Pharmacodynamics. MBBS Class-5

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    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 assessment1. 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)

    Definite, probable, possible or doubtful

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    Quantitative estimation of a

    drug

    Unknown drug

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    Quantitative estimation of the

    drug

    Bio-assay[Biological method]

    Chromatography, spectrophotometry,

    fluorometry etc.

    Radio-immunological method

    Microbiological method

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    Quantitative estimation of a

    drug

    Unknown drug Known drug with

    Known concentrationEg.300mg/1ml

    1ml relieves head ache in 10 minutes2ml relieves head ache in 10 minutes

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    Bio assay

    Quantitative estimation of adrug in an unknown sample by

    biological method

    Aspirin

    Grand

    mothers

    bitter

    decoction

    Compare

    Unknown

    Compare

    ACH

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    Bioassay

    Acetylcholine

    [Standard]

    Unknown

    [Suspected to

    have Ach action]

    Compare

    Calculate concn.

    Measurement of the potency[Concentration] of a drug from

    the magnitude of its mainbiological effect

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    Bioassay uses

    Acetylcholine

    [Standard]

    Unknown

    [Suspected to

    have Ach action]

    Compare

    Calculate concn.

    1. To measure pharmacologicalactivity of new substances2. To measure concn. Of new

    substance3. ED

    50

    and LD50

    calculations4. Standardization of drugs in

    natural sources when same camnot be done by other methods

    Eg.Bioassay of unknown solution isdone against the effects of AchKnown [Ach]in frog rectus.

    [Principles of pharmacology by Sharma &Sharma]

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    Fixed Dose Combinations

    [FDCs]

    Carbidopa

    levodopa

    The combination of two different drugs in a

    single pharmaceutical formulation

    Two drugs in a tablet, injection syp.etc

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    Fixed Dose Combinations

    [FDCs]

    It is not simultaneous administration of two

    drugs for a disease

    It should be logical [Only about 20 are WHO approved]

    Advantageous

    Should not be dangerous

    Equal t Dose should be complimentary to plasma

    concentration

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    Fixed Dose Combinations

    [FDCs]

    Advantages

    Convenience of dosage-

    better compliance

    Synergism Reduced bacterial resistance

    Minimization of side effects

    Disadvantages

    Independent dose

    adjustments not possible

    If PK characteristics do notmatch-plasma concentration

    fluctuate

    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

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    Thank you!