In this podcast, we discuss delivery modalities for sterile product development of poorly water-soluble drugs, with our special guest: Dr. Manish Mujal, Director of Product Development and CTM Manufacturing at Frontage Laboratories, Inc.
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Nanoemulsion has the potential to overcome several disadvantages in drug formulation. Nanoemulsions are nano-sized emulsions that can improve the bioavailability of drug molecules via various routes of administration. The development of nanoemulsion formulation is a challenging and lengthy process. Selecting components such as oil phase, surfactant, an optimum oil-to-surfactant ratio, and ideal process parameters are critical for developing a stable nanoemulsion. Development becomes more complicated when a drug molecule is sensitive to a variety of factors. This webinar discusses, with a case study, a nanoemulsion development process using a microfluidizer, and factors to consider while developing a sterile ophthalmic nanoemulsion formulation for a light, oxidation, and heat-sensitive molecule.
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 Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.
This webinar will provide a general overview of the regulatory guidelines required for developmental and reproductive toxicity (DART) testing. In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical DART studies using mammalian research models. These regulated studies provide important information regarding the effects of drug exposures prior to and during parental mating, as well as evaluating maternal and fetal changes during gestation, and identifying any alterations in the development of the offspring following birth.