Basic Statistics and
`
`Pharmaceutical
`Statistical
`
`Applications
`
`James E. DE.- Muth
`
`Hill] “In MIMI“;- N'Pc'. 5d]! JIIII
`sum-mm
`cum-n1. 11m awn-MJLC
`
`mjflzaflfiimm
`
`mahnflfluflflnm-uuM-Iuw
`II)?! T II J- 1] £l
`Jinn-mm] 5mmflm-ID.DW1-ITH-1
`inn-ml W IM Hm-IJ “HMS-SW
`mlmmmmmmm m mp1.n-gmh1mu.npnudmwn
`“Mmflmmw Fund: madmnllm PEI-mm
`museummflmmmmmunmmmmmwmlmcummm
`whiwhwmwml Hum-m rmncwndntm-r
`mmdmllmmummmmmmuwm-qlmwmanta-mu.
`rill-child.n'flh¢l min-II
`rIflI'Ir HIP-rum: hut-hit irn't-lfl. Iridium: ill-flwr-l'. “Emil—"lg. Ind
`mall-[Mlnwlnfwuw II'I'IIl'flll'Il'll'llil-I-PIL vim-1 mummm [uh-1H1.
`Fun-plenummflmflfimwmewummlmt¢hmmmmmnfluu
`rmmwmwmlh rmriflfirmflmmllr Wm H: Hale-mid l'lrrw.
`Wmmmmn-mi-mcctuumrmfi ummwmmmwan
`lulu-trim Fvlu'lmlflnulhlhluhlmfllihhlfi luuhyhm_lul1ln
`Iyflmnfplyr—rlhulnnw
`WEN-Huihudxlflmm-mmyhlrflnfilnmmmmmmflmm
`furhflsmndwl-fllnmlwwllfim
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`Lila-1 lit-alri- mhmm DIM
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`Clint I-rnnl .m'l‘k I'mm IH Lilli-5' a“:th
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`informa
`..M'.-a::.+::r::mm :rficafirgmm
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`Chapman E: HaIUCRC
`mum amp
`Ell-Fl [m mm
`
`cup-ma HII'CIE Inn mun-e
`lwnmmmmm Thi- an.
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`Hill |I|ll|ll||lll|l|l
`5MPvWH-DWA
`
`Mylan V. MonoSol
`
`M°“°S°1E"'2°18
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`Mylan v. MonoSol
`IPR2017-00200
`MonoSol Ex. 2018
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`132
`
`all“?
`
`Emmi-nu Emmi: Ind Tel-rim Unit:
`
`133
`
`plun'ng ui' lie rinses. HMWI'. Ill-ere Inn-em in b: u dw-nw'd Ira-Id in the I'M-I'-
`wriglils urlhtlablctsmdlhcupflamrshouldnukn ndjumuhi hymn:
`mm: wailhlwklolhi: luau mun.
`Sim-Him ml. Iflfllfl- Mar Ifl'l'll‘ rllpl In used for control chum.
`lnfltunufl.$cfn5lhuufluntmrplfimtnfidlud udlherflullsmndulln
`will an 111:: annual nhaJL When the null ample i: nulluclnd.
`Ih-i: fin: "In: in
`dmppudmdnmlwisplnnedflmbuhlhmm ill: we] Thispmces:
`mminm. arming imluding I new mm Ind excluding. Ill-r: mlinsl WM
`mmbcrcmunmrd fwlhufluhdlum.1hkyrkhnmiuufnmuldm
`“rpm-ml menu-lg: nfnullipli: mum“: dill
`A “rand rm: ul‘ comm] chili is ill: llllfllli‘fl tum at EUEUM chin-lint
`tuchllqur. II is committed! rmn: sensit'm: 1hl.n Slum cmlml alum: In run-dull
`chmgfi in lh: chm-curiale lining munilnmd {Mm I939. p.
`Th: Cufiuh
`chum an: m cfl'wiivc 'll
`radial Wilts lu mn-nI-wntml
`conditions. Th: nun: CUSUM in from lb: Elicl
`llill mound“: dflillidm I“:
`
`mullile meafiwd rein-memth ltpiwiduanminu. V'wual
`summation oldcvlllm from m Facial-ad harm puinL Thu-t is alliance of
`a mill-cause mailman whim. Ill: cumulll'm: l-m'u ul' Ihc dwinlinm ii animal}!
`large or exit-mi.er small. l-‘urlher lnlhmuiion on CUSUM It.th an be found in
`Mum‘s bout {Mm 1959.».51-70).
`
`PM Esp-hilly Ilifll
`
`Fm nip-hilin is 1mm arm: ham-ml val-“hilly nif- plum ram-iii.“
`any undesirable spa-till m II'III might
`influx-e wrinhilila'.
`It Is the mullm
`viliIbHJ'Iydu-nsulnlj Income-m1: mflmuing il Human-nil nIllII:
`dam In which line prams is meeting “I! numfacturhl raquiremls. II
`in Ill:
`repeatabilin and dummy nl‘ Iluu pun-cm and il- rulllive in In: mum
`“Mun in 'lflTl'l ufspncificn'iun limit: lur'lh-i: product.
`Possible spacial cum of variability include diITan-ni Main site; dlfl'mmt
`:quipmml. Ind diffmnl m running llul cqul'pm-I'm. DnI my in nll'nu'rull
`Ill-use minim illumllncl duauainglkmnpmmranthc mulling;
`mm the Inn: blink of mllailll.
`Eludifl ul' pm umbilin an: dcsigncd In dclu'mlni: wlm lhl: pm ii
`“Glplfllln uf dining undu cmtmllnd cmdifims {mu-Vin; any will mulu lid.-
`Vnriali-ililfl. mm belefil of studying ll'll‘.‘ pm 1:1lein in la Iii-landm- It":
`Inhility urmmwmmmmuramm wimihn m
`spacifimims or by comparing lhe nunnql “liability of I mhle when: 1iiirilli. Ill:
`prom milk-tin: I'I'I'Iitl.
`Pram: cm'bili‘i'y m :11: protein unluum: lint is “in email" wilh the
`spmirxalim limit: by mum-HUM upmle indlnu. Thin imp-rim i: I ruin of
`the din-Mm barium Ill: pm np-ncifinlium [c.lllnd 11!: glacificilian width till fill:
`dc'rinilunofd: mm “Jun. band on six. Irma: slnuhddniltiun units {Ida-rad
`mummwimm.A'upahlapmcm*itd¢finduumluwhkhlllihc
`mum-nu I'III
`imit- lhe madam-finial Epmificu'lun lip-um {Flam Lu}.
`
`Figure 16- llllmuiun of; distilmlinn within “utilization limits.
`
`Capabilily indium: an mall-um mluynd In Flu-u: Eli-i: dim-lamina from n
`lpncifinplwm 'nl [climb-Indrth upwifinlinm. Clplhiliry indinfl I":
`mummfivnmmfimiflhmiumwhk ul'nmclinl
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`only n'hunt‘n-u'eisllu'nemple stimuliIIIrlminhmul‘Sflmlap-uinu. 111m
`lhmflhnmnmuiwdlupoimmnthm Iflsmmmhfimfiv:
`alarm-final.
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`Sevflflnrmbokltundmfheulculujmoilhnwfilmiindlm.Tisthe
`mammafixmmmflislhepmmnuflahlhmaf
`dhpnsiunbundunhlmmiulupnmuilnflwmiuflmedflmmtm
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`Tim-1m mile wifiuliun limits. The summation mun ll'fl'le difl‘m
`mtmfimfifl.
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`flier-flirmm mm = U51. — 15!.
`
`Eq. 'i'.li$
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`mthmflhhm-h-w+3mwlsh-WAsmin
`Ill: pm M, minutely 99.?“- ufllin m undet I l'lfl'I'I-IJ dilfl'lll'llllflll
`mid hwfllillhspluxurrlinwflmflm.mihmh1wfilhililrmipfld
`inmflmfldhawalmflvuiuimufwmh'nfltlysinsigmn.
`C, illtinpln inan Inllln Ihnmnpuhl:
`uflll: mill-uni“
`lin'lilsldlheumlvl'iltm nflhnpmmsinprmudufiulehmlimu
`Mmumawhfluumllq'mmmmqakuIMu
`Tallinn:
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`131
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`mum-r r
`
`cm ln'llmll ind Tull-nun min
`
`135
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`
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`c.=1.33
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`q-zm
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`Figure 1.1 Dilu'ih'uliom [at ruin: C, values.
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`UflFlfl
`C =—-—----
`ficr
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`II?
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`Eq-
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`Va'ioui C,tci:fluu-cllluumudtn Figlm: 1?. Il'lhc C, islanth
`pranfllufinl'mn tum-and: wiflmflmmdalimifim nmm’del‘w myrtle
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`W5Ipufliminur¢gudlm ufwmmmmlsIMMEMm
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`0.3%{1m-W.m}derm uiflhdflhdifflepmiimuflumm
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`illifh Hum the mum leml chum In: :xullul Fur incl mum
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`TIME 14 C, llI"IIIJI=
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`“Itth writ: Dis:th is}:
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`M Q Mamba! W
`in
`mm
`2301:
`we
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`I331
`151
`15
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`um:
`ms
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`2.000
`um:
`51}
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`“hem. Aha. mam behighly hummundnflsludingiflhdu i: an:
`angled Hum I mnuuyd'nm'iblmd populuixm.1"nbll: 1.4
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`mu lihlyunprwmumhiliw will fill mmmsmifim‘mwm-u
`In: than DEL—HELL Fur :umplt. will: I C, H21} Mm a m dimibulim
`what I2 lilnuwauldfitbumnmlthSLandLSLlIlmmflchlfimlighim
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`minutorunil‘m
`Somephmfiul mm m
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`. LEE-p p-LSI.
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`3dr
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`C’,‘ In
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`E1113
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`11mm:amuletmumwill»:Win-umaxim-nil:III-apal-aa-thnarn-mlin:rum-1:1:u-rmi:amli‘umlf}.L [h]:
`mmbuawufldhuibudmwinmmd.wcfl maybe
`medmmdnuumeupamdpumm‘dzfocfiwpmdmmshdhrmlhrfi.
`Anulmliwnflhodrutcninufingmcflia:
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`CF. =c,rJ—u
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`E4119
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`whethflmnkddhmbflmlhrmidmhunflhcqmiflufimrmnlnd
`hmmg MI‘VMWnflmm-elwm mmnwmm
`mkflliomhafliflmflmnnfiehukuhlflufiflm
`
`=UEL+LH2
`
`Eq. no
`
`mulmhMMtflh‘mIn-wm
`
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