রবিবার, জুলাই ২৫, ২০২১

Stages of New drug development

Stages of New drug development

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Development of a new prescription drug by an innovator company is a matter of huge investment. Currently it costs about 2.6 billion USD which is equivalent to more than 200 billion Bangladeshi Taka (1/15th of total budget of Bangladesh). Not only this huge money which is invested, it takes about 10-15 years to come to the market from its initial stage of development.

After a new potential compound is discovered or synthesized, it goes through pre-clinical investigations in test animals such as mice, rabbits, dogs etc. After confirming its safety in animals, it enters into clinical trial stages which occurs in four phases: Phase -1, 2, 3 which involves human volunteers and phase 4 in which drugs are monitored in the market after large production. The total process of a new drug development is a combined effort of drug discovery scientists, doctors, pharmacists, nurses, technicians, social workers and most importantly the human volunteers to receives the novel drugs inspite of potential risks.

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The top pharmaceutical companies which invest in new drug development (also called innovators) include Pfizer (USA), Novartis (Switzerland), Sanofi (France), Roche Holding (Switzerland), Merck and Co. (USA), GlaxoSmithKline (UK), AstraZeneca (UK), Eli Lilly & Co. (USA), Abbott Laboratories (USA) etc. (named according to their net market capitalisation, assets, sales and profit).

Due to the huge investments needed the large local pharmaceutical companies in our country such as Square, Beximco, Incepta etc. are not currently investing any money in drug development process. They only develops formulation, manufacture and sell pharmaceutical dosage forms. However, we hope in future they will also be able to invest in research and drug development.

 

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