DRUG DEVELOPMENT PROCESS

Drugs are developed through a long-controlled process called drug development process. It’s a long and expensive process that takes a minimum of 10 years and costs from a few billions to trillions of moneys.

The process happens in 5 major stages that include discovery, pre-clinical research, clinical research, approval by FDA(Food and Drugs Administration), post marketing safety monitoring by FDA.

11.      Discovery

i)                    The physiological, cellular, and/or genetic basis of a disease is studied to identify potential therapeutic targets.

ii)                   New compounds are isolated and purified from natural sources or synthesized

22.     Pre-clinical trials

i)                    In vitro (cell-based) laboratory assays are developed to measure the effect of potential therapeutics

ii)                   Using the in vitro laboratory assay, 5,000-10,000 new and previously developed compounds are tested for biological activity

iii)                 On average, 250 of the compounds tested possess the desired activity and are now designated as “hits”

iv)                 A handful of the most promising hits are chosen for chemical modification to improve target specificity, potency, chemical and metabolic stability, water solubility, and other pharmacological parameters. Improved hits are now known as “lead compounds”

v)                   Animal trials- Lead compounds are tested in vivo for safety and efficacy, in laboratory animals such as mice and rats

After all these trials, before proceeding to human tests, a New Drug Application must be filed with the FDA

33.    Clinical trials

i)                    Phase 1- clinical trials consist of drug safety studies in healthy humans

ii)                   Phase II- clinical trials test whether a drug works in a small number of patients affected by the disease

iii)                 Phase III- clinical trials test large numbers of patients of diverse backgrounds.

44.      A New Drug Application is filed with the FDA

FDA thoroughly examine all of the submitted data related to the drug and make a decision to approve or not to approve it

55.    FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.

It monitors patent allocation and reports of unforeseen reactions reported from users, and disease resistance to the new drug