1. Note for guidance on the pre-clinical safety testing of medicinal products derived from biotechnology;European Community,1988
2. The Japanese Perspective Regarding Regulatory Concerns for Biotechnology Drugs and Their Scientific Basis;Hayakawa,1991
3. 27th Annual Japan-US Business Conference: Bilateral forum on the harmonization of the scientific principles and procedures underlying the regulations related to biotechnology,1990
4. Critical Analysis of the Guidelines of the USA, EEC and Japan;Giss,1990