The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. EMA protects public and animal health in 28 EU Member…
Read more
European database of suspected adverse drug reaction reports Go to http://www.adrreports.eu/ Select language link. (Example for English: http://www.adrreports.eu/en/index.html) Select a Product or Substance (for example Viagra) The following screenshots shows list of ISCR received for all products ! (yes.. you heard me!) Cumulative list of Individual Cases (for All products till 30APR2017) Number of individual…
Read more
FDA Adverse Event Reporting System (FAERS) FAERS is a database that contains information on adverse event and medication error reports submitted to FDA. It contains over 9 million reports of adverse events from 1969 to the present. How did FDA collected this data? Reporting of adverse events and medication errors by healthcare professionals and consumers…
Read more
What is DILI? “Drug-induced”……liver damage. Liver is body’s waste collector. Waste from the medicine you consume would go to the Liver. What DILI would Cause: In the United States, drug-induced liver injury (DILI) is the most common cause of acute liver failure. It can occur due to ingestion of any therapeutic drug, herbal product, or…
Read more
The industry wide Signal detection challenge is to identify Drug Drug Interaction for a Serious Adverse Event. Well…. it is not that challenging when it is just Drug and Drug and an Event. The challenge comes if it is Drug Drug Drug Drug and Event and Lab value. Let us discuss in details…. in the…
Read more
CRO was using InForm for Case processing. How to upload all InForm data in to Argus? Any thoughts?….
Non-Interventional Study = Medicinal product is prescribed in the usual manner (Example: Acetaminophen only) Interventional Study = Participants are assigned to receive one or more interventions so that researchers can evaluate the effects of the interventions. (Study medication (Acetaminophen ) with Cantaloupe juice and Aspirin)
These disease areas are NOT in order. Alzheimer’s Asthma Bi-polar Disorder Breast Cancer Cardiovascular Cardio Vascular Imaging Chronic Hepatitis C COPD Diabetes Diabetic Kidney Disease Dyslipidemia General Anxiety Disorder Influenza Major Depressive Disorder Multiple Sclerosis Pain Parkinson’s Disease Polycystic Kidney Disease Prostate Cancer QT Studies Rheumatoid Arthritis Schizophrenia Traumatic Brain Injury Tuberculosis Virolog
Commonly used abbreviations in Pharmaceutical Industry ACRO Academic Research Organization CDMoP Clinical Data Monitoring Plan CRA Contract Research Associate CRO Contract Research Organization CSR Clinical Study Report CTTI Clinical Trials Transformation Initiative DM Data Manager DMon Data Monitoring – All raw and source data review activities by a sponsor that guarantee the protection of trial…
Read more
What is BI Publisher? Its a component of OBIEE (Oracle Business Intelligence Enterprise Edition) where a developer can create a layout (just the layout) for complex-layout report. Examples: The following report has two totals at the bottom. This is simple, why to use BI publisher for it? Well, its just an example of Row-level columns.…
Read more