Citaat | Gerechtshof 's-Gravenhage 24 januari 2012

Alinea 128 Gerechtshof 's-Gravenhage 24 januari 2012

Een alinea uit Gerechtshof 's-Gravenhage 24 januari 2012, ECLI:NL:GHSGR:2012:BV1963.

"The regulatory authorities are beginning to respond to the scientific and clinical maelstrom concerning the issue of racemates and enantiomers. (...) Matters are further advanced in the EEC, where at present the Committee for Proprietary Medicinal Products is considering a draft guideline statement on isomerism for inclusion in its 'Notice to Applicants'. If adopted, as looks likely, new submissions for drugs with chiral centres will have to provide information inter alia on the following points: isomer ratio and batch to batch consistency; a discussion of the toxicological and pharmacological properties of the isomers, enantiomer specific metabolism and kinetics and extrapolation of preclinical data (particularly if species differences occur in the handling of stereoisomers); and a discussion of possible clinical problems that may arise in relation to stereoisomers.'

Zelf controleren

Voor dit citaat hoeft niemand Bron op zijn woord te geloven. Het document dat rechtspraak.nl publiceerde, staat op https://bron.page/api/v1/blobs/e8978bb9a56f03d1c6a26a420e9d06118ceced8ec090bb042106f8209050b5b6. Wie het ophaalt en de SHA-256 ervan berekent, krijgt e8978bb9a56f03d1c6a26a420e9d06118ceced8ec090bb042106f8209050b5b6, en de alinea staat in dat document op bytes 37630 tot 38524.