Creating a Clinical Strategy and Development Plan for a New Drug or Indication It is a good morning exercise for a research scientist to discard a pet hypothesis every day…
Evaluating a Portfolio of Investigational Drug Projects Trying to assess basic research by its practicality is like trying to judge Mozart by how much money the Salzburg Festival brings in…
Introduction This section can only present a brief synopsis of selected issues regarding clinical trials. These chapters are not intended as a primer on how to conduct clinical trials, but…
Developing Standard Operating Procedures There is no more difficult art to acquire than the art of observation, and for some men it is quite difficult to record an observation in…
Productivity and Project Success Measures of productivity are like statistics on accidents: they tell you all about the number of accidents in the home, on the road, and at the…
Overview of Safety and Risk Management Drugs, like life, are not risk free. –Anonymous DEFINITIONS AND USES OF THE TERMS SAFETY AND RISKS Safety is a frequently used word in…
Developing and Marketing Orphan Drugs for Rare Diseases Happiness comes from facing challenges and going out on a limb and taking risks. –Diane Frolov and Andrew Schneider. From Northern Lights…
Virtual Drug Development In the most spectacular example ever of the potential economic consequences of a careful examination of pharmacokinetics and pharmacodynamics, nifedipine XL converted a side effect-plagued immediate-release drug…
Compassionate Use Programs The good physician treats the disease; the great physician treats the patient who has the disease. –Sir William Osler Several different names are given to clinical programs…
Creating and Using Benchmarks Science is facts; just as houses are made of stones, so is science made of facts; but a pile of stones is not a house and…
