Current regulatory (draft) guidance on chiral medicinal products: Canada, EEC, Japan, United States

• Published in: Chirality (New York, N.Y.) Vol. 6; no. 2; p. 72
• Main Authors: Rauws, A G, Groen, K
• Format: Journal Article
• Language: English
• Published: United States 1994
• Subjects: Animals; Canada; European Union; Guidelines as Topic; Humans; Japan; Legislation, Drug - trends; Stereoisomerism; United States; Canada; United States; Japan

The rapid development of stereospecific analytical, synthetic, and preparative methods has profoundly changed the prospects for development and application of chiral medicinal products. This has induced regulatory agencies, e.g., in Canada, the EEC, Japan, and the United States, to prepare guidance...