- Metabolic Stability
- CYP Interaction
- Permeability & Transporters
- Physicochemical Properties
- Protein Binding
Discovery PK and Toxicology
EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine. It is a numbing cream that can be placed on skin to provide pain relief. It is often used to numb an area before placing an IV, drawing blood, or giving injections.
Typical stability study is conducted by the assay of active pharmaceutical ingredient (API) in the drug product. However, the assay results may not indicate drug product’s penetration rate similarity between different products over a certain period of time frame because of the differences in its topical product qualities (such as rheology, particle size, excipients, penetration enhancers, etc.). Therefore, it is important to evaluate the penetration of compounds into human skin during drug product stability study.
In vitro human cadaver skin model using Franz diffusion cells (invented in 1975) is widely regarded as the most valid in vitro model for evaluating the penetration of compounds into human skin. It can be used to determine the product equivalence.
Liquid biopsy is a sampling method for biomarker analysis that minimizes invasiveness, allows routine sampling, and is associated with circulating cell-free DNA. In this webinar, we talk about the benefits and challenges of sequencing cell-free DNA.
As biotech and pharma companies have become more streamlined and “virtual”, the use of CROs to conduct and/or manage portions of, or all of, a complete IND-enabling program has become common practice. However, the complexity of such programs, involving expertise in drug synthesis, regulatory, CMC, bioanalysis, toxicology, chemistry, pathology, and related disciplines makes management of these many inputs very challenging and subject to risks of poor execution or delayed submissions. This webinar, presented by a CRO-industry veteran, will provide insights on best practices, highlight common pitfalls, and identify “trade secrets” that can benefit industry newcomers, as well as more seasoned professionals. Topics addressed in this webinar include CRO qualification/selection, contracts, scheduling, protocol/program design, study conduct and monitoring, data and report review, and more. The session is intended to help participants interact more effectively and constructively with their CRO partners and ultimately save time, money & headaches in their development programs.
Speaker: Glenn Washer, President, Frontage Laboratories North America and Executive Vice President for Global Safety and Toxicology, Frontage Laboratories, Inc.
Glenn is a board-certified toxicologist, with >35 years in the industry. Prior to Frontage, he headed Charles River’s North America preclinical businesses and earlier served in executive roles in international CROs & Biotechs. He served as Faculty for the Pharmaceutical Education & Research Institute, as an Editorial-board-member of the International Journal of Toxicology, and lecturer for the Society of Toxicology, Drug Information Association, Society of Quality Assurance, McGill University and Universite de Montreal. He has also served on multiple corporate and industry boards.