安徽医科大学国际教育学院教案与讲稿 Applications of Clinical Pharmacokinetics 20min 1.Rational dose selection in therapeutics Target concentration strategy ESTIMATE INITIAL DOSE TARGET LEVEL LOADING DOSE MAINTENANCE DOSE BEGIN THERAPY 0 ASSESS THERAPY PATIENT RESPONSE DRUG LEVEL REFINE DOSE ESTIMATE ADJUST DOSE 2.Clinical Pharmacokinetics in Drug Development Initial PK studies in humans Late PK studies in humans Therapeutic drug monitoring Clinical (Human)Testing Preclinical testing Dose response Population PK/PD trials a品。 m PK-guided Post- Dose Efficacy PK/PD in marketing In vitro PKPD esc alation Special surveillance Animn al PK/PD Safety Dosage selection populations 具分Assessment Patient variables Toxicity Animal Phase I PhaseⅡ PhaseⅢ testing [Study Questions] 7min 1.For a drug such as piroxicam with a 40-hour half life and being dosed once daily (i.e.,every 24 hours),steady state will be reached shortly following which DOSE(not which half-life)? (A)1st dose (B)3rd dose (C)5th dose (D)8th dose (E)12th dose 2.The addition of glucuronic acid to a drug: A.Decreases its water solubility. B.Usually leads to inactivation of the drug. C.Is an example of a Phase I reaction. D.Occurs at the same rate in adults and newborns. E.Involves cytochrome P450. 3.A drug,given as a 100-mg single dose,results in a peak plasma concentration of 20ug/mL.The 5安徽医科大学国际教育学院教案与讲稿 5 [Applications of Clinical Pharmacokinetics] 20min 1. Rational dose selection in therapeutics Target concentration strategy 2. Clinical Pharmacokinetics in Drug Development
Initial PK studies in humans
Late PK studies in humans
Therapeutic drug monitoring [Study Questions] 7min 1. For a drug such as piroxicam with a 40-hour half life and being dosed once daily (i.e., every 24 hours), steady state will be reached shortly following which DOSE (not which half-life)? (A) 1st dose (B) 3rd dose (C) 5th dose (D) 8th dose (E) 12th dose 2. The addition of glucuronic acid to a drug: A. Decreases its water solubility. B. Usually leads to inactivation of the drug. C. Is an example of a Phase I reaction. D. Occurs at the same rate in adults and newborns. E. Involves cytochrome P450. 3. A drug, given as a 100-mg single dose, results in a peak plasma concentration of 20µg/mL. The