Transcription of Biopharmaceutical Research & Development
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Biopharmaceutical Research & Development
The Process Behind New MedicinesBiopharmaceutical Research & Development : OUR industry IS POISED TO TRANSLATE OUR MOST PROMISING SCIENTIFIC BREAKTHROUGHS INTO MEANINGFUL TREATMENTS CAPABLE OF TACKLING THE MOST URGENT AND VEXING MEDICAL CHALLENGES OF OUR TIMES. WE STAND COMMITTED TO DRIVING PROGRESS FOR PATIENTS TODAY AND HOPE FOR TOMORROW. - KENNETH C. FRAZIER, CHAIRMAN & CEO, MERCKPHASE IPHASE IIPHASE IIIPHASE IVIND SUBMITTEDNDA/BLA SUBMITTEDFDA APPROVALTENSHUNDREDSTHOUSANDSNUMBER OF VOLUNTEERSTHE Biopharmaceutical Research AND Development PROCESSKey: IND: Investigational New Drug Application, NDA: New Drug Application, BLA: Biologics License ApplicationPOTENTIAL NEW MEDICINES1 FDA-APPROVEDMEDICINEBASICRESEARCHDRUGDIS COVERYCLINICAL TRIALSFDA REVIEWPOST-APPROVALRESEARCH &MONITORINGPRE-CLINICALFor patients, new medicines offer fewer side effects, fewer hospitalizations.
clinical trials. While the basic science providing a foundation to discover and develop drugs is often initiated in academia, industry often partners and contributes to basic research. It is primarily the biopharmaceutical industry where the crucial disciplines of medicinal chemistry, process chemistry and …
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