'Bid dosing' presentation slideshows

1.01k views • 87 slides

Design of Dose Response Clinical Trials

Design of Dose Response Clinical Trials. Boston Chapter of ASA April 10, 2006 Naitee Ting, Pfizer Global R&D. Drug Development Process. Drug Discovery Non-clinical Development Clinical Development Phase I Clinical pharmacology (PK/PD, MTD) Phase II Drug efficacy/safety, dose ranging

1.38k views • 45 slides

Division of Anti-Infective and Ophthalmology Products Advisory Committee Meeting for Difluprednate

Division of Anti-Infective and Ophthalmology Products Advisory Committee Meeting for Difluprednate Sonal D. Wadhwa, MD US Food and Drug Administration Medical Officer May 29, 2008 Applicant Information Applicant: Sirion Therapeutics 3110 Cherry Palm Drive, Suite 340

1.88k views • 41 slides

Division of Anti-Infective and Ophthalmology Products Advisory Committee Meeting for Difluprednate

Division of Anti-Infective and Ophthalmology Products Advisory Committee Meeting for Difluprednate. Sonal D. Wadhwa, MD US Food and Drug Administration Medical Officer May 29, 2008. Applicant Information. Applicant: Sirion Therapeutics 3110 Cherry Palm Drive, Suite 340

654 views • 41 slides

Anti-Infective Perspective

Anti-Infective Perspective. Anti-Viral Advisory Committee Meeting July 25th, 2000 Alexander Rakowsky, M.D. Medical Team Leader/DAIDP/ODE4/CDER. Proper Perspective. Focus can be on: new drug development versus changes in dosing/formulation/combinations with approved drugs

420 views • 23 slides

ARTEMIS: Phase III study design

369 views • 16 slides

O pioids

O pioids. Clinical Case.

283 views • 11 slides