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Case study project 1 Case study project 1 Presentation Transcript

  • IND CASE STUDY NITHYA RAJANRGA 6201:New Drug Development Mid-Term Writing Assignment
  • IND CASE STUDY NITHYA RAJANRGA 6201:New Drug Development Mid-Term Writing Assignment
  • CASE: IND for a new Anticoagulant Product is Novel Oral anticoagulant in a class of Direct Thrombin Inhibitors Existing anticoagulants are limited by a narrow therapeutic window and highly variable dose-response relation Planned study is Phase 1 PK/PD study, multi center A Pre-IND request was not submitted
  • CASE: IND for a new Anticoagulant Product is Novel Oral anticoagulant in a class of Direct Thrombin Inhibitors Existing anticoagulants are limited by a narrow therapeutic window and highly variable dose-response relation Planned study is Phase 1 PK/PD study, multi center A Pre-IND request was not submitted
  • FDA IND Review - Preclinical studies submitted Final study reports for nonclinical pharmacology and toxicology studies submitted in the IND. Pharmacology screening in vitro and in vivo assays Pharmacodynamics & Pharmacokinetics quantitative data on drug compound systemic exposure of the drug Drug Absorption, Distribution, Metabolism and Excretion
  • FDA IND Review - Preclinical studies submitted Final study reports for nonclinical pharmacology and toxicology studies submitted in the IND. Pharmacology screening in vitro and in vivo assays Pharmacodynamics & Pharmacokinetics quantitative data on drug compound systemic exposure of the drug Drug Absorption, Distribution, Metabolism and Excretion
  • FDA IND Review - Preclinical issues identified Acute Toxicity studies are missing Identify species-specific differences in toxicology in vitro and in vivo assays Summary of Pharmacological and Toxicological effects of the drug in animals incomplete
  • FDA IND Review - Preclinical issues identified Acute Toxicity studies are missing Identify species-specific differences in toxicology in vitro and in vivo assays Summary of Pharmacological and Toxicological effects of the drug in animals incomplete
  • FDA IND Review - Clinical data submitted Outline of the investigation protocol was submitted with an estimated number of participating test subjects. Dosing plan and duration Monitoring of vital signs and blood chemistry of test subjects Prothrombin time assay to monitor therapy on a daily basis International Sensitivity Index used to measure and compare the variability in thromboplastin responsiveness
  • FDA IND Review - Clinical data submitted Outline of the investigation protocol was submitted with an estimated number of participating test subjects. Dosing plan and duration Monitoring of vital signs and blood chemistry of test subjects Prothrombin time assay to monitor therapy on a daily basis International Sensitivity Index used to measure and compare the variability in thromboplastin responsiveness
  • FDA IND Review - Clinical issues identified Proposed Phase 1 trial is a open-label, single center, PK/PD study Evaluate safety and anticoagulation activity of the new drug compound in humans Primary outline of the investigation Toxicity based stopping or dose adjustment rules missing
  • FDA IND Review - Clinical issues identified Proposed Phase 1 trial is a open-label, single center, PK/PD study Evaluate safety and anticoagulation activity of the new drug compound in humans Primary outline of the investigation Toxicity based stopping or dose adjustment rules missing
  • FDA IND Review - CMC issues identified CGCP compliance not provided for Phase I Manufacturer must produce the drug in a qualified facility, using laboratory equipment that has been qualified and validated.
  • FDA IND Review - CMC issues identified CGCP compliance not provided for Phase I Manufacturer must produce the drug in a qualified facility, using laboratory equipment that has been qualified and validated.
  • Initial IND 30 Day Review Cycle Complete Clinical Hold issued (21 CFR §312.42(b)(i)) The IND does not contain sufficient information required under federal regulations to assess the risks that the proposed studies present to subjects. Investigator Brochure is materially incomplete Telephone call placed with sponsor Letter sent to sponsor within 7 calendar days of telephone call
  • Initial IND 30 Day Review Cycle Complete Clinical Hold issued (21 CFR §312.42(b)(i)) The IND does not contain sufficient information required under federal regulations to assess the risks that the proposed studies present to subjects. Investigator Brochure is materially incomplete Telephone call placed with sponsor Letter sent to sponsor within 7 calendar days of telephone call
  • Resolution: Pre-Clinical issuesSponsor conducted in vitro and in vivo toxicitystudies in mice and rabbits.Sponsor submitted a complete Summary ofPharmacological and Toxicological effects of the drugfor Investigators Brochure.
  • Resolution: Pre-Clinical issuesSponsor conducted in vitro and in vivo toxicitystudies in mice and rabbits.Sponsor submitted a complete Summary ofPharmacological and Toxicological effects of the drugfor Investigators Brochure.
  • Resolution: Clinical issuesSponsor included dose adjustment rules in the investigationSponsor amended the protocol to include single dose andescalated dose studies within the investigation
  • Resolution: Clinical issuesSponsor included dose adjustment rules in the investigationSponsor amended the protocol to include single dose andescalated dose studies within the investigation
  • Resolution: CMC IssuesCGCP Compliance Sponsor implemented appropriate QC procedures Established an acceptance criteria for control components implemented manufacturing controls at appropriate stages of drug development
  • Resolution: CMC IssuesCGCP Compliance Sponsor implemented appropriate QC procedures Established an acceptance criteria for control components implemented manufacturing controls at appropriate stages of drug development
  • Response to FDASponsor responds to the Clinical hold Faxed letter labeled “ Clinical Hold Complete Response” to the division project manager.Discusses unresolved issues with FDA reviewersClinical Hold is removed
  • Response to FDASponsor responds to the Clinical hold Faxed letter labeled “ Clinical Hold Complete Response” to the division project manager.Discusses unresolved issues with FDA reviewersClinical Hold is removed
  • FDA IND Review - Lessons Learned I learned to request a Pre-IND meeting with the FDA beforesubmission of the IND applicationDescribe in detail Pre-clinical, Clinical investigations and CMCmeasures in supplemental documentsIt is also important to have knowledgeable RA associateshandling communication between the FDA and Sponsor
  • FDA IND Review - Lessons Learned I learned to request a Pre-IND meeting with the FDA beforesubmission of the IND applicationDescribe in detail Pre-clinical, Clinical investigations and CMCmeasures in supplemental documentsIt is also important to have knowledgeable RA associateshandling communication between the FDA and Sponsor