ONIVYDE® (PEP02, MM-398, nal-IRI) has received marketing authorizations in Taiwan, US, Europe and other countries for the treatment of metastatic pancreatic cancer patients who progressed on gemcitabine.
PEP07 is an oral small molecule drug with high potency and selectivity. The major working mechanism of PEP07 is to regulate DNA damage response (DDR) through inhibiting Checkpoint kinase 1 (CHK1). PEP07 is in preclinical development stage.
The clinical trial or study design is a key aspect of the successful conduct of clinical trials. It involves deciding parameters such as the number of patients, the length of the trial, the comparator arm (in the case of randomized controlled trials) using information on current treatments, the anticipated effect of the therapeutic intervention being studied and applying biostatistics methods.
Usually, a phase III study which presents the data that regulatory agencies use to decide whether or not to approve a drug.
A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
Safety Vigilance or Pharmacovigilance (PV) is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
The aims of PV are to enhance patient care and patient safety in relation to the use of medicines and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.