Your SlideShare is downloading. ×

Clinical research

254
views

Published on


0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
254
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
10
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. Clinical Research
  • 2. Preclinical Study• Before testing on humans• Either in vitro or in vivo• Toxicology• Pharmacology• Metabolism• Bio analysis• Pharmaceutical analysis• Biosafety
  • 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. Phase I• Human/Clinical Pharmacology Trials• Maximum Tolerated Dose• Pharmacodynamic,Pharmacodynami cs,• Adverse Reactions:Nature & Intensity• Healthy Adult Volunteers
  • 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. 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. 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