Cutting Drug Discovery Costs on the Subcontinent

Costs fo Drugs: Discovery-ApprovalDiscovery• Target identification• Target validation• Lead identification• Lead validationPre-Clinical Studies• In vitro validation• In vivo validationPre-Clinical Studies• In vitro validation• In vivo validationClinical Trials• Phase I trials• Phase II trials• Phase III trials• Regulatory affairsPercentages represent the total cost associated with that activityThe process of discovering new

Written byMathukumalli Vidyasagar

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• Target identification• Target validation• Lead identification• Lead validation

• In vitro validation• In vivo validation

• Phase I trials• Phase II trials• Phase III trials• Regulatory affairs

Percentages represent the total cost associated with that activity

The process of discovering new drugs and getting regulatory approval is becoming ever more costly. At present, the total turnover of the world's pharmaceutical industry is roughly $350–$400 billion, while the cost of R&D is estimated at about $45 billion per year. In comparison, R&D investment was $5 billion in 1986 and $30 billion in 2001. In spite of the significantly larger spending on R&D, the total number of new chemical entities (NCEs) approved by the US Food and Drug Administration has not shown a commensurate increase. The number of NCEs licensed in a given year has remained relatively constant over the years, varying from 20 ...

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