Development and registration of chiral drugs.
In this review we describe the impact of chirality on drug development and registration in the United States, Japan and the European Community. Enantiomers may have differences in their pharmacological profiles, and, therefore, chiral drugs ask for special analytical and pharmacological attention during their development. However, the registration authorities have no clear policy towards the registration of chiral drugs. The absence of a clear policy regarding chirality causes a great deal of confusion and frustration at various levels and is not in the interest of industries developing newer and more beneficial drugs.
Witte
D T
DT
Department of Analytical Chemistry and Toxicology, University Centre for Pharmacy, Groningen, The Netherlands.
Ensing
K
K
Franke
J P
JP
De Zeeuw
R A
RA
D005062:European Union; D007564:Japan; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013237:Stereoisomerism; D014481:United States
D004364:Pharmaceutical Preparations