11th Lecture Winter Course - Drug Research Synopsis
Drug Research - a Synopsis Medical Need and the Real Situation in Drug Research The Long Way to the Market for a Therapeutic Drug The Reality in Drug Research Some Pioneers in Drug Research Modern Drug Research has an Empirical Basis Drug Research ‑ How to find a drug? Which Problems are Facing Drug Researchers? Principles of Drug Research How can the new Technologies be helpful? Challenges and Solutions Types of Drugs Drug Discovery and Development Cycle Process Network and Technology Mapping for NCEs Processes in Preclinical Drug Research Chemical Library - MOSS Laboratory Flow of Material and Information High Throughput Testing Robot Drug Optimization Process Network and Technology Mapping for NBEs Biologics Specificities		The Market for Biologics is Extremely Dynamic Biologics Development has a Different Failure Spectrum from SMOLs ADME ADME Studies Requeired for an IND More ADME Studies .. Clinical Studies Clinical Development - Phase I Studies Clinical Development / Phase II Studies Clinical Development / Phase III Studies Clinical Development / Phase IV Studies Clinical Trials Regimen in Overview Clinical Trials are Conducted Blinded Clinical Trials are Conducted Randomized Marketing Authorisation Application (MAA) Required Documentation for MAA Getting the Drug to the Market The Registration Process As Defined by the FDA Food and Drug Administration (FDA) Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and EMEA A Persisting Dilemma
©    Klaus P. Schäfer - Last Update  12.05.2003