Intraperitoneal (IP) dose administration is the preferred method of dosing in the treatment of certain cancers as well as for peritonitis. Unfortunately, replicating IP administration in dogs in order to evaluate drug toxicity has posed multiple, serious challenges, rendering the approach unworkable in the laboratory. It is possible, however, to overcome these challenges by using a modified catheter with an access port to administer the investigational product. Frontage Labs has successfully applied this technique in dosing dogs as part of a study of a chemotherapy drug for ovarian cancer, demonstrating the viability of this method.
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Performing robust exploratory tests upfront can save time and money later on in the process. This infographic outlines the top reasons for why clients are encouraged to consider a comprehensive exploratory toxicology program and how it can provide success in GLP studies.
In this white paper, we show testing of two critical parameters for the method validation of Gyrolab: 1) carryover contamination and 2) after MRD (minimum required dilution) stability.
Gene therapy holds the promise to transform medicine and creates options for patients who are living with incurable diseases. The industry has been booming in the last 20 years. Before a gene therapy product can be used in humans, the product must be tested for safety and effectiveness. This webinar focuses on the introduction of three critical test methods: AUC, Infectivity and RCL assays. Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.