Safety Issues in Metallic drugs
Dr. P. Sathiyarajeswaran
Dr. M. Kannan
Dr. K. Gopakumar
Central Council for Research in Siddha
Rationale in using metallic drugs
What are all the Do’s and Dont’s
What are all the possible side effects
How to choose a efficacious, non toxic SOP
Which anti dotes are available in literature
Safety studies - Protocol
Pre clinical – Standardization
Animal studies – Efficacy testing
Phase 1 trial
Human healthy volunteers
Males are preferred
Occupationally hazard free subject
Out come socially Viable
Traditional standards- Organoleptic / Five senses
Develop our own standards for High order Forms
Ligands / Chelating testing
First step in drug manufacturing.
Select the best process.
Is purification alone enough.
Understanding the risk in Phase I
Out come benefit
Aya brinuga raja karpam
Minimal sample size
No enzymatic / Sonological Changes
Quality of life Prospectively observed.
To end with
Half baked cakes reach the masses.
Physicians have to think out of the box.
A Metallic study without Clinical trial testing will end up in Bias results.
Use metallic drugs as much you can but Rationally.
Thank you all…