As the number of approved clinical trials
in India continues to taper off compared to years past, a government
task force is now calling for a new expedited trial approval process.
Saturday, 19 September 2015
Viral Clearance for Biopharmaceuticals
Viral clearance studies are mandated prior to entering clinical trials
and for commercial launch of biopharmaceuticals. These studies are a
key component of risk mitigation to reduce the potential for iatrogenic
transmission of pathogenic viruses. This paper reviews regulatory
guidance and practical strategies for designing viral clearance
studies. Essential elements for a developmental phase-appropriate viral
clearance package are detailed.
Read More
NDA for first tablet with stomach-activated digital sensor
A Japanese company has filed the first US
FDA application for a drug with an embedded sensor which can tell
doctors if patients have taken their pills.
Read More
Top three reasons to go further with MPI Research
Cardiovascular disease, which includes coronary and
peripheral artery disease, stroke,myocardial infarct and congestive
heart failure, continues to be the leading cause of death worldwide.
Despite the clear potential for impacting human health, drug discovery
and device development in this area has been hampered by challenges in
developing predictive preclinical models for use in evaluating the
efficacy and safety of potential therapeutics. Furthermore, the
extensive range of techniques, models, and assessments relevant for drug
or device development in this space required expertise with these
models and can be time consuming. Read More
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