Financial Activities and Issues
Financial Activities and Issues We demand that big business give the people a square deal; in return we must insist that when any one engaged in big business honestly endeavors…
The Future of Drug Discovery and Development
The Future of Drug Discovery and Development The future just ain’t what it used to be. –Attributed to Yogi Berra. Like most people, the author always been fascinated with forecasts…
Computer Simulations and Modeling
Computer Simulations and Modeling The aim of science is, on the one hand, as complete a comprehension as possible of the connection between perceptible experiences in their totality, and, on…
Management of Drug Development Case Studies
Management of Drug Development Case Studies Men are going to have to learn to be managers in a world where the organization will come close to consisting of all chiefs…
Regulatory Affairs Case Studies
Regulatory Affairs Case Studies Regulatory affairs staff and managers should be people who look for reasons and ways to get regulatory agencies to agree with the company’s proposals, rather than…
Clinical Case Studies
Clinical Case Studies Ultimately the focus of attention in dealing with poor clinical performance must be on prevention and early detection as much as having mechanisms to deal with the…
Introduction
Introduction The case studies presented in Chapters 116, 117, 118 were originally published by the author in Case Studies in Pharmaceutical and Biotech R&D by Prous Science (www.prous. com). The…
Keys for Pharmaceutical and Development Success
Keys for Pharmaceutical and Development Success The intensity of a conviction that a hypothesis is true has no bearing over whether it is true or not. –Peter Medawar Doctor of…
Licensing Activities and Issues
Licensing Activities and Issues Underlying most arguments against the free market is a lack of belief in freedom itself. –Milton Friedman, economist. A few bad reasons for doing something neutralize…
Production Activities and Issues
Production Activities and Issues We can no longer live with commonly accepted levels of mistakes, defects, material not suited to the job, people on the job that do not know…
