Investigational New Drug (IND) Application PDF
Document Details
Tags
Related
- Postal Assistants Induction Training Reading Material PDF
- Organizational Behavior - Communication (IND) PDF
- Organizational Behavior - Communication (IND) PDF
- Regulatory Review Pathways (IND to BLA, CTA to MAA) PDF
- Indian Financial System: Introduction and Components
- Ind AS 16 PDF - Property, Plant & Equipment Accounting
Summary
This document provides an overview of the Investigational New Drug (IND) application process, covering various aspects such as types of applications, data requirements for submission, and roles of regulatory authorities like FDA and COSCO. It also highlights different situations and types of IND applications such as investigator-initiated trials, emergency use and special applications designed for severely threatened conditions. The document also discusses the screening process for preferred compounds.
Full Transcript
Tvutig atieonal New Daye (IND) APplkuien Ato the durcenul Completin o ne clinicnl neeoth developen ( JponaemI bmat dn N DA t epeetive 1pulatoy authunily 2uh a ron in us COSCO in indiaetei arelen tu 9:tant clinica 1Cheu...
Tvutig atieonal New Daye (IND) APplkuien Ato the durcenul Completin o ne clinicnl neeoth developen ( JponaemI bmat dn N DA t epeetive 1pulatoy authunily 2uh a ron in us COSCO in indiaetei arelen tu 9:tant clinica 1Cheuhdh I n the. TND Aplitation Rellouling -things wa myt intude a) fminl study data toiaty dile mta inanmdim clinical podtals Cskudy plon) Ron 8-14diey to be Conducre d e) e) Datu o Cny Pniad hymqn neaanth. Tnomdin about the nvelgatey a) fny adellonal data Aax 9ubnithng TND Applitution 9nespetive RA 1evie all h data fSadsied, thy goant th 8poes t bgtn clinical ia 94 I I take 30 Go das toto M h data o gubmiion to opproval fo clinlc yre JR TND)APrliectio, Tnivetigaton IND Applicaion> an thiinthis application i Subrnited by physician who a both inihate, and Concluct and invuhgtion unclon midt ate diketiom. te investga dyg adwinidta and ds penie phgsidan might 3ubnith D nesenuh ND appletom to pHopoe shuy fAn unaproved dug tn appioved doyg fa ned indication a tn apparoved pauecuet daug in a neo patenty opplicatiom Emengenty uhed INO APpli caduan ALlos FDA to Dubhorsecd usecd o dn in an eepesutnmetl énmensgency &uation tht doe nat alloud ine Ro 8ubmlaion th an NO Appt caion intn Qctordane lith I CFR Secten 312 23 0 Section 312-20 Treadtmet IND Appllcatian- hu oppicaion u 9ubmiedbrpenimntal daug 8hosig Pnoimy in clinicatesting Seve on emida like thodbing Condtion while a inal cliniblwusk is Conducted and he FDA 9Rvei uw takes plared n the Case &Sexdous dal a daug 0nd'na mey be Mae qvailbu fe Toehneant de duing u Phie bre , invethigalon 0A4fan clinicadials h eve bten Complded SCneening IND Applht atien 9 i lled fo multple konly Compound feutdiy intn duzd to Serreniy puprujaed Eompotund tomldion h e prapalee Compound Can be davelop Unde a Sebrlai TND 9t Con alsp be wed p Srening dilehany suth eAtens and otho degivatives that ahe cheically diilenent a phomnatodyngic &imiln IND Mevew gnd Keport -
