Α ΡΙΣΤΟΤΕΛΕΙΟ Π ΑΝΕΠΙΣΤΗΜΙΟ Θ E ΣΣΑΛΟΝΙΚΗΣ Ι ΑΤΡΙΚΗ Σ ΧΟΛΗ

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  • E

    MD, Bpharm, FRCGP, PhD

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  • 1.100

  • Fortunately a surgeon who uses the wrong side of the scalpel cuts his own fingers and not the patient; if the same applied to dugs they would have been investigated very carefully a long time ago.

    Rudolf BucheimBeitrage zur Arzneimitetellehre, 1849

  • World Pharma, 2010, Copenhagen, DenmarkZintzaras & Ioannidis. J Antimicrob Chemother 2003; 52: 1001-1004

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  • (%) (Cmax) (tmax) (AUC) (Vd) (t1/2) (CL) (CL=0,693 x Vd/ t1/2) (% / )

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  • . ( ) 50% 25% .

  • (fu) (fu=1, Drug Cl Creatinine Cl) , , fu ( ).. fu=0,5 50% . = 1/2 . 75% .

  • 1. (fu). 0,5 < fu < 1 2. (CrCl)

    (140 - ) x (kg)CrCl (ml/sec) = ( x 0,85) 50.000 x Cr (mmol/L)

    CrCl > 1,5 ml/sec CrCl ml/min 50.000 8153. DR () CrCl () = (1-fu) + fu x DR () 1,5

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  • .V.AUCCmaxT1/2Cmax/2

  • p.osAUC = 5,25 ng*h/mlCmax = 0,630 ng/ml (3h)T1/2 = 6,9hCmax/2

  • .V.AUCCmaxT1/2Cmax/2

  • p.osAUCCmaxT1/2Cmax/2

  • Mission impossible !!!

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  • ~100 Phase IPhase IIPhase III015510 1000-5000 250 7,000,000

    1 5 Sources: 1) Increased Length and Complexity of the Research and Development Process. Chapter 1 in: PhRMA Pharmaceutical Industry Profile 2003. 2) DiMasi, JA, Hansen, RW, Grabowski, HG. The Price of Innovation: new estimates of drug development costs. Journal of Health Economics. 2003; 22:151-185.

  • 24 () 25% ( GMP) (, , / )

  • AUCCmaxT1/2Cmax/2

  • AUCCmaxT1/2

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  • Docetaxel 21 < 90%11 < 80% 1 < 40%pH ( )

  • ;Generic substitutes are neither as safe nor effective as branded medications: experience in men treated for lower urinary tract symptoms" Steven Kaplan, AUA 2009

  • WARNING!!! Sometimes what is shown is not what it seems!

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  • , !!! 80%

    40% , 50% ( ...)

    !!!

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  • & !

    Alban Feinstein

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