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Extractable and leachable evaluation is an integral part of safety assessment of container closure system, drug-device combinations, manufacturing equipment and accessories, and medical devices. The analytical methods employed in the analysis should be able to quantify toxicologically significant amount of E&L, which is driven by Analytical Evaluation Threshold (AET). This webinar focuses on the application of toxicological principles in defining AET and designing the E&L study. The E&L study may end up in large number of chemicals which requires to be evaluated to determine whether they pose any risk to patient health. We describe how application of science of toxicological risk assessment can make use of all available information for the identified E&L and negate the need for additional E&L studies, thus speeding up the product development and approval.
Dr. Sebastian is a Veterinarian and a Certified Toxicologist and currently working as Senior Director and Head of Toxicology. Dr. Sebastian has over 16 years of industrial experience that includes drug discovery, non-clinical development of drugs and vaccines, experimental toxicology and pharmacology, Good Laboratory Practices (GLP), computational toxicology, human health risk assessment, environmental risk assessment, and medical writing.
Dr. Sebastian is currently involved in strategic development and consulting services in pharmaceutical product development with special reference to non-clinical and toxicological requirements; non-clinical evaluation strategy in support of IND and NDA; risk assessment of pharmaceutical active ingredients and excipients; health based exposure limit (HBEL) derivation; impurity qualification of APIs and drug products; and environmental risk assessment of pharmaceuticals.
Dr. Sebastian has extensive experience in the risk assessment of extractable and leachable chemicals pertaining to pharmaceuticals and medical devices. Dr.Sebastian is a Diplomat of American Board of Toxicology and a European Registered Toxicologist.
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