|Download document||Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms|
|Reference number||EMA/CHMP/EWP/280/96 Rev.1|
|Status||draft: consultation open|
|Consultation start date||15/03/2013|
|Consultation end date||15/09/2013|
|Email address for firstname.lastname@example.org|
The primary purpose of this guideline is to define the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified-release and transdermal dosage forms in man and to set out general principles for designing, conducting and evaluating such studies.