Transcription of Guideline on the pharmacokinetic and clinical …
{{id}} {{{paragraph}}}
Example: bachelor of science
Guideline on the pharmacokinetic and clinical …
1 London, 21 February 2013. 2 EMA/CHMP/EWP/280/96 Rev1. 3 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP). 4 Guideline on the pharmacokinetic and clinical evaluation 5 of modified release dosage forms 6 (EMA/CPMP/EWP/280/96 Corr1). 7 Draft XXIII. Draft Agreed by Pharmacokinetics Working Party October 2012. Adoption by CHMP for release for consultation 21 February 2013. Start of public consultation 15 March 2013. End of consultation (deadline for comments) 15 September 2013. 8. 9 This Guideline replaces Guideline on Modified Release Oral and Transdermal Dosage Forms Section II. 10 ( pharmacokinetic and clinical evaluation (EMA/CPMP/EWP/280/96 Corr*)). 11. Comments should be provided using this template. The completed comments form should be sent to 12. Keywords Modified release, prolonged release, delayed release, transdermal drug delivery systems (TDDS), bioequivalence, pharmacokinetics, biowaiver, in vitro dissolution, generics 13.
Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) 4/38 69 Executive summary
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: