safety studies in metallic drugs

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
When
How much
How long
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
Toxicological profiling
Phase 1 trial
Enzymatic
Sonologic
Tissue Biopsy
Bone teeth
LFT/KFT

Phase 1
Safety
Human healthy volunteers
Males are preferred
Non addictive
Occupationally hazard free subject
CTRI Compulsory
Out come socially Viable
Standardization
Traditional standards- Organoleptic / Five senses
PLIM Standards
Develop our own standards for High order Forms
Nano studies
Chemical Profiling(XRD/SEM/TEM/ICPMS/ICPOES)
Ligands / Chelating testing
Purification understanding
First step in drug manufacturing.
Select the best process.
Is purification alone enough.
Detoxification.
Ore dressing.
Debris removal

Understanding the risk in Phase I
IEC Approval
Pre screening
Consent
Compensation
Out come benefit


Our experience
Linga chenduram
Aya veeram
Aya brinuga raja karpam
Phase II
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…