360 likes | 488 Vues
This document provides a comprehensive overview of the Pharmacy 732 course for Winter 2003, detailing instructors, exam schedules, grading criteria, remediation policies, and classroom conduct. Students will have three main exams worth 100 points each, alongside quizzes and workshop participation. Specific guidelines for remediation and make-up exams are outlined for students scoring below a passing grade. Key course materials include "Clinical Pharmacokinetics" by Rowland and Tozer, along with WebCT resources for lecture notes and exam keys.
E N D
Pharmacy 732 Winter 2003
Instructors • William Hayton Pharmaceutics • James Coyle PPAD • Cari Brackett PPAD • Kristin Lugo PPAD • Juhyun Kim Pharmaceutics
Exams • 3 Exams, 100 points each • Exam 1: Tues. Jan. 28, • Exam 2: Tues. Feb. 18, • Exam 3: Tue. March 18, 9:30 – 11:18 • Quizzes, – seven total, 15 points each, drop the lowest score - 90 points • Workshop participation - 10 points • Total:---------------------------------- 400 points
Grading Total Points 4
Remediation and Make-Up • Exams 1 & 2 will be offered again during the 10th week class. • Remediation • Open to all students; manditory for students scoring <67. • Scoring: 0.2 x first score + 0.8 x second score • (0.2)(65) + (0.8)(85) = 81 • Make-Up • If exam was missed for a qualified reason, full score will count; if not, remediation scoring will be used with the first score being zero.
Post-Course Remediation • Course average between 60.0 and 66.9 • Eligible to take a comprehensive exam over Pharmacy 732 during workshop of the first week of Pharmacy 733. • 67.0: C- for the course • <67.0: E for the course • Course average <60 • No post-course remediation allowed and E grade stands.
Workshops • Monday Afternoon, 1:30 – 3:18 • Rm. 550 • Rm. 257 • Wednesday Afternoon 1:30 – 3:18 • Rm. 550 Parks Hall • Rm. 257 Parks Hall
Course Materials • Clinical Pharmacokinetics, Rowland and Tozer, third edition • Calculator • Semilog graph paper • Course Pack
Classroom Conduct • Quiet is appreciated • Cell phones turned off • Pagers in quiet mode • Refrain from exiting and re-entering
Academic Misconduct: Exams • No caps • No use of memory in calculators • No PDAs, laptops, etc. • No exchanging information with others • No cell phones or pagers in “on” mode • No crib notes, cheat sheets, etc.
WebCT • Course Materials • Slides from class • Narrated slides from class • Reference materials; e.g., PK parameters • Exam Keys old and current • Quiz Keys old and current • Bulletin board • Email • Quiz and exam scores; i.e., grade book • Self tests • Student home page - optional
WebCT Logon • (1) Open a web browser and go to: http://class.osu.edu • (2) Log on: • Enter your “username” and “password.” • Username = lastname.123 (all lowercase, No CAPITAL LETTERS!) • Example: If your E-mail address is smith.303@osu.edu = Username is “smith.303” • Password = same one you use to check your OSU e-mail, to register online for classes, and to enable Internet access in OIT student computer labs.
Dosing Regimen Design Infusion regimen
Why is a dosing regimen necessary? • To replace the drug that the body eliminates. How can drug be replaced? • Continuously or intermittently.
Continuous Input • Learning Objectives • input rate to achieve a desired plasma concentration. • kinetics of accumulation; i.e., how long to steady state. • loading dose. • determination of CL, V, KE and t1/2.
Examples of continuous input • i.v. drip • i.v. infusion • transdermal patch • sustained release oral dosage forms • Ocusert • Norplant
Ko v CL Kinetics of continuous input A = amount of drug in body Cp = plasma concentration Ko = input rate (amt/time) KE = elimination rate constant, (CL/V) dA/dt = rate in - rate out dA/dt = Ko - KEA A = V x Cp and KEV = CL dA/dt = Ko - CL•Cp dA/dt = 0 at a plateau Cp Rate In = Rate Out Ko = CL •Cp,ss Cp,ss = Ko/CL
young Ln Cp old Time Example: Diazepam Cp,t profile in young and old: DR adjustment? What’s different? Herman and Wilkinson. Br. J. Clin. Pharmacol. 42:147,1996. #2919
Principles • When infused at the same rate (one compartment model assumed): • all drugs with the same half life will have the same steady-state amount of drug in the body. • all drugs with the same clearance will have the same steady-state plasma concentration.
Time to steady state 3.3 t1/2 is time to 90% of Cp,ss t = nt1/2 where n = no. of half lives that have passed
Example This drug has a V = 45 L and a CL = 12 L/h. What infusion rate is needed to achieve a Cp,ss of 25 mg/L? Ko = CL x Cp,ss = 12 L/h x 25 mg/L = 300 mg/h How long will it take to get to 90% of steady state? t1/2 = ln 2 V/CL = (0.693)(45)/(12) = 2.6 h t90% = 3.3 t1/2 = (3.3)(2.6) = 8.6 h How much drug is in the body at steady state? Ass = Cp,ssV = 45 L x 25 mg/L = 1,125 mg
V Ass t90% Ko CL Css Diagram VP, VE, VR RE/I, fur, fup QH, fup, CLint,u GFR, etc.
Review With a constant rate of input, Ko Rate Out Rate In = _______ CL Rate In = Css x ___ KE Rate In = Ass x ___ All drugs with same CL will have same ____ Css Ass All drugs with same t1/2 will have same ____
CL by 25% Cp V by 25% Ko by 25% Time Changing to a new Cp,ss
Bolus and Infusion A “loading dose” may be used to start at steady state immediately. Loading Dose = Ass = Ko/KE = CssV
Time to Steady State 3.3 t1/2 is time to 90% of Cp,ss. When Cp,0 is 0, this is within ±10% of Cp,ss. When Cp,0 is 0, the time to ±10% of Cp,ss differs from the t90%. What is the appropriate endpoint for calculation of the time to steady state?
Calculation of time to ±10% Cp,ss Plasma concentration at any time after bolus + infusion: Given Cp,0 and Css, the time to reach any Cp can be calculated from:
Example Cp,0 = 500 mg/L and Css = 100 mg/L, how long does it take to reach 110 mg/L? (i.e., 110% of Css) (1/2)n = (100 – 110)/(100 – 500) = -10/-400 = 0.025 (n)[ln (0.5)] = ln (0.025) n = ln (0.025) / ln (0.5) = 5.32 half lives 140 mg/L What would be the Cp after 3.3 half lives?
-2.3 slope = KE Log (Cp,ss - Cp) Time Assessment of PK parameters 1. CL = Ko / Cp,ss 2. Get KE from the slope of a semilog plot of (Cp,ss – Cp) vs. t. 3. V = CL / KE