2) Drug Development Phases ¥ |Pre= clinical studies: 3 {ese Clinical Studies axe tests that take place] in a sclentifically controlted Setting using | cell cultuses and animals as modeis- na rT The geal of preclinical studies is te predic __ what the body does to the dug candidate Fi Ceharmacokineticsy » what the dvug candiate does to the body C pharmacodynamics) > and __jwhether the dug candidate may pose | potential beatth hazards o» toxic side effets This phase ~requise 1-S yersS to 2 years fos completion: * (OBIeCEINES $= > Preclinical studies debesmine the psoperties lof an ee lovestHgational product Toocicology = poteneyHal of the d loci bemeghl aimetobolites.. to kad pon Rodents | Beker ene oronrrocicolegt (BaeR= [a | _ effects: Z _[phasmacodynamics = reacHon f bel er | net and living Stra [including +he process of bodily TESPONGe5~ Ho phasmacatagical » biochemical 5 Physlologig- lond +herapeuHc effects - > > _|phasmatokineHes — process of bodily absoxp Ashi button , Metabolism _|Ond- -excreHon CADMBP) OF compounds ¢ Medici nes. + | Animal Used — Two Spectes ave used: one yodent€ one non sedent_ RodentS = Rats 5 “mice > gasrien spits i Tabbit , Hamster : | i {! ae Lah Rodents — cat'sdaqs pmmonkey he Species ets chetoe dikes. hee he ame phasmace kineHic _profile aS tn Humans! -tleaui jeri peas Seer @ mela Oaitgtrred o>! aro [Assessment of Safety Index §other “Saefety parameters found ave - . - a a __, Oraxium tolerable dose : __ | @_ No adwesse effect level dose : (x1 as (Data._—_] a (®) oetesming these. pavameters Fisst dose Is __ Catewlated +o be given in. clinical phase Gin haman), # -| EnVesttgatonal New Drug i= GND) > | FevestgaHonal New Drug cond) psqgram iS HHhe means by which aaphasmaceutical com Obtains pesmission to ship An expeximental drug across state lines C usualy Fo ate ToveStgatoss). before a manketing opplicat fox the dvug has been approved. — 2 | - the Food & Drug Administaton CRDAD eviews atone ict DD applicahon for Safety To assave That weseasch Subsjects will not. Subjected ho unreasonable wis. =FRe0 CenHiet® ilo oj abs" qubp s96 TR Hea TiceFien | is ap candidate ee usaa : | fa I bot ss ape : == —— "© Gaanstakive composition of +he frag Name a add-sess of Supplies of ong) nels New z-ie chug sttbstance and a deci _[Sgothesis of ang new _avug Substance. vores __ 6 Statement of the methods, care _|conFrois _osed fos the “mand facrure, E r at processing RI PACKAGING of the new gd: ©) Statement coves ng au jnformation from ~ Preclinical investigatonets and any linia Studies 4 experience with the drug copies label fos the» drugs. r @ Bn descri pron of sclenHfic training: expesience considered appropriate by fhe Sponses te qualify an Jinvestigator) ag a suitable expert es een ine auf aru nr , z} aera ANIC © far ore ad Verse | objective oF ¢ dete jefficienyy”{PageNo, | =e (Data. J fox Clinical STiichs gucts Oz EXaluate Hew dygs> Medical evices, {_dlologicet Sy ior other intervations on —ipehents in shictly scientifically controled ____ | Settings. : “ { BS Sequised for Bequiatory authority GPPPOvVAl of New Therapies. Yo assess +he, SaFfeky and erticagy of on | &Xpexi mental therapy { 3 li | To evaluate, whether -the pew intesudhon jis better +han Standard therapy. © Te compare +he efficacy of +90 Standax lor masketed intesventions. i bee ) 1% [Phases tm Clinical Trial 3= i ait i iT Bibi 2G} Doeeds +) phase LZ = ‘The drug is tested in s0to1 | sel) alata heatthy volunteers +40 wolg idetermine its Safety at low doses peg enthe dug not being “as effective Og _ | anticipated - a phase tose fig Te Typical. tema 5 se in Several hundred “to = = Seierval thousand people catth targeted & disease if double blind » placed Controle trials to demonstrated itS Gpecihe efFicag, under 30%. “oF drug candidates sy syrough: 1 {| pnese Se These ase postmasketing : Susveilance Frias fH *% (Neo Drug Applicaton 2 | ~The Nd# application is thes vehicle. through ebich pharmaceutical componies formally propose that the FDA approve a new pharmaceutical, for Sale and markeHng- "~The goals ef €he NDA ave to paowlde enough Infosmaton to pestmit compe authority Jweviewer +o sreach the _ key dectsions +). eamPan [benerits of the drug “outeoeigh the wise ane |@ wWherhey the a+ug’s proposed ae pePackage jnsext) tS Appropriate , cane what i should contain: — @Bhether the methods used jn __manufachusing fhe dyug and fhe © controls ~ ___-osed to maintain +he asug’s “quali eT lave adequate to presesve ea e identity » Strength , quality, an and purity = __The “competent authoesity review he tT ae application end approve the dtug for) maskeing only if +he aug dsifound boo ; be ‘safe Sot aricEve in human ees i i os the “dug have more desivable eect ag _{Compave' to" the adverse effect - =| Byen after: the) ae rof pew dug, E goverment ghoul moniter its safety due i 2 ~ interna cHons wh) carne Wese not assessed = Lond its > ~aeehen it) is used,| (Pagano. J 7) _t NDA application contents s- F uiled reposts of preclinical Studies — Re led wepsrts of clinical etudies ga (3) Tnfosmed on composition & manufacture of drug and on control & facilities ose 1D manufacture. a (@) somples of dsug and itS jabe ling ’ Fall case fepostks of each pemson Who | o@eceived arug- needed only in limited \ciscumstances« © eoatent infosmaHon @. Material previously submitted to FDA Lin the INO oor in periodic ssepostS must tbe included by: wefewence. imethe NDA.