Pharmcovigilance is the pharmacological
science and activities relating to the assessment, understanding, detection and
prevention of adverse effects or any other drug related problem. Pharmacovigilance
has a major role to improve public health and safety in relation to drugs and
to contribute in the assessment of benefits, effectiveness and risk of drugs,
encouraging their safe, rational and more effective use. It is also to promote
education and clinical trials. Its effective communication to health
professionals and the public. Before a drug launch into the market to reach the
public on time and cost-efficient manner, it passes through all phases of
clinical trials and the goal of company.
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Basic needs of pharmacovigilance relating
to tests on animals are insufficient to predict human safety due to this reason
limited number of patient are selected in clinical trials for limited duration
of time. By the time of licensing exposure of less than 5000 human subjects to
a drug allows only the common adverse drug event to be estimated. Information
about serious adverse reactions is any untoward medical occurrence that any
dose results in significant disability and death, chromic toxicity, use in
special groups such as children and pregnant woman. Main steps under
pharmacovigilance, includes identifying information about risk associated with
drugs, preventing harm to patients and post marketing surveillance. An adverse
drug reaction is a response to a medicine which is noxious and unintended, and
which occurs at normal dose.
In National Pharmacovigilance program
(NPP), the nationwide clinical trials programmed, sponsored and coordinated by
the country’s central drug regulatory agency (Central Drug Standard Control
Organization to establish and manage a data base of adverse drug reaction for
making informed regulatory decisions regarding marketing authorization of drugs
in India for ensuring safety of drugs). Functions of NPP is to monitor the adverse
drug reactions of medicines, maintain contacts with international regulatory
bodies working in pharmacovigilance and exchange information on drug safety,
assess the regulatory information about drug safety, and provide information to
end-users through adverse drug reaction news bulletins and seminars.
GAP has a team of
experts for Pharmacovigilance and immune- Oncology. We serve our customers by
creating a safety profile of the drug which helps in gathering information on
time.
For more
information contact us: www.gapsos.com
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