1 / 1

Laboratory and animal studies

FDA Role Throughout Pandemic Influenza Vaccine Development, Evaluation and Availability Activities Involving FDA Assistance, Research & Review. Pre-Post-IND. Pre-IND. Laboratory and animal studies. Development of manufacturing processes, pilot lots, assays. Development and

medge-mckee
Télécharger la présentation

Laboratory and animal studies

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. FDA Role Throughout Pandemic Influenza Vaccine Development, Evaluation and Availability Activities Involving FDA Assistance, Research & Review Pre-Post-IND Pre-IND Laboratory and animal studies Development of manufacturing processes, pilot lots, assays Development and selection of candidate vaccines and technologies Immunogen Identification (e.g. protein, strain) and proof of concept IND Phase 1 Human Studies Phase 3 100s – 1000s Licensing Phase 4 General Investigational Plan Phase 2 • Facility • Inspections • Safety • Efficacy • Lot release • Safety • Immunogenicity • Efficacy • Efficacy • Safety • Safety • Immunogenicity • (surrogate markers) • Dose Ranging Manufacturing & Facility Assessment Supplements (e.g. new facilities, population, strains) Possible EUA Pre EUA

More Related