Pharmacovigilance is one of the most significant and interesting concept of the Pharmacy field. The word Pharmacovigilance is derived from two different words i.e. "PHARMAKON" (a Greek word) meaning "Medicinal Substance" and "VIGILIA" (a Latin word) meaning "to keep watch". WHO defines it as " the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/ vaccine related problem." Meaning, it is all about collecting the safety data of the marketed drugs, managing them and analyzing any suspected information for the risk-benefit ratio. HISTORY There is a long history behind the development of this concept, which will be discussed here in the subsequent paragraphs. 1. In Jan 29, 1848, a young girl, from England, died after she got operated for removing an infected toe-nail. The reason behind the death was not known. • This incident didn't raise any concern am...
Nowadays, a lot of medicines are available in the market for treating various medical conditions and they are being used by the people on a wide scale. Anyone ever wondered, how much efforts, trials, money and time it takes to discover, develop, manufacture and sale that medicine. Well, it would all be discussed here. Before any medicine reaches market, it has to pass through various critical testing stages. This stages are designed to check whether the medicine is safe, effective for intended purpose and to find out suitable dose and dosage form for the medicine. The milestones in the journey of medicine could be named as follows: Discovery and Development Pre-clinical Research Clinical Research FDA Drug Review Marketing & Post-Marketing Surveillance It may take about 10-15 years to complete this journey and then, finally, the medicine reaches the market for the use in patients. Lets have a brief look at the journey: 1. Discovery and Development This initial step involves a lot o...