Nelson Laboratories, LLC

In this webinar, the challenges in toxicological safety assessments for parenteral packaging system applications will be addressed.

Typical toxicological challenges for extractables and leachables are presented, such as difficulties in daily exposure evaluations for a selection of compounds to be evaluated, based on an appropriate selected threshold. Subsequently, typical burden in hazard and risk evaluation relate to data-poor substances often related to rubber closure systems. Within this context, E&L examples are selected for which the critical toxicological endpoints are discussed and evaluated by means of various methods, in terms of deriving appropriate safety limits.

Selecting the right Threshold for E&L screening methodologies

What will be reasonably exposed to the patient

Understanding the toxicological safety hurdles and how to overcome them

Will pro’s and con’s of surrogates be addressed for ADME And DMPK?

Analytical scientists, safety assessors, regulatory affairs

Kevin Breesch, MSc
Manager Toxicology
Nelson Labs

Wednesday, November 17, 2021 at 11am EST, 10am CST, 8am PST

On demand available after final airing until November 17, 2022.

Webcasts

**Wednesday, November 17, 2021 at 11am EST, 10am CST, 8am PST***  TE&L examples are presented for which the critical toxicological endpoints are discussed and evaluated by means of various methods, in terms of deriving appropriate safety limits. *** On demand available after final airing until November 17, 2022.***


Assessing the safety of extractables and leachables for drug products: when and how?

Articles

Extractables Study Design and Challenges: Packaging Systems for Parenteral Drugs

All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products go through especially rigorous testing to ensure sterility and safety.
