logging in or signing up Drug Development bicsin Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 3048 Category: Science & Tech.. License: All Rights Reserved Like it (7) Dislike it (0) Added: September 22, 2009 This Presentation is Public Favorites: 8 Presentation Description No description available. Comments Posting comment... By: gbarie (10 month(s) ago) I am speaking at a career day for 7th graders and feel this presentation has some excellent information I could provide to them. Can you please a copy to gretchenbarie@yahoo.com? Saving..... Post Reply Close Saving..... Edit Comment Close By: asoundar (12 month(s) ago) Interesting. Could you please send a copy to arunsoundar@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: Shiv43 (12 month(s) ago) DEAR SIR, I would like to have this presentation for academic purposes. I will be greatful if Ireceive this presentation. Thanking you in anticipation. Saving..... Post Reply Close Saving..... Edit Comment Close By: padee (12 month(s) ago) Can i have a copy of it please/.... Saving..... Post Reply Close Saving..... Edit Comment Close By: sarah22 (12 month(s) ago) Please send me a copy of this excellent and clear presentation. Thank you. powells@ntlworld.com Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Drug Development : Drug Development Introduction : Introduction Average time to develop new drug is 10 -12 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. Life Cycle for new drug : Life Cycle for new drug Historical Timelines : Historical Timelines 1937 No Regulatory control for Drug safety Elixir sulfanilamide disaster Federal Food and Drug Act passed Stages in Drug Development : Stages in Drug Development Drug Discovery Pre-Clinical Testing Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials New Drug Application (NDA) / Biologics License Application (BLA) Phase IV and Beyond Drug Discovery [ Stage 1] : Drug Discovery [ Stage 1] Determine the target disease. Determine each component of disease : Symptoms Target organ Biochemical pathways Search for the target drug : -Chemically synthesized compound -Biologically synthesized compound -Computer simulated compound Isolate the compound Proceed to next Stage. Pre CLINICAL TRIALS [ STAGE 2] : Pre CLINICAL TRIALS [ STAGE 2] Evaluation of acute and short term toxicity in animals. It Involves : -Lethal dose determination. -Effect of dose at normal level for short/Long term. Assess how the drug is absorbed/distributed/metabolized and excreted in animals. Proceed to next Stage. Phase 1 CLINICAL TRIALS [ STAGE 3] : Phase 1 CLINICAL TRIALS [ STAGE 3] Begins after 30 days of filing IND. Drug given to 20-100 healthy volunteers Duration could vary from 1 month to 1 year. Cost could vary from $100K to $1000K 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. Phase 2 CLINICAL TRIALS [ STAGE 4] : Phase 2 CLINICAL TRIALS [ STAGE 4] Drug given to 100 - 300 patient volunteers Duration could vary from 1 year to 2 years. Cost could vary from $10 - $100 million. Following is studied here : -Drug effectiveness in treating the disease. -Short term side effects in patients Less than 1/3rd of INDs survive phase 2 Proceed to next Stage. Phase 3 CLINICAL TRIALS [ STAGE 6] : Phase 3 CLINICAL TRIALS [ STAGE 6] FDA consulted before beginning phase 3 Drug given to 1000-3000 patient volunteers Duration could vary from 3 years to 4 years. Cost could vary from $10 - $500 million Following is studied here : -Safety of Drug [ Benefits v/s risk analysis ] -Long term side effects in patients Proceed to next Stage. 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. Market Launch/Phase 4 : Market Launch/Phase 4 Drug is launched to the Market Additional post marketing testing of patients to -support the use of the approved indication. Finding new therapeutic opportunities Extending use of the drug to different classes of patients like children Questions : Questions Slide 14: THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Drug Development bicsin Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 3048 Category: Science & Tech.. License: All Rights Reserved Like it (7) Dislike it (0) Added: September 22, 2009 This Presentation is Public Favorites: 8 Presentation Description No description available. Comments Posting comment... By: gbarie (10 month(s) ago) I am speaking at a career day for 7th graders and feel this presentation has some excellent information I could provide to them. Can you please a copy to gretchenbarie@yahoo.com? Saving..... Post Reply Close Saving..... Edit Comment Close By: asoundar (12 month(s) ago) Interesting. Could you please send a copy to arunsoundar@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: Shiv43 (12 month(s) ago) DEAR SIR, I would like to have this presentation for academic purposes. I will be greatful if Ireceive this presentation. Thanking you in anticipation. Saving..... Post Reply Close Saving..... Edit Comment Close By: padee (12 month(s) ago) Can i have a copy of it please/.... Saving..... Post Reply Close Saving..... Edit Comment Close By: sarah22 (12 month(s) ago) Please send me a copy of this excellent and clear presentation. Thank you. powells@ntlworld.com Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Drug Development : Drug Development Introduction : Introduction Average time to develop new drug is 10 -12 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. Life Cycle for new drug : Life Cycle for new drug Historical Timelines : Historical Timelines 1937 No Regulatory control for Drug safety Elixir sulfanilamide disaster Federal Food and Drug Act passed Stages in Drug Development : Stages in Drug Development Drug Discovery Pre-Clinical Testing Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials New Drug Application (NDA) / Biologics License Application (BLA) Phase IV and Beyond Drug Discovery [ Stage 1] : Drug Discovery [ Stage 1] Determine the target disease. Determine each component of disease : Symptoms Target organ Biochemical pathways Search for the target drug : -Chemically synthesized compound -Biologically synthesized compound -Computer simulated compound Isolate the compound Proceed to next Stage. Pre CLINICAL TRIALS [ STAGE 2] : Pre CLINICAL TRIALS [ STAGE 2] Evaluation of acute and short term toxicity in animals. It Involves : -Lethal dose determination. -Effect of dose at normal level for short/Long term. Assess how the drug is absorbed/distributed/metabolized and excreted in animals. Proceed to next Stage. Phase 1 CLINICAL TRIALS [ STAGE 3] : Phase 1 CLINICAL TRIALS [ STAGE 3] Begins after 30 days of filing IND. Drug given to 20-100 healthy volunteers Duration could vary from 1 month to 1 year. Cost could vary from $100K to $1000K 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. Phase 2 CLINICAL TRIALS [ STAGE 4] : Phase 2 CLINICAL TRIALS [ STAGE 4] Drug given to 100 - 300 patient volunteers Duration could vary from 1 year to 2 years. Cost could vary from $10 - $100 million. Following is studied here : -Drug effectiveness in treating the disease. -Short term side effects in patients Less than 1/3rd of INDs survive phase 2 Proceed to next Stage. Phase 3 CLINICAL TRIALS [ STAGE 6] : Phase 3 CLINICAL TRIALS [ STAGE 6] FDA consulted before beginning phase 3 Drug given to 1000-3000 patient volunteers Duration could vary from 3 years to 4 years. Cost could vary from $10 - $500 million Following is studied here : -Safety of Drug [ Benefits v/s risk analysis ] -Long term side effects in patients Proceed to next Stage. 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. Market Launch/Phase 4 : Market Launch/Phase 4 Drug is launched to the Market Additional post marketing testing of patients to -support the use of the approved indication. Finding new therapeutic opportunities Extending use of the drug to different classes of patients like children Questions : Questions Slide 14: THANK YOU