Document details
| 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 |
| First published | 15/03/2013 |
| Last updated | 15/03/2013 |
| Consultation start date | 15/03/2013 |
| Consultation end date | 15/09/2013 |
| Email address for submissions | pkwpsecretariat@ema.europa.eu |
Summary
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.