Presentation on theme: "Stages of drug development"— Presentation transcript:
1 Stages of drug development Pharmacology labMSc.Ikhlas Jarrar
2 IntroductionAverage time to develop new drug is years. On an average out of 10,000 – 30,000 potential substances only 1 could make it to the market. As per 2006 estimates, the cost of bringing a new drug could vary from 500 million to 2,000 million USD.
5 Historical Timelines : Historical Timelines Elixirsulfanilamide disasterThalidomide crisis19061938No Regulatory control for Drug safety19611937Federal Food andDrug Act passed
6 Stages in Drug Development : Drug DiscoveryPre-Clinical TestingPhase I Clinical TrialsPhase II Clinical TrialsPhase III Clinical TrialsNew Drug Application (NDA) / Biologics License Application (BLA)Phase IV and Beyond
7 Drug Discovery : Determine the target disease Determine each component of disease :SymptomsTarget organBiochemical pathwaysSearch for the target drug : -Chemically synthesized compound –Biologically synthesized compound –Computer simulated compoundIsolate the compoundProceed to next Stage
8 Pre CLINICAL TRIALS :Evaluation of acute and short term toxicity in animals. It Involves :-Lethal dose determination-Effect of dose at normal level for short/Long termAssess how the drug is absorbed/distributed/metabolized and excreted in animals.Proceed to next Stage.
9 IND programIt is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk.If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.
10 Phase 1 CLINICAL TRIALS : Begins after 30 days of filing IND.Drug given to healthy volunteersDuration could vary from 1 month to 1 year.Following is studied here :Drug absorption/Metabolism in human.Effect on organs and tissues. -Side affect of different dosages.Thus early evidences on effectiveness are achieved.Proceed to next Stage
11 Phase 2 CLINICAL TRIALS : Drug given to patient volunteersDuration could vary from 1 year to 2 yearsCost could vary from $10 - $100 million. Following is studied here : -Drug effectiveness in treating the disease.Short term side effects in patientsLess than 1/3rd of INDs survive phase 2Proceed to next Stage.
12 Phase 3 CLINICAL TRIALS : FDA consulted before beginning phase 3Drug given to patient volunteersDuration could vary from 3 years to 4 years.Cost could vary from $10 - $500 millionFollowing is studied here :Safety of Drug [ Benefits v/s risk analysis ] –Long term side effects in patientsProceed to next Stage.
13 NDA NDA Refers to New Drug Application Formal proposal for the FDA to approve a new drug for sale in the U.S.Sufficient evidences provided to FDA to establish:Drug is safe and effective.Benefits outweigh the risks.Proposed labeling is appropriate.
14 Market Launch/Phase 4 : launched to the Market Additional post marketing testing of patients toSupport the use of the approved indicationFinding new therapeutic opportunitiesExtending use of the drug to different classes of patients like children