Characterization of immune responses to polysaccharide and conjugate vaccines ... Characterization of innovative approaches to vaccine development, and evaluation ...
8/27/09. 1. What Is An IND? Loris McVittie, PhD. OVRR/CBER/FDA. 8/27/09. 2. Regulation. The regulations in 21 CFR 312 cover procedures and requirements for ...
Examples: sterility, adventitious agent tests. Generally, all released lots need to be tested ... sample is free of adventitious agents depends on the quantity ...
'The Researcher/Reviewer Model is essential to providing CBER with top-level ... Milan Blake, Ph.D.-Acting Director. Jay Slater, M.D.- Acting Deputy Director ...
Division of Hematology Emergency Preparedness Action Initiatives. Prepared by ... Facilitate accessibility of supplies for civilians. Discussions with CDC, DoD and NIH ...
Manufacturing (CGMP) in Investigational Products NIAID/ NIH April 15, 2005 Chris Joneckis, Ph.D. Senior Advisor For CMC Issues Center For Biologics Evaluation And ...
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed ... that the different age groups respond to the vaccine in equivalent manners? ...
Current State of Efficacy Evaluation of Pandemic Influenza Vaccines ... Therefore, evaluation of pandemic influenza vaccines is relying on immunological ...
LABOUR MOBILITY IN THE CARICOM SINGLE MARKET & ECONOMY (CSME) Steven Mac Andrew. Specialist, Movement ... Suriname 28. Related issues : Spouses and dependants; ...
Clinical endpoint ... Guidance for Industry Providing Clinical Evidence of Effectiveness for Human ... effect of change(s) on product's clinical performance ...
Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Inactivated Influenza Vaccines: Introduction Philip R. Krause, M.D. Outline Definitions and brief ...
This delays the availability of better, safer medical products for protecting ... Unique Role vis- -vis the Science of Biological Product Evaluation ...
All require production from live organisms (virus, bacteria, mammalian cells) ... and clinical safety, efficacy, concomitant use, consistency, bridging...
Design of Trials for Licensure of New Adult Pneumococcal Vaccine Indications ... Effectiveness Trials ... data can be obtained in efficacy/effectiveness trials ...
Viral pathogenesis. Vaccine safety and efficacy (including cell substrates) ... Viral Pathogenesis and Vaccine Adverse Reactions Team. Major Regulatory ...
The current situation with Influenza A/H5N1 highlights the need for ... 'Swine Flu Vaccine' experience in 1976. GBS 1 case per 100,000 persons vaccinated ...
99.9% had documented 5 previous doses of dip, tet and pertussis-containing vaccine ... Dip and tet 2-sided 95% CI of difference in seroprotection rates and booster ...
Development of transgenic mouse models to study pathogenesis and evaluate candidate vaccines ... Floor opened to discussion. Brief summary of discussion ...
... activity of cell substrate DNA with the aggressiveness of ... Evaluate any spontaneous tumors that develop for evidence of DNA from the cell substrate ...
Adult, rhesus macaque from which SFV has been well-characterized (biologically and molecularly) ... Juvenile, rhesus macaques will be obtained from a known ' ...