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, improved quality of life, increased productivity, and importantly, extended lives. But developing medicines is a long, complex rapid pace of scientific advances is enabling a greater understanding of diseases at the molecular level.
THE BIOPHARMACEUTICAL RESEARCH AND DEVELOPMENT PROCESS Key: IND: Investigational New Drug Application, NDA: New Drug Application, BLA: Biologics License Application POTENTIAL NEW MEDICINES 1 FDA-APPROVED MEDICINE BASIC RESEARCH DRUG DISCOVERY CLINICAL TRIALS FDA REVIEW POST-APPROVAL RESEARCH & MONITORING PRE-CLINICAL. For …
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