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Dr.U.P.Rathnakar
MD.DIH.PGDHM
Pharmacovigilance
Actively look for adverse drug effects Activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem Causality assessment 1. Temporal relationship 2. Previous knowledge 3. Dechallenge 4. Rechallenge
Information collected by Regional centers to Zonal centers to National centers to Uppsala monitoring center (Sweden)
Unknown drug
Unknown drug
Known drug with Known concentration Eg.300mg/1ml 1ml relieves head ache in 10 minutes
Bio assay
Aspirin
Grand mothers bitter decoction
ACH
Unknown
Compare
Compare
Bioassay
Acetylcholine [Standard]
Measurement of the potency [Concentration] of a drug from the magnitude of its main biological effect
Bioassay uses
Acetylcholine [Standard]
1. To measure pharmacological activity of new substances 2. To measure concn. Of new substance 3. ED50 and LD50 calculations 4. Standardization of drugs in natural sources when same cam not be done by other methods Eg.Bioassay of unknown solution is done against the effects of Ach Known [Ach]in frog rectus.
[Principles of pharmacology by Sharma & Sharma]
Carbidopa levodopa
The combination of two different drugs in a single pharmaceutical formulation Two drugs in a tablet, injection syp.etc
FDCs should not be prescribed unless: 1. There is reason to believe that pt. needs all the drugs in the combination 2. PK parameters match
Thank you!