'New drug development' presentation slideshows

Pharmacology and Medication Administration

1.96k views • 168 slides

Pharmacology

Pharmacology. Introduction & Pharmacokinetic Principles Sean Burfeind, ATC, LAT, OTC. Objectives. Define drug; differentiate between names Explain difference between generic name & drug Explain drug classification FDA role in development and recall Apply drug concepts

1.16k views • 67 slides

Regulatory Framework for Phase I & Clinical Pharmacology Studies

Regulatory Framework for Phase I & Clinical Pharmacology Studies. Funmilayo O. Ajayi, PhD, FCP, FIST Procter & Gamble Cincinnati, Ohio. Talk Overview. Background Information: history of drug approval regulation drug development paradigm Pre-clinical Studies & Required Data for IND

595 views • 43 slides

Cultural, Legal, and Ethical Considerations

Cultural, Legal, and Ethical Considerations. Jan Bazner-Chandler RN, MSN, CNS, CPNP. Federal Food and Drugs ACT . FFDA Required drug manufactures to list on the drug product label the presences of dangerous and possible addicting substances. U.S. Pharmacopeia.

625 views • 37 slides

Clinical Trial Designs for the Evaluation of Prognostic & Predictive Classifiers

Clinical Trial Designs for the Evaluation of Prognostic & Predictive Classifiers. Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://brb.nci.nih.gov. Validation = Fitness for Intended Use. Intended Uses. Prognostic biomarkers

353 views • 35 slides

Presented by Lee S. Simon, MD Division Director Analgesic, Anti-inflammatory and Ophthalmology Drug Products ODEV, CDER,

Presented by Lee S. Simon, MD Division Director Analgesic, Anti-inflammatory and Ophthalmology Drug Products ODEV, CDER, FDA at the Arthritis Advisory Committee meeting on 07/30/02. Pain. We reviewed acute and chronic pain Clinical approach Mechanistic approach. Pain.

402 views • 18 slides

Kelly Bachta , MD PhD Ramakrishnan Laboratory UW Internal Medicine Residency

Research In Progress. Towards an Understanding of the role of ESAT-6 in Mycobacterial Granuloma Formation. Kelly Bachta , MD PhD Ramakrishnan Laboratory UW Internal Medicine Residency. Why is TB so scary? Drug Resistance.

309 views • 17 slides

New Drug Approval Process

666 views • 16 slides

AGEC 608: Lecture 17

AGEC 608: Lecture 17. Objective: Review the main aspects of cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). Readings: Boardman, Chapter 17 Homework #5: Chapter 13, problem 3 Chapter 14, problem 3 Chapter 17, problem 1 due: next class - April 24.

304 views • 15 slides

Statistics in Drug Development

Statistics in Drug Development. Mark Rothmann, Ph. D.* Division of Biometrics I Food and Drug Administration. * The views expressed here are those of the author and not necessarily those of the FDA. . Various Indications for Drugs. For example: Headache/Pain medicine, psychiatric drugs,

335 views • 12 slides

Effects of reimportation on new drug development

Effects of reimportation on new drug development. Frank R. Lichtenberg frank.lichtenberg@columbia.edu Columbia University and National Bureau of Economic Research. Hypothesis.

197 views • 10 slides

Genetic Diseases of Children The Role of Orphan Drugs

219 views • 9 slides

March 2nd

March 2nd . 1. Which of the following is true?. The FDA pulled Vioxx from the market Merck shares are trading about $35 Pfizer has pulled both Celebrex and Bextra from the market Merck has several blockbuster drugs ready to release on the market.

179 views • 6 slides

Valuable But Vulnerable: Limitless Possibilities, Growing Challenges

142 views • 1 slides