Tag Archives: shelf life

  • Venturing into the Bold World of Combination Products

    … biocompatibility studies, bioavailability, pharmacokinetics and pharmacodynamics studies, analytical method development and validation, drug product specifications development, initial pharmaceutical shelf life (stability) study, clinical evaluation, annual stability commitment, routine lot testing and retain samples storage.  Such a list does not even consider other items a regulatory agency might request after reviewing the PMA or 510(k) submission documents.  Welcome to the bold world of …

  • BARDA and their Countermeasures Initiative

    … be a number of significant challenges to be addressed including: long term stability/shelf life of countermeasures, platforms for warm based production, platforms for surge production capability and technology solutions to promote efficient product transfer from clinical production to commercial scale manufacturing. BARDA’s strategy to achieve this will most likely involve a number of public private partnerships and considerable funding investment to support the relevant activities …

  • And the H1N1 Vaccine’s Surprises Keep Rolling

    … decreased. Baylor accepted that this pattern is not normal, having two withdrawals of a seasonal flu vaccine in the same season; however he explained that these are biologicals created from living organisms and thus, it is normal for the vaccine to lose effectiveness over time. It is for this reason that the vaccine has an authorized shelf life of 18 weeks and that the FDA demands that companies measure its effectiveness regularly.  MedImmune tests its products on a weekly basis, and it was on …