Question

Describe the Phase I and clinical pharmacology work which were conducted for your newly marketed compound. How would this be different if it were a large or small molecule?

Answer 1

Phase I Pharmacelagy Tx neuly marteied Compaund Phase study invalves the genexally camspond tothe t adminishatinn to humans to develop a aiical Phase he ioitial Studies ansists of administeriog a single dose ot the test chug and closely obseaing the subject, if ho adverse redction ocurs, he dose is inuased progiesvel predetemined blood levcl i reached ox toxlety Super venes Jf nountonand effeeds relulty frem-single doses Shoart tem multiple dase shudies axe there cautions Small sample teks mag employ gradually 0ueasing Sample size. The tolal humber of subjeckos Patienti fa phaie 4 genealby The sample commabaly ansist of healthy Yolunteers reuthes than Patlents. The emphasis is upon safehy of inlreacing eloses,metabo lism and pharppatalogical action of chug emeige out with the falommction that deaides the mast ppnpriate dosing regimen to be employed in the furthes trials The study felentifies a dosing Tegimen having opti a perfaammed no moxe than 20 to 20 These tials Should toward and at the same time with minimum un- Tound the mum n theae nu sesie no sei0ur safety effects Pavectigetor mc ontinue phase tial are

chug Cliaical phanmaiol Dgy3 develop ment Poclude Conhalled Rind Heathy yolunteas (20-30) (Phase I) Contolled Blind Randamixed patientsIs0-200) Open 12nconholled patientsC1000-2000 0Y more) -Phase TT shidie) n chaical studie Cthuman beings) reported Adver se fvenli for the approyal are demonstaed Pn Phase sludies The chrical study for new sereeal The clinical Pharma colasy studhes Rewards a Metabalism of dosage foin fnew dnug AMECDbcorptinn cispihution metabolicm exGre tinn) efficaryssallet Maximum tolerable dase, & last ) পd रcac nih addinnoncl sne pantially dife neported along cth large or smalla moleade, There aze the Same but not diffy o1 studhes are during the synthesis isalahan feimeataton of neu chug malecale beaause the approval of new maleculeto be o ०४ mentioned Shudie R toimportant to pertarm deeloped these toin be pabove