Pharmaceutical companies in the US are requesting additional information on how to conduct stability testing for both new and existing drugs in response to the International Council for ...
PITTSBURGH — The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...
Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...
ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...
ISO 17025-accredited California lab offers HPLC, LC-MS/MS, ICP-MS, and ICH stability studies with 48-hour turnaround for FDA submissions. IRVINE, CA, UNITED STATES ...