Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device. Orally inhaled and nasal drug product (OINDP) formulations, which are primarily a ...
Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards. Speaking ...
Dr Bettine Boltres, Product Manager, Pharmaceutical Tubing, SCHOTT, Germany in this white paper, touches on a risk-based approach of the evaluation and describes important facts to consider when ...
The addition of USP 1663 and USP 1664 extractable and leachable testing services is a natural progression to the current USP container and package system qualification work that the CS Team currently ...
Polymer sheets of PDMS, PC, and TPU were prepared for each polymer with a thickness of no less than 0.5 mm, and these sheets were then cut into approximately 8 cm × 8 cm pieces. Several pieces of each ...
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