The EU Clinical Trials Directive (CTD) has been fully implemented in The Netherlands. Prior to beginning a clinical trial, an identical Clinical Trial Application (CTA) dossier must be submitted to an accredited Ethics Committee (EC) and to the Central Commission on Research in Humans (the Competent Authority [CA] in The Netherlands). By law, the Dutch CA performs an abbreviated CTA review within 14 days.
Pharmacokinetic Charcateristic of Oral_Intranasal Morphine ARER
Extended-release (ER) opioid formulations are often targeted for misuse and abuse because they contain high amounts of opioid. An oral…
A Retrospective Analysis of the Effects of Protocol Design on Completion Rates in Outpatient Clinical Trials in Subjects with Schizophrenia or Schizoaffective Disorder
Subject attrition from randomized Schizophrenia trials is a significant problem and has been found in a meta-analysis to be as high as 76%. The…
Targeting Patients In A Complex Phase II Rheumatoid Arthritis Study
Targeting Patients In A Complex Phase IIa Rheumatoid Arthritis Study.