Drug Safety and Pharmacovigilance – DSPV

Adverse Events, Serious Adverse Events, CIOMS, MedWatch, MedDRA, WHODrug, PSUR

Drug-Drug Interaction

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 meantime,watch this interesting TED talk

Interventional vs. Non-Interventional

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)

Commonly used abbreviations in Pharmaceutical Industry

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 subject safety and privacy as well as provide assurance that the clinical data meet quality requirements and are fit for purpose. This includes direct (on site) review and verification but also distributed or centralized intra- and inter-site data checks in order to identify trends, signals etc. These activities are usually documented in one or more manuals or plans (such as the CDMoP, DMP, SAP, etc.)
DMP
Data Management Plan
DSci
Data Science –Analytical role enabling the creation of data products that tackle all aspects of a problem, from initial data collection and data conditioning to drawing conclusions across programs
EMA/GCP/INS
European Medicines Agency Good Clinical Practice Inspectors Group
FDA
Food and Drug Administration
GCP
Good Clinical Practices
GxP
Abbreviation for the basket of regulatory guidance for clinical, laboratory, and manufacturing practices

GPvP

Good Pharmacovigilance Practice

ITT
Intent to Treat
IVRS/IWRS
Interactive Voice/ Web Response System
QA
Quality Assurance
QC
Quality Checks Risk-Based Approach
rSDV
Reduced Source Document Verification
SDR
Source Document Review – Process of holistic review of documentation for patient data as indicated by the protocol, e.g. real subject, documents maintained, investigational product.
SDV
Source Document Verification – Process of point-to-point verification of site data entry values between source and database
SAP
Statistical Analysis Plan

STS 

(drug safety ) Signal Tracking System

 

What is BI Publisher?

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.  Report can have All Concomitant drugs separated by comma (,)  as a row level column.

So, create a layout in Microsoft word.

Bring the layout in to OBIEE

Integrate a report in to BI layout.

 

Reporttype  Caseno  Initialreceiptdate  Age  Ageunit  Gender  Prodname  Drugtype  Patid
G V IFREPORTTYPERS F CASENO INITIALRECEIPTDATE AGE AGEUNIT GENDER PRODNAME DRUGTYPE PATID E
Total by Report Type REPORTTYPE  is CASENO E
Grand total CASENO

Argus Analytic – What is it?

What is Argus Analytic?

Its a reporting environment for Argus safety application.  Oracle integrated the OBIEE (Oracle Business Intelligence Enterprise Edition) an Oracle report development tool with Argus application for reports creating and publishing.

Drag and drop User interface lets the User choose the column needed to build a simple report.

Complex reports (meaning the output format is busy) can be built via BI Publisher.

Sample outputs are coming up..

Here is the link for Argus documentation

http://www.oracle.com/technetwork/documentation/hsgbu-safety-407502.html

 

Empirica Signal and Topics

Empirica Signal

Empirica Signal and Topics:

Long topic… in a nutshell,  use “Empirica Signal and Topics” application (hosted by Oracle) to find Safety Signal in the FDA’s AERS data and WHO Vigibase data.

  • Create a topic (Example. To find “fabriel neutropenia” in Oncology_Drug_1)
  • Search for Signals
  • Track the signal
  • Share the signal with your group for review and comments.

Related topics:  vigibase , AERS

What is NOS in MedDRA Preferred Terms? Why do they use it?

What is NOS in MedDRA Preferred Terms? Why do they use it?

Example:

Abdominal hernia NOS
Abdominal hernia NOS gangrenous
Abdominal hernia NOS, obstructive

Blood alkaline phosphatase NOS
Blood alkaline phosphatase NOS abnormal
Blood alkaline phosphatase NOS decreased
Blood alkaline phosphatase NOS increased
Blood alkaline phosphatase NOS normal

Why do they do it?