fate, Before thet, Peers: Moves ein sy es | rae Ge Subnet) ) [von Subanittel | “em Predins (pag Discos L Pett | Ot Deepest | dectgaat 2 10 Jenne = ¢ Trikil Spattesis 4g Satslance | rT — Vhorddory Shodres | 4 suiurol stacker L Jarre | 3-6 gears x! Preclinical Researeh - > Durie thus ste o Show er evaluates the deugh ctoeie. sud pharmacdtogecal Ghee —tleough tn vito _tenhing aud in vivo Jaboredors aninral teehinoye U Cg 3 the phanactegy of the meus dug, id's —plorteacakinehic furans Sue oa ADME ond hal} - Lie esd_Yharmaady —_| parameters Such wacchanism of action and__evtimertea of — >! There beach eA jech aure__assessed | s fvet ce \__ hucies velahing ste octeetagy ielading Concinepepoh “Aeahgatcl ene__Carmied, adn. ee Bs : 2M sh ee WS EDAS retusa ot —Ahet sponser shouted dev lof —* = peweelige fob | oh the eg, eterna ashe esl — ok Nad dun sheeta ah; aioe): asic Couduc __shorh— term - | renging tots tucula Bosecths , Apa te th hy, jenn she thea 2B dl y dived studies * Clinical \inieal_Stege = ical Sege. development of botential dug Canditety put oy 2 | copy oh Hamasetcal elit dale eich are Commnaly | Conducted in 4 ha = # Phase o | Micce dosing ‘Tals Sub tharmacaleyitel dnses of respective dug, Candidates ae administered do human Volunteers - paces brovides carly pharmacokinetic _data_in humans aed sly —_teduires minimal preclinical _tuvicolegy _cufety ashing PA Micro do s__ defined as tooth of th. Phemaaleel = dose (or predicted phan wslogivat dow) & a maximum sf on > Dishuchve feahurer tuclude a ingle Sub Aherabeure doses ef ‘the + the adminishation of § shay dug foe _small_number ef subjects (10-1) + Purpose ts to gether preliminary dala oy the. ages Phamacakinchis aud bharmacedy namie| > He gives mo dake ow skely sud efhicary, lone te _sawle drug Candidates in order to decide ec e _ which has_4 take forward for further development. 4 Pharmacckimehe pavameters i humans 4 ialss —~ | tay parkeiparts) - 20 to 100 healthy Volunteers oF beole with | fet beet ‘ fee . che disease / condition. egih ct the Ghudy] - Several _Howths {heey og [Penpose | < Safely and dosage pepe j : 2 studies designed mainly te investigate the safety | tolerability pharmacokinehes aud pharmacedynamits ef an _inveshigational drug f “4 4 in hunrans. > 1) _bossible MTD (Maximum tolerated Dose) is idenhified. 3 DAs study frogresses side ejects associated with increared dosage ore determined > Generally, normal Volunteers without Confounding diseases or Concuvrent meditdhons ave recruited 49 _aricipate in Phase T —_|_ trials eee | toct Anh meobla che agents and for Certain disease states aud —_ +o__avid tials tn normal Subjects , M maybe preferred to — begin trials ina patioit__ population J eeas doiga - Uncbliitze zonal ctasdipes SS Pliase =) ihe aie ee a ey [__—— = = mo i Dae she) CME Aneaing doe — chads) > Srrall_ group ok Subjects are gia > Multiple Asceendrug — dose hel a_ Single dose of the drug chile ave Conducted to better they are observed aud tested for a understand the _ phannacckimety peiod of time. 4 pharmacodgndmia of multiple DT ahey do wot cehibit ang closes of the neg, adverse side effects, and the fharmacokinetie data i$ roughly im line with predicted cafe Values che dose ik exdlatedl , and a ned Group of Subjects i then given a higher dose. this is Coutinued ual _recaleul ated phamacolinch’ Safety levels ave reached ov intolerable Stde effects Stark Showing up at chick point the drag, is said 4p here reached Ahe maximum dolerttect dase (MT0)._ [ey beaters) - up fo Several hundred hea! ea the _ disease fcoudcton. | > Tn he subjects ¢ the disease doug is being developed > hey should be __healttay _in_derme oftheir disease dud free oh__ether _senoug medical illnesses. ————_—_———_ I Leng ef the shud = Several mouths -40 2 years. Cee Purpose = Efficacy and Side Effects T ees | His designed. © assess the therafeuble efficacy ofthe sraatanert dru asswell ag to cowhuue phase T safety assessments in a Larger grup ek, volunteers. > Hang experimental drugs which fail tend to do so during the phase IT _bials shen the dug discovered nat to work as planned por do have toxic effects, Tt focuses ows * Determinabon ok dose and dosage regimen ok cthe ded to. be used in _atey_ studies. Evaluation ok afferent Aaget populations and therapeutic veginacns of the drug. Lt Eaveshiga hon of drag- Aru _iuctera chins ~—_|_]Stua = Single blinded + placebo Controlled.= — pt Phbse PALS Sto ovlntewas hae = Phase | ye + TA is_shuithially designed to 1 is Specbeally dev | ih assess dosing. _refuirements. Shady cteay, i Chow el) the drug ony \ (hoo much drug should be Sa B given) 7 the pst don) ia *® Phase M1 trials - Study participants) ~ 300 40 3,000 volunteers tho have the disease or condihon Length of aay] >A 404 years Purpose} - EfBeacy aud monitoring oh ddverse reachons, > Phase T) trals are the last stage before clinical Abbroval for _a new eas ov device. > By his shade) there with be Convincing evidence of the Safety sk dhe drug or dewree aud it's efca in trea foudihion fo people sho have the ehich tf was devel ped. > these Studies shoutd be intended do provide 4 adeduate basi tov marketing, Abpro val. => Phase 3 Sdudves provide mest of “the Safely data. j 7, tt, fouuses_ on:{ rons \ i / + Dose-response relationship * Wider target _ populalron + Development ef inshuchions for use or funduct label Phase i —= ——— — = v Phase Tp #A_shady started prior to _| Phase TA | Trials Caniout oleic, tubers or in _a_shecial_ Category appeal avd vhoie priman, |= Regulatory requirement for NDA. iwtenbion is subbert ok * Tk also_includes studies with. publications rather than |__-he aint fo include claims into vegishation ov label chammes he label_as well as postmarketing : |__ Commitments. Ls Phase 3 ‘rials are designed 40 Compare it do other Commonly used _eatments Br the Same _Condhien Cit awilatle) or Compared tO a flacebo. these shudits can be ferfermed ina blinded manner. sa le Evaluate interachions with other treatments that. meg be used at the Same time as the Saveshigetional new saa a =) Provide adequste information de determine tha ind ration for dick the drug will be _labeted it St appraved afew on doug’: wse_thet marketing 2s well as any | Sheuid be stated in the aleliny Cog the labeling would cesbret the _dwg's used adults) i = Randomized and Conbolled| New >> NDA is dene following successful _ Lomplehos ep yhases of human clinical rials. a fel | > the NDA apple how is the Velcle throug h_ rn “Inbal. oad sleet eee sponsers formally _profese that the _ FDA abhreve a pharmaceutical fo sale and marketing. the dats gathered duying _autmal shdis dad human Chinteal _btak > of: @n__tnveshgahional_new dug CINDY hecome part of the NDA. the goals of the NDA ave _4e provide enough infra ten fo permit DA veviewer to reach the ‘fellewing key decisions + + whether the drug is safe and effective Fh bent use), and whether the benefit of the diva coe outweigh the risks. ‘whether the drags proposed labeling Chackage insert) Ajprpriate , and what it should coutarn ¢ whether th, metheds used im _manfachinng the drug cid lonbels used to _marnta’n the drug’ duality are adeduate to preserve the drug's identity 1 shength » quality end parity 4 lejislahon, the FDA ig allowey 6 Mouths review en NDA filing. # Phase WZ tials- [study parbcpants) = Several thousand Volanteziy the. have She. disease | conditionpe f [fF] = Satey md ing [> phase 4 chia ave carried out once the drug oy dewve |__has been approved ty EDA during the Port - Harket |__Safety Honitring ‘ = this _phase_is ako _Kenown as __Post_Merketia and_is_canric_out once the caudate drag Suyveillance (PMS) % approved ds. drug and marketed as _a medicinal _froduct. = this phase aims do Find owt 4th. diag safety prohle in _a Jarge pabient. pool acrss the world and fo estatlah iff safely profile. = _khe Post-launch safety mourbnng helps te detect _vave or long-term adverse effec th the dug over_4 lee _pahiert population aud timescale than was possible dung a Clinteat foal. Study design] - Uncontrolled, observational eg Sn