideline was released by ICH in November 1995 and describes how sponsors should compile and present single, integrated core clinical study reports (CSRs) acceptable to all the US Food and Drug ...

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.

Ready to visit the stunning island of Boracay? In this video, I’ll guide you through all the steps for getting to this tropical paradise, from flights to boat rides. Whether you’re traveling ...