ML20141J014

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Forwards Rough Draft of Regulatory Analysis for Patient Release Rulemaking
ML20141J014
Person / Time
Issue date: 05/31/1995
From: Mcguire S
NRC
To: Toohey R
OAK RIDGE ASSOCIATED UNIVERSITIES
Shared Package
ML20007J296 List: ... further results
References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-004, AE41-2-4, NUDOCS 9708140185
Download: ML20141J014 (15)
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UNITE 3 STATES g

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NUCLEAR REGULATORY COMMISSION

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wAssiwatow. o.c. soinoooi gg g,4 i

~ May 3i, i995' Co Dr. Richard Toohey ORISE l

P. O. Box 117 Oak Ridge, TN 378310117 -

Dear Dr. Toohey:

Enclosed is a rough draft of the Regulatory Analysis for the patient release rulemakirig.

Your work is presented in Appendix B and is discussed in section 4.2.3 on page 16.

Please make any comments you think appropriate.

v)

Note that we need the following in particular:

1.

For Table B 1, the doses for Tc-99m 'WBCs and TI 201, 2.

For Table B-3, we need a good cameraandy copy of your information and the references.

3.

For Table B-4, we need a good camera ready copy that includes Tc-99m' WBCs 7/

and TI-201.

Sincerely, Stephen A. McGuire

.(L q

97 81 185 970807 20 62FR4120 PDR 9%D'} b\\h5 NN j

OR PAC #! MILE AU 8ERVICES CAE RIDGE INSTITUTE POR CCIENCE AND EDUCATION Medical sciences Division RADIATION INTERNAL DOCE INFORMATION CENTER (RIDIC)

P.O. Box 117, Oak Ridge, TN 37831 0117 RIDIC FAX (615) 576 6671 VERIFY (615) 676 1053

.j 4f 30 "

S$.

THE RIDIC % % }k*? Rt.D

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i DATE June a, 1995 FROMs Mit hael 5tabin TEL NO I dl5 576 34 Q _,

70 s _Dr. S t yle McGtti re, NPO FAX NUMBERt _301 415 5305 vzRITY NOt This transmitt&1 CCnsirts of /2-pagese excluding cover sheet.

nemarks, J1. McSuf re - FM1bted are tT.P new 090PR f rom t he tir AA** mi l k dvr**M_-

P1 M ey Jet ina know it wu e+ed n_nv turther infermstion er if wu coed the__ inforetien in any ether.fs m.

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Co s:.tive tosivity :ne..t.a ar.a n.ai. ster no... E.e.tv.s

.I Isom the andsopn.rmAceut16e16 Cunstaer6d in this Report ss ttost.r Datterent Interrutt6t* Ger.vevian 4

Cumua6t9ve Activity Ef f ective D;>r Intet1upi. ice inmte E talent (cru JtiM pC ( _

[ ret *1rn 24 j;Y?-tid Co (1 Citrate. A(0) e S 9Ct, ein entaentration, t 1.bTf+C3 3

4.upt 02 6.178 01 2.11E+02 24 1.641+07 3.292 C1 1.Cyr*01 4.165.C1 40 S.198 03 1.1$E*01 3.84E+nt 1.47t+01 lf 7.14E.04 L.433 03 4.7(E+Ca 1.625e0C

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I23 S.51E C4 4.01E*03

1. C77 +C 0 A 425-D1 164 3.11E C6 4.Wst 64 3 075 0;

? tSE 01 3/A 3.065 00 4.1'tr 01 1.3'sB 04 f 4 3 E C'e Si2 9.2?B 11 1.W6telt 6.1'S 11 1 Aste;l l

Ge+CT citrate, klm e 5 m01, max concetta nLlon, to,.

l 3

1 9)F+0D 3.903 01 1.JJr+c4 0.CTEsD3 26 1.598+bu 3.*

'+01 1.068+t4 4.0CEt03 46 1.23E+0U

? *<

f.21h403 f.10C+C3 96 t,405 01

'a 4.933403 1,gtE+C3 120 9.73E*01 4

ber 3.023:03

) a6E+03 all

  • 44E*01 6

4 2.395+03 8,18t+17 4.43feC2 1, 41E + 'J 3 336 6 9eral 1

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til 1.61t a t 3 2; et 1.usF+ea 4.12560D 8

t mrt. min concer.ttat an, t'/d3E 01 Tf wvm DTtA, Atc)

. 29 a 295 C2 3.53R*01 1

3 2.t9E 03 Pd 3 430 05 a.7)**04 3.065.C3 1.358 03 46 1 10E.07 5.92a.07

' 45E C6 6.****0(

WE 1.6CE 12 1.404 41 3.02# 10 1,?%R*10 120 4.361 14 C.4CE.14 1.715 12 1.tyt 11 1(8 fi ODE +0C C 0CE+00 0.00E+00 0.0CE400 33C 0.tus+Dh 0.00ti?0 0 60E*00 0.00E+0C s

672 0.00k+V) 0.0bi+00 0.uCF+00 0.C0rt00

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20 N*t.maxconcentratsor.,t,d*i g

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Tc Wyt tTPA, A(0)

J 4.76f-03 2.3FK.01 6.02D400 1.

E+C0 24 2.61E-03 1.315 43 3.29E 01 1.4Sa*Ci if 9 All-C$

4,728 04 1.19E=01

$. 24 E 'J 4 PG t. '. J k a O7 6.14E 07 a 995 CS 6.828 04 l

i 123 4.43r 09 2,22; 08 5.$W>+C7 2.4CU 07 4

166 5.77t*12 2.475 11

0. 0 0 E.+ 00 0.0C&+00 0,00E+JL 0.0CE+C0 1

W17 0.008400 0 afE*C0 0.C0E+00 h.00E+C0 t

Tc 69m MAA.

A(0) e 4 mCt, min conter.tratien, tyji 3

6 4FK+C3 1.(GE 01 4.195+C0

. 10T+ 00 24 3. h 'J 8 - 09 9.005 04

> 265 02 0.19E.c4 i

48 0.21B*u8 2.31E C6 6.83u 05 2.3CE C5 96 C.01E 13 6.53E 11 3.82E 10 1.553 30 a2C 1.$4E 15 A h%3 14 9.69C 14 1.338 13 169 0.0CE+00 0.CpW+00 0,0CC600 0.c0E+0C 334 u,0CE+C0 0,COE*uu D.0DE+00 0.00A403 672 0 065e00 C.CCE+us 0.03B+00 0.0ck+CD e

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M/DS#95 14100 iC.700 P05 Table L (cont'd)

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Cun51stive activity thgested and flodistien posen Raueived f rom the Stadic$netweetticals Conridered in tais Rep >4 6 l

Under Dattetent Mt et s.@ tion Cet.edu es Cumuistive Acttvity Effective Eott rm tut 7Ing2*[ed

.amdyntd ~1 Interrupttrm ta m en Ff.Enna 3 'rdL1d i

Tc 99es WA.

f Ull e 4 mC1, men conctattat fY1. Qt 3

4.'186 01 1.19D401 3.01402

. 22E402 24 3.01k.0) 7.66E*01 1.61E+C1 7.8tt+02 48 1,338.GJ 1.33E*02 0.38E-01 4 4CE 01 96 3.518 06 6,28E 06 1.50D 03 6. 4 4 R f.4 j

120 1.095 07 y 14E'C6 6.005 05 2.166 CS W8 2.065-10 5.14b*09 1.19E*07 1.2$E-vu l

3A6 0.C03+00 0.001490 0.0CE+00 0.00E+00 672 0 n0E+00 0.00E+0c 0 nrE+C0 0.003 00

)n i<1. trin concentration, f gfp Tc.)lm C4, M 0) 3 1.985 02 1.$9E*01 1.058t01 F.07E+C0 24 2.5LE 04 W 61E.06 1.CSD 01 4.sts 02 48 6.638 07 2.21k C6 2.705 04 1.25k.04 wh 4.368*11 1.458-11 1.17E*03 0.238 1C 12V 1.11Ea14 3.69E.14 4 9CE.12 2.0PE.12 e

165 0 0CE+00 0.00E+00 0 00E+C0 0.003400 336 9 ers+CD 0.C0E 40 0.unn+C0 0.COE+00 C72 0.0V6+00 0.COE+00 0.005 00 C.0CE+C0 e 30 act, min concentration, t,p Tr'+99m 04 A(0) 3 3

2.C3:+DC S cip+ r 0 8.25:+02 1 8 J # es2 24 1.44E 01 t.81h.04 54880+01 3.73E+01

&b 7.0SE*03 2.355 02 2.67E*C0 1.33Ei00 96 l ate *CL 5.61E 05 6.84E*C3 3.17E 03 120 8 /tE C7 2.74E 06 J.J45 64 1.553 04 168 1.966 09 6.535 03 7.97s*01 3.6)E 07 336 0.00E+u0 0.0CE+C0 0.COE4au n.0CE+C0

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672 0.C0E+0V 4.00E+C0 C.CCI+00 0.00s+DC 1.in Net, MC) 150 e"1, min co woutration, tkf,11E+0s e

i 1,0(E+CD 7.073 01 6.28E+CL 24 1.4*E 01 D. 6 6 E. 01' 8 985+04 6.14E+C4 48 1 495 02 9.94B 03 s.43R+03 C.02EiC3 SG 1.588+04 1.0CE 04 9.JJE+31 7. 0(.E + 01 120 1.62Eeub 1.08E C5 9,602400 1.20E*00

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168 1.71E 07 1 't45 07 1.03E 01

^1.618 02 346 1.920 11 1.25W-14 1.14E 00 8.54a 09 i

vi) 0.0CE+C0 0.00E+00 0.00E+00 C.00E40J 9

1 131 Na!, ALO) s 450 mC1, max concentration, CY.I)3E+07 3

7.5DE+>l 5.0CEt01 4.44W+07 24 7.50E+01

% 00E+0i 4.14E+01 1.333,07 48 7.50E+01 5.n0E+01 4.44C+07 4.13E+07 96 7.105i01

5. tut +01 4.44C+07 J.33=+n7 110 7.LCc+C1
5. Con +nt 4.44E+C7 2.3Js+07 16B
7. SCI +C1

$.00E+01 4.44E+07 3.33E+ur 335 1 MAI+01 1.253401 1.11m+07 04J4E>C6 i

672

?.6st*01 5.12C C1 4.b68+n9 3.41EtC5 i

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DOS 14iCG p(),7Cg 903 i

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~~N Table 9 (rnnt ' d)

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Oumulative Activity In96sted anc. spotarien Coses Revelved

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lave 4he Radtorharmaceuticals Consideree in this Espos; Under Different Interruptien seneaules Cutaulative Activity Eff*etive Pose Ir.t er rupt ien inaented tauivalett (tre*$

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J mC1. min soncer.tratien, t y$2 04 l

Cr 51 EDTA.

A'UJ e

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y A.545 r2 6.655-04 3..

3 7.71E.06 If D itt 07 1.uws 03 1 otE 04 4.04E-0!

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to 9.!SD 08 1.415 04 9 61E 06 4.11E*06 96 7.02E 10 1.40E 06 0.06E.UW 1.3BE-06 Ito 6.17E.11 1.27D 07 7.3CE C9 3. t4 < a 9 168

  • 24E 13 1.C58 09 G.CCE 11 2.51E.11 336 1 56w ?n 3.12E 17 1.?fs 19 7.fCE 19 672 0.puhetu 0.00E+00 0.0LE+t0 0.00E+00 m,1, mov noucouLietion, tqr'E.C3 Cr 01 SDTA, AtC)

.us 4.75E.C2 4.h75 03 1.83 3

3.37E 0$

24 4.13E 06 0.36E 03 a san.04 1,ptE C4 g

46 3.74E 07 7.4CE Ct 4.2pr ut a.4nr.rA

$6 3.C98 0) 6.ltE CG 3.83E 07 1.48E 07 120 2.S ht 10 5.572 07 3.1DD 08 1.34h us 160 2.2vt.AS

  • .485 09 2.02C 10 1,10E.10 33C 6.82E.29 1.165 16 7.82E il 3.28E-19 671 0.0CEiOD 0.00E+0c 0 Dtt+C0 0.CCE+00 Te-ywm 01F1DA, A(0) s 4 mCL, min conc 6r.tratten, t A

4.64E-C3 7.CSE 02 4.40E+0C 2.Edka03 24 A. sis-r4 1.465 03 9.955 02 4.76E 02 49 1.Jtt tA 1.74E-05 1.10D 03 6.69E 04

$6 1.9/m Ac 9,475-09 1.C02-07

4. ole.C0 f

110 2.352-12 V war 11 2.C0E 09 f.57E 10 100 3.21E 16 4.02R 1%

2.13E.13 1.31E-13 336 0.COE400 0.DCE4GO 0 f'OR*03 0.00E+0C

-~s

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672 0.CCE+00 0.00E400 0.00*'o$

0.00B+0C i

mC A. max cor.esntratten, t,9te nu

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Tc kvm D15tDh, AfDb = 8 2.02E 01 1.D:E+C1 9.1 J

2 19R C2 24 4.596-u4 5.C9E-02 3.878+00 1.65E+0p 48 7.32E.C4 9 154 03 6.23E.01 2.00D 01 96 1.69E CS 2.36E.04 A 615-02 7.7CE C3 120 3.04E-06 3.CCE 05 3 byk 0J 1.24E 03 I

168 7.86E-06

$,C30 07 6.695-Ub 1 20E CS ds6 2 1 AE 13 2.73E 12 1.0$E 10 6.W9k LA 672 u OnR+00 0.0CE+C0 0.COE400

0. 00E + 0ti mC1 min evuwentre len, t.'1E+0C Te DPm gluco, A(0) 2n 7.41h 02
7. ACE +C0 0.3 3

1.40E-02 24 2.01E 04 1.315 0J e 06R C2 9.48E 02

  • A 2.59E 06 1.295-05 4.u28.ca 9.365 04 96 2.53E.10 1.2?3 09 3.94E-C8 9.19E 06 12J 2 $1F.12
.255 11 3.9DE-10 9.10W.10 16B 2.21E.16 4.11E 15 3.44E 14 8.03E 14 33C 3.0DE+00 0.ot*+03 0.00E400 0.0C5400 e

672 0.00E400 C.00:403 n ent.00 0.0CE+00 e

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Table $ temnt' d) t

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Camolative A?tavaty InAested ana v6n'atlop Dosco Reestvad (som enc Radioprarmacwaticals Con 616eved in tt.se Report s

Under titterent Intesruptict schmiule s Camalative Act1Vity Offcetive DnSe Ir.terruption in4Cated

,hutulgt ;mr C e

l Ilm2 lbL1

_ -fi f rnct L?n EExLag n

& Jr-old trette gluco, A(0) e 20 m0L e4x con?*ntamLion. 1.IdE+01 t i i

3 3.02C-UJ 1.51E 01 4.rtt+C0 24 7.955 te 3.995-03 1.74t+01 2.105 01 i

46 1.255 0s f.37E 05 1.DAu+03 4.350103 96 3.103 0E 1.3!I 03 t.Ita.n1 1.1:E C6 att 4.07E 11 2.433 10 7,56E up 1.70c 00 168 1.195 14 t.W7A*14 1.86E.14 4.338 12 l

336 0.3CreC0 0.00t+nc

0. 0C t +C0 0.005,00 672 0.00E+00 C.COs+0h 0.13Ci00 C nCE+00 t

mCL sin cor.tentratlan, t,"d.i

. A Ta* 9pm 1901

/. i v) 4.505 01 2.90R+01 13E+0L 3

2.(CE 0/

24

.43E-04 3.54E 02
1. 5 'i d
  • c 1 6.053 02 46 1.11C C6 4.39t 05 5.175-04 2.510 01

$4 1.723*11 2.146 10 9.52f 09 4.87f C) 1:0 6.143 14 f,12k 43 3.74D 11 1 %25 11 1

1$2 U.00Ee00 0.00B+C0 C,0CE*0) 0.UJE+0C 33C

0. urn +00 0.00E+00 C.0CE+C0 0.cos.oe 67:
0. 0C E +t-a 0.00B+00 0.0nr+00 0.00E*UO 9 201 mer, concentrattom, (pd.i01E+01 Tc.99r hhM.

A(0) 3 8.ifE 0:

1.1)R+C0 4.97E401 24 1 12E 08 1.4Wm n1 C.21Ee00 2.53E.00 46 s iet 03 1.30E 7) 5.77E 01 2.45t.01 DE 6 tAE C6 1.12E 04 4.96E 03 2.viR+03 120 9.3tk*07 1.04C 05 4,635 04 1 vet 04 148 7.218-99 f.01E Cl 4.005 06 1.C2E 06 3)(

3.C0E 16 4.755 16 1.6sr.13 C 7sE.14 612 C.0CE+CV

h. COB +00 0.0CD+00 0.C03600

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Tc )$m NAht.

A(0) a 30 et.'t. mia concentration, to/J7E C1 8'--

3 2.23E 03 7.44k 03 1.16E 00 24 k.835-05 2.94h ce 4.5?D 02

> 12E*02 46 2 2CE-06 7.3?E 06 1.14E 03 6.fut-04 t

36 1.3'tk.09 4.5CE 09 7.095.C7 3.:9E 07 120 3.412-14 1.14B 10 1.7/ke00 9.21E 0v Avn 2.122-14 7.0tt 14 1.10k-11 S.11C 12 JA6 0.000t00 0,00Ee00, 0.00E+00 0.00E+00 672 C.00E+00 0.0-sk+0C C.0CE +C0 0.CDE+0C m:1, mox innutotrotton, t,Y3E*00 i

Tv 99m M2B!, AfD) s )C 3

1.Pah.0)

(.$CE CD 1 02E+D1 4.

24 2.;4E.U4 7.47E C3 1.166+00 3.30f 01 48 1.C7E-04 A.24N 04 9.7CR t2 4.513 02 94 1.31E C6 4.163-06 f 77E L4 3.14D 04 120 1.05C 07 3 64E-07 3.6(E.Ub 2.(3D 05 140 7.61E-1C 0.54k+09 3.$5E 37 12435 C7 336 0.005,00 0.DCE*to 0.003 00 0 00E+00 671 C.uct+00 0.00E4VU C.00E+00 0.033,00 f

A 4

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i Table $ teent'dl

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Cunaiative Activity 2ngested m.d Kadiattor. Ioa s Fersived f rom the Pe<iterwn.aceptscals ermeidered 1p tain upert

(\\s_./

Under Different inttrruption Cchedules o

Cumulerise 14tivity affective Pope Interrupt ion

, k nemtig aNivalent _inqds Tire ttu mC1 _

inuaan I!1gh,Cs 1 fr-

, min concentration. &f.#$? tic 0 23 mC'.475 02 3.64E4au Tc 992 MD0 A(C) 4 3

A.945 D) at i 40E 04 7.0/s*f4 3 71E*04 8.16E 02 42 4.125 C; 6.0Wa*06

4. DIE *C6 1.492 04 96 9 Aft 11 4.fWa*10 3.73E*t's 1.42: 09 120 7.W48 13 2 97E.F 3.238 10 1.23E*10 166

(.15sett 2.08E 16 1.69: il 6.458 15 t

416 C.00E+u3 0.00E400 0.0CB+00 3.UJE+3C 673 0,0CE+CU 0.COF+00 0 DCE+C0 0.006+06 Te 9)m MCP, Af01 20 et1 max cenecntrat nu, typ i

3 4.20E*01 5.v68 02 4.87E+U9 1.0fE*00 at H.32E*04 3.464 d3 2.82E.c3 1.CSE D1 40 2.67t=CS 1.33s*od 1.09E 02 4.148-03

$6 3.965 06 1.50E 07 1.611 D$

6 19E C6 120 1.62k 74 7.G22 09 8.20E 07 2.178 07 JMA 2.065 12 1,13E*11 P 70E.1D 3.b1R-1C JJ6 0.3CE+03 0.C02 0C 0.00P+0 0.CCE4uu 672 0.00E+C0 U.00Es00 0.UJushC 0.QCE+03 Tc pha PYP, A(W s 20 FC1, mir concentratice, C,Ir l

3 1.'<JR 02

0. 6 6 F 0*>

4.61E+00 kG4E+00 24 3.7Vk f4 1.36E 03 7,$$E C2 4.122 02 44 1.365-06 1.38E 05 6 44E.04 2.19FaC4

{

96 1.778 10 6.67E.10 4 42E*06 2.10k+C8 120 1.040 12 7.7?E 12 4.77E 13 1.927 10 168 8.0GE.17 4 02E*1C 2.23k+14 9.53E*16 336 n,0CE+C0 U.COE+00 0,002*00 C.0cteca GT2 6 00E+00 C.0tw400 0.00E+0V 0.0CutCO

'N

\\

te tem Pyt, A(Os e 20 m:1, max enneentratton. t,,gs 3

6.73F 02 4.073 01 2.42E+C1 1 03E+01 26 1.03E V2 S,14E 02 2.85B+00 1 /2E+C3 4M 8.003-04 4.45E.C3 247E 01 1.3th e4 P6 6,6BC 05 3 445 C5 1.655-0) 7.91E*08 120 5 795 07 2.9a4 06 1.615 L4 6.06E 06 160 4.3%E*C9 2.1?x-06 1.21E 06 S.1LD 07 336 4.20N 17 2.1CE 16 1.173 14 4.97E 15 672 0.00R+00 0.00E+C0 C.00E+00 0.005 00 Tc 0Pm k3C vivo. A(0) e 20 mci, min cor.cer.tratten. t Ed1 3

9.40E-04 4.753 03

? AnE 01 1.3tt f

24 1 123 04

% $85-C4 3.JWr-02 1.618-(2 19 4.67E 06 4.848 05 2.94k.0%

1.32E 03 DG

's 265-09 3.64r-$7 2.2CF-05 P.94E 06 1:0 6.J4E C9 3.152 06 1.217-04 8.622 07 168 4.73k-18 2.36E lu 1.43D 09 e.47E 09 J46 4.57E-19 1.28E la 1,398 10 6.2sF 17 67s C.DCDiCD 0.00E+00 0 nr.S+0D 0.C04430 r

r k

4 1

/

i Q

l l

i r

bkOG45 14101 IO.700 909 Tablo 5 (cent'ai

/

\\

Camalative Aet'vity In;ested and Faoiativo Dossa haceiven

\\s _, /

h om tho Radleptarmsveatica's Conside'ad in this Report Under Eiff **m:a interruption lehndules s

Camulative Artis;ty Effsetava pose Interry t109 I(Lqistef

,EJuavalent W end

_l tr ut ic"1 linbqn i. t r oM

-e JM (br:

tua))m P.50 vive, s(0) e 2C m01, mawc.ourentrattor.,t'Y1 3

4.38E 01 2.19D+00 a 11E+02 6.961+

24 5.4tE 02 2.743,01 1.6(L+Ca 7.00D600 an 0.002 03 7.b(1 03 1.545 u0 6.tCE 01 fa 4.303-05 2.20E.04 1.332 02 4.01E C3 140 4 C0g 0(

's ueE C5 1.*4E 04

9. Sit 04 168 3.522 00 1.68 n?

1.07E 05 4.812-0C 336 1.47E*15 7.3Jael9 4.45E 13 2.025-13 672 0 DOE +C0 0.Cos+0a 0.005100 0 0CE+00 20 mC1 min concettrction, t4.03Rhf.

Tc*99m REO vitro. A(C)

=

3 2.f3E-04 1.765 02 1.JOR+00 24 6.46E 04 2.735-03 1./0R ci 7.4TE 02 46 6.47E C6 L248 04 0.01E r2 8.CCE 03 96 9,10E 07 4.5%E 06 2.91E-04 1,2SE 04 y

lic 1.CBE-07 6.JtR 07 3.35E 0$

1.4tE*C3 160 1.!2E 09 7.569 8.9 4.71: 07

2. NAE 07 33(

4 49E 16 2.44E 15 1.S4E 13 6.'164-14 67%

0.0tw+00 0.003:00 0 60E+C0

0. coa +no Te Wwm PE: vit ro, A H4 = 20 mC1, wax cont:entration, t.[:

1 6.CCE 03 1.03E C2 1.48E+0n 6.30E 7 24 1.1C: OJ 6.01E 03 3.74E 0) 1.65E-01 45 1.9CE 04 9.40k 34 S.90D C2 7 99E*01 96 d.70E-CC 2.35r 09 1.4CE 03 6 445 04 120 7.AIE 07 3.71E 06 2.30E 04 1.0lF 04 1

160 1.84W 08

9. CE C#

S 725*00 2.525 t 6 f

33(

4.432 14 2.22E 13 1.345 11 6.07E 17

/'~~'K 672 C.0CE+0a 0.COE+00 0.Utt+C0 0.C0E*00

\\~-

  • c ppm se, A(Di = 13 n41. ein yuneentration, rgY, %75 +C 0 i

3 1.265 02 1.0?k 01 9.333100 D4

't 36E 04 C.*Sk 0) 5,4CD 01 2 685 01 46

'J hes CS 2.40E V4 2.225 03 1.0%E-02 96 4.4Ue' r 8 3.672-07 1.261 C5 1.6n< 05 120 1.72h 09 1.43D 00 1 27E*06 6.23E t' iF8 2.C2E 12 2.15C 11 1.943 03 9.515 10 3)F 0.00E+00 0.00E+00 0.00E403 0.00E+00 6 1 C.00E:00 0 035 0C C.0CE+c3 0.00C400 Te-Sym EO, A(3) s 12 rC1,taxcenteatration,t,[.ANs+C1 3

1.'t4R 01 1.$7E+0J 1.30E+02 24 3 0ba nf 2.J4E=C1

/.26E+01 1.11k+0i 48 4.11E U$

3.425 02 3.04E+C0 1.49E+e0 46 7.47E 05 6.225 04 6.5Jher2 2.715-0*J 120 1.01E 05 F 49E*05 7.45E-u) 3.(SD 03 1,9 1.833 07 1 TJE*04 1.355 04 A.64E C5 3)C 485-13 1.23E 12 1.09; 10 5.4EE 11 673 C 00R+00 0.00E+0c C.0CE+00 0.und+0C o

I i

l r

-___a

()

i I

b909/f5 14102 NO.700 D10

+

t t

[N Tcble i te09t ' d)

}

/

/

Camulative A?ttvity I4,pested ans Fao9attua Doses Receives

\\s,_,/

facm the Es$1cptat1 mace # aca.s Considered in thse ncpen-t Un$cr C.iterest Ir.terruption Web >dulto Camalative Activity Et(ective Dosa It.t et rupt icn Instoni

.E rivoltal d it h

  • 1 tagM b.m.ptas n 1.n M

. Time (tgi 16 111 WEO, AIDI e

.S mci, min eencen* ration, ggge 3

C.21E-04 1.243 01 3.V4R+C1 U.0tE+00 24 S.23E V4 1.CSE 01 1.72E+t 4 6.17E+00 en 4.3CE 04 a.40E 08

1. 41 R +'ti 9 37E+00 en E 01E 04 m.42E*01 9.54E+0L 9.77E+C0 42n 2.32D 04 4 ~rAE C2 7 C0Ee00 1.1C&+C0 148 1.42E 04 3.24h*e2

$.323:03 2.n%I,0C 3)(

4.11E*0$

9,225 JJ 1.)tt+C0 6.3/n.01 (72 2 6et C6 5.31E ve 8.'$t C2 3.44ka02 4 mCs, r.ax concentrativu, t I.2;3g,93 an-111 WPO. A(0) g 3

3.10E*03 6.195 01 1.C2E+va 24 2.79E 03 9.565 01 0.19Eevi 1.61S+01 en 2.405 03 4.8%E*31 0.16E+01 3.21B+01 9A 1.) E C3 3.9/R 01 C.43E+01 2.53Ee01 120 1.738-03 3. 41 r' 01 3.71E*01 v.29E+01 itt 1.3 3 03 2.74E ut 4.50E+01 1.71F401 3)(

4.tBE*04 1.1GE da 1.963+01

'.1AR+DC C72 1.1tE 04 2.2GE 02

  • 72E+C0 1.46s+3e
  • C4, w.in eencentrat.1vo, tgT.i t 123 No:, Ato)

=

6 2.58E+00 E.11t+nt 2CE+ca L

3 1.03E 02 se 6.433 04 2.118 01 E 001400 3.44E+00 40 4,845 05 1,215 H) 2.67E 01 1.p'n*31 i

96 1 %95 07 3.98E-0$

9.42E C4 6.46E 04 120 9.12w 09 2.200 06 p e0E 05 3.71E-05 I

lie 3.03E 11 1.49E 0)

1. MR-07 1.22E-C7 06 0,005 00 n.DCE+C0 0.00r+n6
0. 00E *C0 t

/'~'\\

672 0.CCEi00 n.bCE+00 0.00E+uq 0.00E+00 i

\\

2 123 FaA, A(C) =

.4 mCL, max concentration, t9p 3

1.08E 02 2.ior*00 6.40B+01 4 4cE+01 l

24 M.86E 04 2.225.u1 S.23E+00 J.61F+C0 46 5.rAE-05

1. 27 E. C'J 1.015-01 2.01t-01 96 1.416 n7 4.17E 05

$ AAE 04 G. 7 pE :;a 120 0.66E UW 2.393 06 6.66k+CS 3.0DD 01 int 3.14E 11 1.25E 09 1.869 07 1.100 0' 4A6 3.00E:00 0 oCE+03 3.00E+0u

n. 0C E+C D 573 0.00B+00 0.0th+03 0.003:00 0 00E+00 roc 1, min concentration, tU2'. (2E+ no 1 123 CIH, AtC) e 1

3 1.63s 02 0.13D 01 3 A*Ett0 24 2.50E te 1.30E 02 E.3hn 02 2.6CE 03 48 2.31E.96 1.1!E 04 5.47K-04 2.312 C4 96 1.82E-10 9.06E C) 4.30E-06 1.07E 09 an 1 C18 12 U.04E-11 3.42E 10 1.615 1C 166 8.795 17 1,4st 19 2.0CE 14 m.7aE-15 32(

9.008+C0 0.COE*u0 0.00E+00 C.out+03 672 0.00R+0C 0.00E+0a 0.CDE+0C C 0( * +00 4

A mm.m.

e

  • m*.

/

\\s i..

D6/08/95 14:02 to. ';'ac pit s

Talle 5 (cont'o)

/

g\\s_,f Cumulat6ve 34tivity Invented and Anstatten hnnes Received (som the hat.tophermaceutiento Constderes to this Report Under D$tterent Intetruption Echoeu9en comulative A-fivity Cffective Doam intarruption

_Intesley J ulyftl er.t & rem Time thr) ml

_f re et iot utthstr.

1 Yr old a

I mci, max concentrat tur., tg4$.245101 2

1 123 CIM, A(0)

=

6.185 00 L v3*+01 3

1.44k 01 to 9.let l) 4.93E 01 2.23E+30 f.45E 01 46

$.445 94 2.145 C2 1.30E 01 S.47t+C2 96 1.(95-06

> eBI CS 4.COE 04 6 698 04 J26 P.303 09 4 tva 06 2.120 08 v.3'**06 166 2.ftE 10 1.455-96 6.8tE CD 2.Wps+SA 336 0.0CE+C0 0.CDE+DC h DCE+00 0.002400 C12 0.00s+f0 C.003:00 0.065*00 C.0CE400 e

= to mC1, min eencontration, Lugi l

1 128 m100 Ato) 3

$.412-07 5.41E*C1 3.20E+03 I.20E+02 24 1.51E 02 1.315 01 8 PCE+0*

6.165+01 et 3.533 C3 J.Stt-02 2.06E401 1.44E+01 v6 1.72E C4 1.92t-03 1.14t*C0 1 625 01 120 4.46E C$

4.4Wuene 2.653 01 1.57keC1 14W 2.44E-06 2.44E 0%

1.445 02 9.9sh*C1 236 p.153 11 9.158 10 S.42E 07 3.735 u!

C12 C.eus400 0.00E400 c.00R+00 0.COE+00 10 nci. mas concentratinn, L./.2CEt02 I

e s 123 m3b3, A(0) 3 3.41E C2 5 41E 01 3.20E+02 24 1.$15 02 1.b1R 01 8.CEEiD1 6 LEEtC1 du 3.535 03 3.53E 02 2.C95+01 1 44e+61 76 1.92E 04 1.92E US 1.14E+00 7.02n*01 12D 4 ARE OS 4.40E*04 2 49E C1 1.825 DA 3C0 2.44W 06 2.443 05 1.44P 02

9. 2E-03

$36 0.15E 11 9.1SE 10 5.42m 07 3.73D C7

/'~'g 673 0.00E+00 0 OCE+00 0.COE.00 0.0CE+C0

/

.01 mC1. Fin concoatration, tug 3 125 UAn.

4(0) 7 2.52E 04 2.52E+00 2.24E 01 p.C4E 0?

24 1 20E 05 1.208 01 6 07E C2 4.31E u3 45 3.Tek C7 3.75: 03 d.30F+C4 1.332 04 96 3.558 au 1.35E 06 3.ima+07 1.27C 07 120 1.10E 11 I;1CE 09 9.755 09 3.94E C9 sen 1.058-14 J 095 10 9.32E 12 1.77E-12 1

J38 0.C02:00 0,Duk+00 0.000603 9.00E,00 6 12 C,0Cc+00 D. CON +3C 0.0CE+00 0.0nR+00 j

f I 125 OIW, ain) s

.01 cci, max ecc.cnntration, t ni i

3 2.>3t 04 2,52E600 2 24E-01 7.'04E C2 24 1.20E 06 1.2CE.C1 1.01w 02 4.31E 03 l

j es 3.12E 07 1.711-03 3.3CE 04 1.338-04 97 2,55E 10 4.95E 06 3.18 E C7 1 273 D' s

123 1.1CE li 1.1on 07 9.?$E CP J.94E 09 168 1.035-14 1.05E 10 9.32E 12 3.77F 12

(

335 3.03E+00 0,0CE+C0 0.0DE+0C 0.00E+co g

C12 U.V0F+00 0.0CEtCD 0.00Et03 0.00F+00 t

R h

9-N tk

1 e

Terle $ Nent'dl m.

Cum 91st ava kJ +vity Ingesta <1 and AA6sation Dwees Faceived

\\

I f ror. the d4diopharmaceuticals Consiotted in this Report

\\s~,

vn3*t Dettercnt actatauptien seteaules E!! active 09sa Cumetative Activity

.fribalent irrt!.L Int errupt ion fe m ted,

1 Yr-0)$

Jiro thrt m0 L

!.1EaMo lerta n s

mC1, mir concentrattor, tp[i t.131 01H, Al'n e

.3 3

2.6tu.03 3.736 01 2.01E400

.16E+00 24 3.365 66 1.098 03 3.615 03 i.453*03 48 1.56E 09 3.1SE*D7 1.73E CC 6 915 07 96 3.40E.ih 1.163 13 1.865 13 1 %4E 13 410 0.005 00 0.003400 0.00t+00 0.08:400 1&W 0.003:00 n,00E+C0 e, r,r.E+ 0D 0.0Dh*0C 336 0.0CE*00 0 005 00

0. '>t u+ C 0 0.00t+00 (13 6.0(E+C0 0.00E*00 0.0Dk+CD 0.00E+ua A*lti 01%, A(UI e

.3 m 1, mat toisentrat60n,t.Y.:655 00 3

1.50**01 4.975+u0 1.CCE601 26 1.23k 03 4.C0E 02 1.3(8tC0

%.4$E.01 48 7.051.v5 2.35E 02 1.025 03 f.13E 02 9E 2.325-07 7.73E 06 7.263 04 1.ukt.c4 120 1.33: 06 6.44E-CC 1 48E.05 5.91k+Se ill 4.385 11 1.465-Dt 4. W 6 F r,$

1.95K 6A 338 S 00E+C0 0 (0E+00 0.Out+60 0.0CF+0a C12 0.uD5+0C C.Veren0 0.00E400 0.0CE+C0 e

u.01. man coneAntiation, t y,4. J tt+ C2 i

= 3 I'

T1 201 C1.

A(0}

)

1.2tV*u2 1.00C 01 4.965+D2 We 7.4D3 0) 2.50$ 01 J.C95+02 1.WA*+02 4v 4.$25 03 4.648 01 3.QCF.+C) 1.265+02 i

96 1.458 C3 U.JT2 02 P.9 5+01 6.26E401 120 1 761-03 6.66F 02 7.16E+01 4.4931C1 166 9.10g $4 3.Olk.07 3,70t+01 3.32t+01 1

j

136 0.11w n%

3.0tE.03 3.71E*00 2 13S+3C e

5 6 12 S.13E U#

3.C48 05 4.722-0) 2.11E 01

(

mas concer.tretiv.1, e 3 met, n s 05k+02 11 301 ci, Ain) 3 3.312 D3 i 91E 01 9Jnt+02 29 1.66E 02 6.218 01 7.tik+C2 4.76E+ut 46 1.518 02

5. tar-01 C.1(E602 3.0CE*0W

$6 1.16R 32 3.00E 01 4.74B:33 2.9784C2 12C 1.01s n2 3.865-Ci 4,30:402 1.73E+02 14A 0.11E Ud 3.14E 01 1.83E+C2 2 405 02 WJ5 C.71E C3 2.24E 01 2.13I,02 1.118+02 672 3.S3E 03 J taE 01 1.46t+02 9 01k4C1 mci, min concert ration, t i

+

rn sha DTrA Aer, A(0) 1 3

$.leF C$

E.14E-04 1,4 0E t*J 6,00 03 74 4.97h 07 4.81E.05 1.353 04 m itE-C5 4A 2.378 04 2.37E C7 6.!*s 07

? ADS *07 9e 5.60E 14 S.60s 12 1.53E 11 4 635-12 129 2.72G.16 2.72E 14 7.i!E 14 3.7JE 14 160 0.00B+C0 0 00gt00 0.038+0C C.DCE+no 336 n.CDE*00 0 OCE+C0

0. tnt +00 0.00h400 G70 n.00E,00 0.0aW+0C 0.DCE+03 0.007 00

~

k k

m

h.UOU95 14103 m,700 p33

~

Table $ (cont'd)

Cumulative Ac 1vity in?*mted and Fed 14tlon Dctes lacelied

\\

/

}

fron. the wadite.harmse*utir alm Cor.steera$ la thic FepSt t i\\s_,/

Dif f erent tet e4raption Ser.edvies Vroet Effective tvoe Cumulattve Act1vity Agivelent itti g4),U tdt e tTitM iOf}

Ing(

n.II 0 litte M Ti

+rAElisa Emout t

Te Dim DipA Agr, At0) = 1 mC1. war concentratten,1.1tI. p ;1 3

9.93c 01 0.33E 02 2 iet 01 0

24

?.43E 05 6 43E 03 1.618 C2 6.44E 03 40 4.96E*06

1. NEE 04 6.44a-64 2.32E 04 96 2.%41 09 2.56g c?
7. Cpg.37 3.025 tes 12C 9.2:n 11 7.315 09 2.56E 05 1.099 de 166 1.20E A3 1.20E 11 3.32E 11 1.42E-11 3JA 3.00E+0V C 0CE*00
0. 007.+ 3 C 0 GCE*C0 672 0.C05 00 0.0(C4C0 4.COE*00 D.00t+00
  • t:1, min ocncentimLion, t'.Y6F C2 t

10 3

1.291 03 1.19t+02 1.b2R 01 6

tr.its KA43, AfD) 34 1.225 00 1.22E C4 1.44k.03 C.308 04 40 1.v2R 06

$.9/F 07 740CI t's 3.C6E.96

$6

1. 4t s'- 12 1.402 16 1.C(I lu 7.2EE 11 12h C.Sch l%

C.CCE.14

6. C
  • D '11 1.52C 13 f

its

0. Cat +00 0.0CEfC0 C.C0!*00 h.00E+0C 336 C,0CE+00 0.00s+00 0 DCt+00 0 r0g+0C 692 0.0CE+00 o e0E+00 v.h0E+C0 0 Out+0D t gp(si. d 2 + 'JC maA CDnt entt' AC 10.i, TN 99m MA'J3, Atd a 10 W.' t.

3 2 4bR 03 3.377 01 3.83E+tn 24 1.31d.03 1.312 02 1.S$5 01 C.77E 02 44 4.12E-0%

4.72E 04 S.LSD.03 1.443 C3 9A G.16E-nh 6.145 C7 7.27D 06 1.168-06 120 2.22E 0d 2.22E.00 3,629 C7 4.155 01 168 2.898-13 2.89 11 4.423 10 1 *CE.10 036 0.C0t+0C 0,0CE+C0 0 003+00 0.00f+C0 i

/'"N 612 0,00tt00 0 Oct+CC 0,00t+00 0.UDR+0C

(

mC1, min tur. centration, t i

4 4.74E 9) 1,SLE 01 1.55E+01 hf.028+CO 30 Tc VD? WBC.

A(C)

=

24 3.505 04 8.618 04 1.05D 01 6.885 02

'*.79E 04 48 6.63C 07 2.21E 06 v.?CR C4 95 a.)(E 12 A 4SE 11 1.'/75-09 8./JR.10 120 1.618 14 3.695 14 4.lus-12 2.09m 12 168 0.00t+00 0.03k400 C.0CE+03 0.00E+30 316 0.0CE+00 0.COE+00 0.0tE+Vu C.00E*00 671 0.00E*00 C. Cot +0J

0. 00E +0C C.0CE+00 i.41, max concentration, t EgtA1E+02

. At Te D De WN '. A(0) 3 2.03DICO A.15:40C 8.3tE*02

'.758+C1 s

24 1.442 01 4.61E 01 6.84B+01 40 1 055-03 2.ntE C2 2.67R+00 1.336+00 PC 1 6AE.05 5.61R 05 6.64r 03 3.177-31 120 8.24t C7 2.748.nE 3.24E.04 1.55E-0e 168 1.96E 09 C.53E 09

?.993 01 3.65C C7 336 C.00E+09 0.00EiOO 0.00E+00 3.03E.00 E'%

C.0CGiOO 0.002:0C 0.0Cr+C0 0 00E+0C i

g

..+..

i

~ -- py

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