While the biologic drug market has shown significant growth over the last decade, oral solid dose forms (OSD) remain the most commonly used method of…
Category: Pharmaceutical
Overview Using the principles outlined in ICH Q3D and training modules we will: • Present a series of risk assessments based on actual products. •…
As 2018 drew to a close, we had a look at how many companies had been doing and what their prospects were for the new…
Scaling up is a problem a lot of biotechs find difficult, both in terms of developing from a small startup to a larger company and…
The biohacking movement is making scientific research accessible to everyone under the form of low-cost community labs. What does it mean to be a biohacker…
Automation is slowly taking over our lives, ranging from smart homes to self-driving cars. With experiments becoming ever more complex and datasets more immense, a…
The United States Pharmocopeia (USP) and the International Conference on Harmonisation (ICH) both specify limits for elemental impurities in drug products. The USP specifications are…
Purpose: To provide answers to questions that have been frequently asked of members of the ICH Q3D Expert Working Group. General FAQs 1. Why is…
TosupportthepracticalimplementationoftheInternationalCouncilforHarmonisation(ICH)Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceutical companies has established a database to collate…
Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present…