Regulations on chirality

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

Due to the direct effects of chirality on human health, an awareness of chirality is growing worldwide. Landoni et al. [11] reviewed the regulations on chirality in various other countries. The authors reported that Australia and Canada are also formulating regulations on chirality in dmgs, and that some Nordic countries are also moving in this direction. The authors also predicted that harmonization will take place on this issue in the world in... 

In 1993 Witte et al. [28] and in 1994 Rauws and Groen [29] reviewed the status of the regulation of chiral medicinal products on the pharmaceutical industries in the United States, Japan, and some European countries where designated authorities are responsible for the control and approval of newly developed drugs (both chiral and nonchiral). In the United States, new drug applications are submitted to the Food and Drug Administration (FDA), which requires appro-... 

The registration and approval situation in Japan is different from that of the USA and the European countries. In Japan, no official statements have been issued on the regulation of chiral dmgs [12, 19]. However, the Japanese registration authorities recommend adherence to the guidelines adopted in other countries. The Japanese authorities also recommend investigations into the absorption, distribution, metabolism and excretion of each of the enantiomers of a particular dmg. 

Langanke J, Leitner W (2008) Regulated Systems for Catalyst Immobilisation Based on Supercritical Carbon Dioxide. 23 91-108 Larock R (2005) Palladium-Catalyzed Annulation of Alkynes. 14 147-182 Larrow JF, Jacobsen EN (2004) Asymmetric Processes Catalyzed by Chiral (Salen)Metal Complexes 6 123-152... 

Sivolob, A., De Lucia, F., Alilat, M., and Prunell, A. (2000) Nucleosome dynamics. VI. Histone tail regulation of tetrasome chiral transition. A relaxation study of tetrasomes on DNA minicircles. J. Mol. Biol. 295, 55-69. 

Neurokinins comprise a group of peptides involved in nerve transmission. Specific members of this class of mediators control such diverse functions as visceral regulation and CNS function. The nonpeptide neurokinin antagonist talnetant (32-6), for example, has been evaluated for its effect on irritable bowel syndrome and urinary incontinence as well as depression and schizophrenia [36]. The quinoline portion of this compound is prepared by base-catalyzed Pfitzinger condensation of isatin (32-1) with the methoxy acetophenone (32-2). The methoxy ether in the product (32-3) is next cleaved by means of hydrogen bromide (32-4). Amide formation with the chiral a-phenylpropylamine (32-5) affords the neurokinin antagonist talnetant (32-6) [37]. 

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