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An Interview with Dr. Piet Christians – American Pharmaceutical Review

Published In: American Pharmaceutical Review

Observed trends in regulatory expectations for the qualification of pharmaceutical container/closure systems from an extractables and leachables perspective

Question: A first observation you bring to the table is that – from a regulatory perspective – there is still a strong bias towards concerns about the quantitative aspect of E&L studies. Can you elaborate a bit more on this?

When assessing the impact of extractables or leachables from a safety perspective, there are two important pieces of information that will allow completing an in-depth toxicological assessment: the compound’s identity and its concentration or does to the patient.

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Piet Christiaens, PhD

Piet Christiaens, PhD

Scientific Director, E&L Expert

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers. Since 2001, Piet...