Science, pharmacoeconomics and ethics in drug R&D: a sustainable future scenario?

The costs associated with the development of new drugs have increased dramatically in recent years, and fewer truly innovative drugs are making their way to the market. The reversal of this trend has therefore become an urgent priority for the pharmaceutical industry. What are the factors that contribute to these costs, and to what extent can they be effectively controlled? Does the solution lie in new technologies? How is the industry dealing with these problems? And what are the ethical implications of these trends?

[1]  Tom Regan,et al.  Defending Animal Rights , 2000 .

[2]  Irene Kwan,et al.  Does animal experimentation inform human healthcare? Observations from a systematic review of international animal experiments on fluid resuscitation , 2002, BMJ : British Medical Journal.

[3]  Allen D. Roses,et al.  Genome-based pharmacogenetics and the pharmaceutical industry , 2002, Nature Reviews Drug Discovery.

[4]  M. Mitka Accelerated Approval Scrutinized , 2003 .

[5]  E. Oren,et al.  Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. , 2001, JAMA.

[6]  M. Mitka Accelerated approval scrutinized: confirmatory phase 4 studies on new drugs languish. , 2003, JAMA.

[7]  M. Mitka Economist takes aim at "big fat" US lifestyle. , 2003, JAMA.

[8]  A. Monro,et al.  Are single‐dose toxicology studies in animals adequate to support single doses of a new drug in humans? , 1996, Clinical pharmacology and therapeutics.

[9]  I. Edwards Withdrawing drugs: nefazodone, the start of the latest saga , 2003, The Lancet.

[10]  J. Lewis Post-marketing surveillance: how many patients? , 1981 .

[11]  R. W. Hansen,et al.  The price of innovation: new estimates of drug development costs. , 2003, Journal of health economics.

[12]  J. DiMasi New drug development in the United States from 1963 to 1999 , 2001, Clinical pharmacology and therapeutics.

[13]  W. Stigelman,et al.  Goodman and Gilman's the Pharmacological Basis of Therapeutics , 1986 .

[14]  B. Culliton,et al.  Post-marketing surveillance. , 1980, British medical journal.

[15]  L. Goodman,et al.  The Pharmacological Basis of Therapeutics , 1941 .

[16]  Palmer Taylor,et al.  Principles of Drug Action , 1990 .

[17]  J. Watters,et al.  Using genome-wide mapping in the mouse to identify genes that influence drug response. , 2003, TIPS - Trends in Pharmacological Sciences.

[18]  I. Wickelgren Animal Studies Raise Hopes for Spinal Cord Repair , 2002, Science.

[19]  Peter Greaves,et al.  First dose of potential new medicines to humans: how animals help , 2004, Nature Reviews Drug Discovery.

[20]  J. Farmer Learning from the cerivastatin experience , 2001, The Lancet.

[21]  J. Weinstein Pharmacogenomics--teaching old drugs new tricks. , 2000, The New England journal of medicine.

[22]  J. DiMasi,et al.  Success rates for new drugs entering clinical testing in the United States , 1995, Clinical pharmacology and therapeutics.

[23]  A. Goldstein,et al.  Principles of Drug Action. The Basis of Pharmacology , 1970 .

[24]  P. Cannon,et al.  PATHOLOGIC EFFECTS OF ELIXIR OF SULFANILAMIDE (DIETHYLENE GLYCOL) POISONING: A CLINICAL AND EXPERIMENTAL CORRELATION: FINAL REPORT , 1938 .

[25]  William D. M. Paton,et al.  Man and Mouse: Animals in Medical Research , 1984 .

[26]  E. Paul,et al.  Why animal experimentation matters : the use of animals in medical research , 2001 .

[27]  P. Lord Progress in applying genomics in drug development. , 2003, Toxicology letters.

[28]  B. Katzung Basic and Clinical Pharmacology , 1982 .

[29]  Principles of Pharmacology , 2003 .

[30]  R. Weinshilboum Inheritance and drug response. , 2003, The New England journal of medicine.

[31]  Howard L McLeod,et al.  Pharmacogenomics--drug disposition, drug targets, and side effects. , 2003, The New England journal of medicine.

[32]  Peter Lord 14 Genomic technologies and approaches in toxicology , 2003 .

[33]  J. DiMasi,et al.  Risks in new drug development: Approval success rates for investigational drugs , 2001, Clinical pharmacology and therapeutics.

[34]  L. Porterfield Principles of drug action. , 1988, AD nurse.

[35]  Janice M. Reichert,et al.  A guide to drug discovery: Trends in development and approval times for new therapeutics in the United States , 2003, Nature Reviews Drug Discovery.