Safety Testing of Dengue-1 and Dengue-3 Seeds for Human Challenges, Unattenuated.
Abstract
Dengue Virus Type 1 (non-attenuated) Strain: Western Pacific 1974, LOT No. 1 of February 1984 was satisfactorily safely-tested in accordance with the guidelines established by the FDA for live and inactivated vaccines as stipulated in 21 CFR, Parts 610.11, 610.12, 610.30, 630.10-630-18, etc. All testing procedures were carried out following Good Laboratory Practices regulations (21 CFR, Part 58). Keywords: Laboratory tests; Prevention; Virus diseases.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 01, 1986
- Accession Number
- ADA177494
Entities
People
- Louis Potash