PHA Final Exam. Fall On my honor, I have neither given nor received unauthorized aid in doing this assignment.

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1 Nm: PHA 5127 Finl Exm Fll 2012 On my honor, I hv nihr givn nor rcivd unuhorizd id in doing his ssignmn. Nm Pls rnsfr h nswrs ono h bubbl sh. Th qusion numbr rfrs o h numbr on h bubbl sh. Pls fill in ll h informion ncssry o idnify yourslf. Th procors will lso collc your xms. Good LUK. Qusion/ ---Poins TOTAL 110_/ps 1

2 Nm: Qusion S I (10 ps): Slc whhr h following smns r Tru (A) or Fls (B) 1: T F For bioquivlnc ss, AU is rlvn msur o ssss whhr s nd rfrnc formulion dlivr h sm dos. 2: T F For bioquivlnc ss, AU is rlvn msur o ssss whhr s nd rfrnc formulion hv h sm volum of disribuion. 3: T F For bioquivlnc ss, AU is rlvn msur o ssss whhr s nd rfrnc formulion hv h sm r of bsorpion. 4: T F For bioquivlnc ss, mx is rlvn msur o ssss whhr s nd rfrnc formulion hv h sm r of bsorpion. 5: T F For bioquivlnc ss, mx diffrs bwn s nd rfrnc formulion if boh dlivr diffrn doss (ssum sm r of bsorpion for boh formulions). 2

3 Nm: Qusion s II (6 ps): Slc from h following smns whhr h smns r Tru (A) or Fls (B). 6: T F Assum sdy s hs bn rchd fr hving srd consn r infusion. A sdy s, 0 will qul inrinsic clrnc. 7: T F Th im o rch sdy s fr consn r infusion is ffcd by h of h drug. 8: T F Assum drug givn s iv bolus vry 8 hours. I ws obsrvd h h mx dos no diffr bwn h firs hr injcions. Th hlf-lif of his drug is shorr hn 2 hours. Qusion S III (4 ps): Slc from h following smns whhr h smns r Tru (A) or Fls (B). Assum mulipl dosing siuion. 9: T F For lipophilic drug whos clrnc is consn undr h givn condiions, h following smn cn b md: Th srongr h issu binding h mor pronouncd h dgr of ccumulion. 10: T F For lipophilic drug whos clrnc is consn undr h givn condiions, h following smn cn b md: Th srongr h issu binding h smllr h flucuion bwn p nd rough concnrion. 3

4 Nm: Qusion S IV (15 ps): Pin TK, 65 g, 17 yr old boy, hs bn givn consn r infusion of hophyllin for n cu shm c. Th infusion r is 30 mg/hr. His plsm hophyllin lvl is now 12 µg/ml. Qusion 11: Assum sdy s hs bn rchd. lcul TK s clrnc. Round pproprily. (5 ps) A: 2.5 L/hr B: 2.5 L/ 0.5 hours : 2.5 L : 2.5 mg/hr E: non of h bov 4

5 Nm: Pin TK, 65 g, 17 yr old boy, hs bn givn consn r infusion of hophyllin for n cu shm c. Th infusion r is 30 mg/hr. His plsm hophyllin lvl is now 12 µg/ml. Qusion 12: Th docor wns o chng o n orl dlivry. Assum n orl biovilbiliy of 100% for hophyllin. Suggs n orl dosg rgimn h will produc n vrg sdy s concnrion of 12 μg/ml, using susind rls produc, dosd vry 12 hours (wic dy). Giv h dos in mg of hophyllin. Thr r only 100 mg bls vilbl. onsidr h h hrpuic rng is bwn 10 nd 20 μg/ml. Round pproprily. (5 ps) A: 200 mg vry 12 hours B: 300 mg vry 12 hours : 400 mg vry 12 hours : 500 mg vry 12 hours E: 600mg vry 12 hours 5

6 Nm: Pin TK, 65 g, 17 yr old boy, hs bn givn consn r infusion of hophyllin for n cu shm c. Th infusion r is 30 mg/hr. His plsm hophyllin lvl is now 12 µg/ml. Round pproprily Qusion 13: Assuming Vd of 0.5 L/g, wh is h hlf-lif in his pin fr n iv bolus injcion (ssum firs ordr liminion nd on comprmn body modl). (5 poins) A: 12 hours B: 9 hours : 24 hours : 16 hours E: Non of h bov. 6

7 Nm: Qusion S V (5 ps) Qusion 14: A 60 g pin is srd on 80 mg of gnmicin, vry 6 hr givn s on-hour infusion. Assum h sdy s hs bn rchd for his mulipl dosing siuion. If his pin is ssumd o hv n vrg volum of disribuion (vlu of h populion mn) of 0.25 L/g nd norml hlf lif of 3 hr, wh would b h plsm concnrion 1 hour fr h sop of h infusion? Round pproprily. (5 poins) A: 3.2 mg/l B: 2.5 mg/l : 0.8 mg/l : 1.2 mg/l E: Non of h bov 7

8 Nm: Qusion S VI (7 poins) Qusion 15: A 60 g pin should rciv 80 mg of drug X, vry 6 hr givn s on-hour infusion. Th hlf-lif of his drug is 4 hours. lcul loding dos givn s shor-rm infusion ovr 1 hour for his scnrio. A: 100 mg B: 200 mg 300 mg : 400 mg E: on hv nough informion o provid his informion. 8

Nm: Qusion S VII (12 ps) onsidr h following quion: Numbr bwn 1 nd 0 mns h for im unis (T, or u) bing 0, h rlvn xprssion will b 1. Th xprssion will pproch 0 for lrg im uni vlus.

9 Nm: Qusion S VII (12 ps) onsidr h following quion: Numbr bwn 1 nd 0 mns h for im unis (T, or u) bing 0, h rlvn xprssion will b 1. Th xprssion will pproch 0 for lrg im uni vlus. Numbr bwn 0 nd 1 mns h for im unis (T, or u) bing 0, h rlvn xprssion will b 0. I will pproch 1 for lrg im uni vlus. Slc h pr of h quion (A, B,, ) h bs h following smns: 16: This pr of h quion provids informion on wh concnrions would b obsrvd in pin for which h nurs forgo o urn off h drug supply. 17: This pr of h quion provids informion on how much h firs mx (fr h firs shor rm infusion) is wy from h sdy lvl of coninuous infusion using h sm o. 18: This pr qunifis how much highr h rough concnrions sdy s r comprd o h rough concnrion fr h firs dos. 9

10 Nm: onsidr h sm quion quion: onsidr: Numbr bwn 1 nd 0 mns h for im unis (T, or u) bing 0, h rlvn xprssing will b 1. Th xprssion will pproch 0 for lrg im uni vlus. Numbr bwn 0 nd 1 mns h for im unis (T, or u) bing 0, h rlvn xprssing will b 0. I will pproch 1 for lrg im uni vlus. Slc h pr of h quion (A,, or ) h bs h following smns: 19: This pr of h quion is numbr bwn 1 nd infiniy. 20: This pr of h quion is numbr bwn 0 nd 1. 21: This pr of h quion is numbr bwn 1 nd 0. 10

11 Nm: Qusion S VIII (8 ps) onsidr h following rlionship. 22: T F F snds for orl biovilbiliy 23: T F This rm indics h h highr h clrnc nd/or h smllr V of drug, h shorr will b h dosing inrvl ncssry o minin givn mx / min rio 24: T F This rlionship cn b usd o clcul h dosing inrvl for mulipl shorrm infusions if on dds h infusion im o h bov xprssion. 25: T F This rm should only b usd for drug fr orl dminisrion 11

12 Nm: Qusion S IX (12 poins) Qusion 26-31: Two pins rcivd lipophilic, unionizd drug, s n iv bolus injcion. Phrmcoinic nd physiologicl chrcrisics, such s dos, frcion of h drug unbound in plsm (fu) nd issu (fut), volum of plsm (Vp) nd volum of h issu wr (VTW) r shown blow. TABLE 1: INPUT PARAMETERS Pin 1 Pin 2 [mg] GFR (ml/min) Urin flow (ml/min) 1 1 fu fut Vp [L] 3 3 VTW [L] Indic which of h following prmrs (qusions 26-31) in pin 2 will b clrly lrgr (A), b ABOUT h sm (B), or will b clrly smllr () hn hos in Pin 1. Tbl 2: OUTPUT PARAMETERS Qusion: 26. (2 poins) Vd [L] of Pin 2 Lrgr (A), sm (B), Smllr () hn in Pin (2 poins) L [L/h] of Pin 2 Lrgr (A), sm (B), Smllr () hn in Pin (2 poins) 1/2 [h] of Pin 2 Lrgr (A), sm (B), Smllr () hn in Pin (2 poins) P [µg/ml] of Pin 2 Lrgr (A), sm (B), Smllr () hn in Pin (2 poins) AU [µg/ml*h] of Pin 2 Lrgr (A), sm (B), Smllr () hn in Pin (2 poins) Fr drug concnrion =0 [µg/ml] of Pin 2 Lrgr (A), sm (B), Smllr () hn in Pin 1 12

13 Nm: Qusion S X (5 poins) Qusion 32: Th following concnrion im profils wr obsrvd fr mulipl iv bolus injcions of drug. Th wo curvs diffr in on of h inpu prmrs (os, u, L or Vd). 100 INPUT OUTPUT 100 [mg] P(ss) u [h] Trough(ss) n r(ss) L pv(ss) Vd [1/h] Fluc. [%] F This lin blongs o h missing inpu d This lin blongs o h missing inpu d + Idnify h on inpu prmr h diffrs (qusion 32) A: os B: lrnc : Volum of disribuion : u E: non of h bov 13

14 Nm: Qusion S XI (5 ps) Qusion 33: Which of h following fcors migh significnly ffc(s) h rnl clrnc of hydrophilic bs (pk=7): 1. plsm proin binding. 2. civiy of cionic rnsporrs in h ubuli. 3. urin flow. 4. ph of urin. 5. GFR. A: 1, 2, 3, 5 B: 1, 2 : 1, 5 : 1, 3, 4, 5 E: non of h bov combinions 14

15 Nm: Qusion S XII (12 poins) Qusions Assum firs-ordr procsss. Mr whhr h following smns r ru (A) or fls (B). 34: T F A drug is limind hrough livr mbolism nd rnl clrnc. Th ovrll liminion r consn for his drug is 0.5 h -1. Th r consn for mbolism ( m ) is 0.1. This indics h 80% of h dos will b limind unmbolizd. 35: T F M Assum h drug is mbolizd. Th K of h mboli is 20 h -1 whil h of h prn drug is h -1. If h plsm concnrions 10 hours fr injcion of h prn drug r 1 µg/ml for h prn drug nd 0.5 µg/ml for h mboli, h plsm concnrions 13 hours fr injcion of h prn drug mus b 0.5 µg/ml for h prn drug nd undcbl for h mboli. (Assum firs-ordr inics for ll liminion procsss, lows concnrion msurbl wih h drug ssy is 0.01 µg/ml.) 36: T F For wo-comprmn modl drug, h volum of disribuion jus fr dminisrion of h drug is lrgr hn h obsrvd som im lr. 37: T F For wo comprmn body modl, lrnc nd volum of disribuion r lwys indpndn prmrs. 15

16 Nm: Qusion S XIII Qusions (9 poins) Slc h mos ppropri diffrnil quion for h following siuions. A givn diffrnil quion migh hv o b usd mor hn onc. Assum X is h moun of drug in h body (drug h hs bn bsorbd nd hs no y bn limind) nd A is h moun lf h bsorpion si. A: dx/d= - B: dx/d= - - *X : dx/d= *A - *X : dx/d= - E: non of h bov 38: A drug h is bsorbd nd limind hrough civ rnspor. Boh rnsporr sysms r surd. (Slc from A-E) 39: An immdi rls bl of drug bl o cross mmbrns sily nd limind hrough rnl filrion. (Slc from A-E) 40: A high xrcion drug givn s n iv bolus injcion showing linr phrmcoinics. (Slc from A-E) 16

17 Symbols Usful Phrmcoinic Equions = dos = dosing inrvl L = clrnc Vd = volum of disribuion = liminion r consn = bsorpion r consn F = frcion bsorbd (biovilbiliy) K 0 = infusion r T = durion of infusion = plsm concnrion Gnrl Eliminion r consn 1 ln L Vd 2 ln ln Hlf-lif Vd ln( 2) / L Inrvnous bolus Trough (mulipl dos) 0 min 1 Avrg concnrion (sdy s) pss L Orl dminisrion Plsm concnrion (singl dos) F Vd Tim of mximum concnrion (singl dos) ln mx Plsm concnrion (mulipl dos) F Vd 1 1 Iniil concnrion 0 Vd Plsm concnrion (singl dos) 0 Plsm concnrion (mulipl dos) 0 1 P (mulipl dos) 0 mx 1 Tim of mximum concnrion (mulipl dos) 1 ln 1 mx Avrg concnrion (sdy s) F L lrnc os F l AU l V d Equions/Usful_phrmcoinic_qu_5127 1

18 onsn r infusion Plsm concnrion (during infusion) 0 1 L Plsm concnrion (sdy s) 0 L lculd clrnc (hiou quion) 2 2 Vd L Shor-rm infusion P (singl dos) mx( 1) 1 LT T Trough (singl dos) T min( 1) mx( 1) P (mulipl dos) mx LT 1 1 T Trough (mulipl dos) lculd p mx mx wih mx * = msurd p, msurd im * fr h nd of h infusion lculd rough min min wih min * = msurd rough, msurd im * bfor h sr of h nx infusion lculd volum of disribuion Vd T [ mx 1 T T ( min )] lculd rcommndd dosing inrvl ln mx( dsird ) min( dsird ) T lculd rcommndd dos VT mx( dsird ) 1 1 T Two-omprmn-Body Modl T min mx lculd liminion r consn mx ln min wih * mx = msurd p nd * min = msurd rough, msurd ovr h im inrvl b Equions/Usful_phrmcoinic_qu_ AU / b / Vd Vd Vc r rinin lrnc L L cr cr ss ( 140 g) wigh ( ml) 72 p cr ( 140 g) wigh ( fml) 85 p cr Wih wigh in g, g in yrs, crinin plsm conc. in mg/dl nd L cr in ml/min

19 K for minoglycosids K = (rL) Mbolic nd Rnl lrnc E H = lin fub Q l fu H in b l H = E Q = H H QH lin fub Q l fu H in b F H = Q H Q H l in fu b l rn = RBFE = GFR in in ou l rn = l rn = l rn = r of xcrion plsm concnrion R of scrion - R of rbsorpion fu GFR Plsm concnrion Urin flow urin concnrion Plsm concnrion Idl Body Wigh Ml IBW = 50 g g for ch inch ovr 5f in high Fml IBW = 45.5 g g for ch inch ovr 5f in high Obs ABW = IBW + 0.4*(TBW-IBW) Volum of isribuion V V P V V P lrnc l os AU l V d V V T T K P fu fu T Equions/Usful_phrmcoinic_qu_5127 3

20 For On omprmn Body Modl If h dosing involvs h us of I.V. bolus dminisrion: For singl I.V. bolus dminisrion: 0 V 0 For mulipl I.V. bolus dminisrion: n 1 n( ) V 1 p: = 0; sdy s n rough: = mx ss 1 V ( 1 ) min ss mx ss If h dosing involvs h us of I.V. infusion: For singl shor-rm I.V. infusion: Sinc = for mx T 1 mx min VT mx ( T ) For mulipl shor-rm I.V. infusion sdy s: T 1 mx V T 1 min mx ( T ) Ls modifid 2010 :\urrn \ph5127_os_op_i\quions\ quions.doc

21 Ls modifid 2010 :\urrn \ph5127_os_op_i\quions\ quions.doc If h dosing involvs I.V. infusion (mor quions): T T V 1 (mos gnrl q.) during infusion = T so, T V 1 (during infusion) sdy s, -, 0 so, L V T V pss 0 0 (sdy s) rmmbring T 0 nd V L If h dosing involvs orl dminisrion: For singl orl dos: V F 1 ln mx For mulipl orl doss: V F ln mx

PHA Final Exam. Fall On my honor, I have neither given nor received unauthorized aid in doing this assignment. Name:

PHA Final Exam. Fall On my honor, I have neither given nor received unauthorized aid in doing this assignment. Name: Nm: PHA 5127 Finl Exm Fll 2011 On my honor, I hv nihr givn nor rcivd unuhorizd id in doing his ssignmn. Nm: Pls rnsfr h nswrs ono h bubbl sh. Th qusion numbr rfrs o h numbr on h bubbl sh. Pls fill in ll