ACT Webinar: Approach to Development of an Inhalation Excipient for Regulatory Approval: Case Studies with HFA-152a and DSPC

We were pleased to hear from our colleagues at the American College of Toxicology that they successfully hosted another Signature Webinar earlier this month.  The BTS sponsors these excellent webinars and the recording & materials are now available to BTS Members.

Jake McDonald, PhD, Lovelace Biomedical
Philip J. Kuehl, PhD, Lovelace Biomedical

The purpose of this webinar is to define the requirements for regulatory development of excipients used in respiratory formulations. As a part of the regulatory development pathway, pharmacology, toxicology, and clinical studies are conducted. These studies require specialized approaches to determination of maximum feasible dose, determination of drug absorption/pharmacokinetics, and design of the toxicology programs. This webinar will describe the approach for the technical and regulatory approval, utilizing two case studies that involve excipients of broad importance to respiratory therapy and represent pressurized meter dose inhalers [1,1-Difluoroethane (HFA-152a)] and dry powder excipients [phosphatidylcholine (PC), 1,2-distearoyl-sn-glycero-3-phosphocholin, DSPC)]. The regulatory discussion will consider both US and international requirements. The webinar included an overall approach and technical details that include system characterization (in vitro, rodent, canine, human), analytical and bioanalytical assessment, pharmacokinetics, and toxicology including dose range finding, safety pharmacology, carcinogenicity, IND, and NDA studies.

You can view this and other ACT webinars by visiting the our Member Resources Page (log in required).  Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the BTS members for educational purposes only. Any distribution or copy of the materials is prohibited.

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