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Regulation, chiral drugs

Caldwell, J., (1995) Regulation of Chiral Drugs, Pharmaceutical News, 2, 22-23. Caldwell, J. (1995) Chiral Pharmacology and the Regulation of New Drugs, Chem. and Industry, 5, 176-179. [Pg.294]

A. C. Cartwright, "Stereochemistry and safety, efficacy and quality issues Genesis of new regulations," Drug Inform. J., 24 115-116 (1990). "Documentation for chiral drugs," Regulatory Affairs., 2-7 (Jan. 1991),... [Pg.410]

Branch, S. K., in International Regulation on Chiral Drugs, G. Subramanian (Ed.), Wiley-VCH,Weinheim 2001. [Pg.245]

Well aware of this fact and stimulated by the new policy statements issued by the regulating agencies [1-3], the pharmaceutical industry has, over the past decade or so, systematically begun to develop chiral drugs in enantiomerically enriched and possibly pure form. Currently [3], 68% of the 1200 drugs under development world-wide are chiral, and 75% of these (or an amazing 51% of the total number) are developed as single isomers. ... [Pg.98]

Branch, S. International regulation of chiral drugs. In Chiral Separation Techniques, A Practical Approach, 2nd Ed. Subramanian, G., Ed. Wiley-VCH Weinheim, 2001 319-342. [Pg.187]

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Chirality/Chiral drugs

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International Regulation of Chiral Drugs

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