1. US FDA Guidance. Content and format of investigational new drug applications (INDs) for Phase 1 studies of Drugs, including well-characterized, therapeutic, biotechnology derived products. 1995.
2. US Code of Federal Regulations 21 CFR Part 312.23. IND content and format.
3. US FDA Guidance. Center for Biologics Evaluation and Research: use of pilot manufacturing facilities for the development and manufacture of biological products; guidance. 1995.
4. US FDA Guidance. Content and format of chemistry, manufacturing and controls information and establishment description information for a vaccine or related product. 1999.
5. World Health Organization. Guidelines for the production and quality control of synthetic peptide vaccines. WHO Technical Report series, No. 889. 1999.