Discussing Laboratory Setup and Commercialization of Potent Drug L NAT in the Market

Abstract

ABSTRACTDrug development i> an expcnstvc, long and bigh-nsk bu"n~s takmg 10-15 yean. and is associated wtth u high aurition rote. h t; driven by medical need. disca~c prevalence and the likelihood of success. Drug candtdatc bClcct ion is an iterative process between chemistry and biology, relining the molecular propcrttcs until a comjl{)und suitnblc for udvancing to man is found. Typically. about one tn a thousand synthestscd compounds is ever selected for progression to the cltnic. l'rior 10 administr31ion to humans, the pham1acology and biochemistry llf the drug is established using an extensive range of in vitro and in vivo test procedures. h is also a regulatory requirement that !he drug is administered to ammals to assess its safety. Later-stag< ammaltest•ns is also requtred 10 assess carcinogentcity and eiTects on the reproductive system. Cltnical phases of drug de,-elopment include phase I in healthy \Oiunteers 10 assess primarily pharmacokinctte>, safety and tolerahon, pha'e II tn a cohort of patierus with the targc:t di>ease 10 c.tablisb efficacy aod dose-r.,.porue relationship and large-scale phase Jll studies to oonftnn safety and efficacy. Experience tells us that approximately only I in 10 drugs that start the clinical pha;e wtll make 11 to the market. Each drug must demonstrate safety and efficacy in the intended patient population and tiS benefits must outwetgh tis mk' before it will be approved by the regulatory agencies. Strict regulatory standards govern the conduct of preclinical and clinical tria ls as well as the manufacturing of pharmaceutical products. The assessment of the nc\\ medicinal product's sa let> cont inues beyond the initial drug approval through post-marketing moot1onng ot adverse rvenl•. In th" report a brief financial report for ""tablishing a drug development laboratory wtlh raismg fundang lor startup has h<~'Tl briefly elucidated and potent ntdioprotective drug named L-=' Yl '' supposed to be addre,sed to the market which could address the stde effects caused by radtOtherap)