Clinical research

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Clinical research

  1. 1. Clinical Research
  2. 2. Preclinical Study• Before testing on humans• Either in vitro or in vivo• Toxicology• Pharmacology• Metabolism• Bio analysis• Pharmaceutical analysis• Biosafety
  3. 3. Clinical Trials• Systematic Study od Pharmaceutical Products• On Humans :Patients OR Non- Patient Volunteers• Verify Clinical,Pharmacological and Adverse Effects• Determine Safety and Efficacy
  4. 4. Phase I• Human/Clinical Pharmacology Trials• Maximum Tolerated Dose• Pharmacodynamic,Pharmacodynami cs,• Adverse Reactions:Nature & Intensity• Healthy Adult Volunteers
  5. 5. Phase II• Exploratory Trials• Limited Number of Patients• Possible Therapeutic Uses• Effective Dose Range• 10-12 Patients at Each Dose• Safety and Pharmacokinetics
  6. 6. Phase III• Confirmatory Trials• Efficacy and Safety in larger number of patients• Comparision: Standard Drug/Placebo• Adverse Drug Reactions and Efficacy• Atleast 100 patients over 3-4 centers
  7. 7. Phase IV• Basis: Product characteristics on which Market Authorisation was granted• Post-marketing surveillance• Assessment of therapeutic value• Treatment strategy and safety profile• Explore New indications New methods of administration or Combination

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