Alinea 124 Gerechtshof 's-Gravenhage 24 januari 2012

In het artikel van De Camp is vermeld (blz. 5, rechterkolom, blz. 6 linkerkolom): 'A thorough understanding of the pharmacokinetics of any drug is essential for the determination of a safe and effective dosage regime. In the case of a racemic drug, therefore, this implies knowledge of the in vivo behaviour of the pure stereoisomers. (...). The use of combinations of drugs to improve therapeutic efficacy is not unusual. FDA's regulations require that, in such a combination, 'each component makes a contribution to the claimed effects and (...) that the combination is safe and effective.' The potential for application of such a regulation to racemates seems obvious, though not explicitly stated in the CFR. Our Guideline notes, 'even in racemates...enantiomers may be considered as impurities.' A formal extension of the combination drug policy to racemates has not yet been proposed. (...). Whenever a drug can be obtained in a variety of chemically equivalent forms (such as enantiomers), it is both good science and good sense to explore the potential for in vivo differences between these forms.'

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