 |
|
|
|
|
I. Introduction |
|
|
|
| |
 |
|
|
|
|
II. Interdisciplinary Interactions |
|
|
|
| |
 |
|
|
|
|
III. The Dynamics of Change |
|
|
|
| |
 |
|
|
|
|
IV. The Current Situation |
|
|
|
| |
 |
|
|
|
|
A. Clinical Pharmacology |
|
|
|
| |
 |
|
|
|
|
B. Clinical Development |
|
|
|
| |
 |
|
|
|
|
V. The Need for Change, Rationalization, Efficacy, and Economy |
|
|
|
| |
 |
|
|
|
|
A. Prospective Planning |
|
|
|
| |
 |
|
|
|
|
B. Discovery |
|
|
|
| |
 |
|
|
|
|
C. Nonclinical Development |
|
|
|
| |
 |
|
|
|
|
D. Clinical Pharmacology and Clinical Pharmacokinetic Studies |
|
|
|
| |
 |
|
|
|
|
E. Clinical Development |
|
|
|
| |
 |
|
|
|
|
VI. Summary and Conclusions |
|
|
|
| |
 |
|
|
|
|
References |
|
|
|
| |