PK+and+New+Drugs

PK+and+New+Drugs - PKandNewDrugs NCEtoaDrug...

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PK and New Drugs
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NCE to a Drug PK parameters in package insert From what are they derived First-in-Man – Phase I How is dose determined from pre-clinical Dose Escalation
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Pre Clinical Data PK data to support drug development Poor PK a major cause of drug failure in clin  trials Extensive Data on rodents (typically) Scale to human Allometric Scaling: Y=aB x   If x=1 it’s linear (e.g. liver wt a constant fraction of  body wt) If x=~0.7 – it’s a function of surface area or like Lung ventilation, cardiac output, metabolism most “rates” Works out within +/- 2-fold for 90%
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The 5 fundamental: F, ka, V D , Cl R,  Metabolism – Cl Human hepatocytes cDNA-expressed human CYPs Human microsomes Absorption/F Cultured Caco-2 cells Know QH, est. metabolism   Cl H , 1 st  pass
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This note was uploaded on 08/26/2010 for the course PHRM 231 taught by Professor N/a during the Fall '07 term at UConn.

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PK+and+New+Drugs - PKandNewDrugs NCEtoaDrug...

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