 |
|
|
|
|
I. Introduction |
|
|
|
| |
 |
|
|
|
|
II. Drug Acquisition |
|
|
|
| |
 |
|
|
|
|
A. Analogue Development |
|
|
|
| |
 |
|
|
|
|
B. Screening |
|
|
|
| |
 |
|
|
|
|
C. Serendipity |
|
|
|
| |
 |
|
|
|
|
D. Rational Development |
|
|
|
| |
 |
|
|
|
|
III. Animal Toxicology as Applied to Anticancer Drugs |
|
|
|
| |
 |
|
|
|
|
IV. Methodological Issues in Phase I Trials |
|
|
|
| |
 |
|
|
|
|
A. Patient Selection |
|
|
|
| |
 |
|
|
|
|
B. Selection of Starting Dose |
|
|
|
| |
 |
|
|
|
|
C. Selection of Schedule |
|
|
|
| |
 |
|
|
|
|
D. Dose Escalation Scheme |
|
|
|
| |
 |
|
|
|
|
E. Patient Monitoring |
|
|
|
| |
 |
|
|
|
|
F. Definition of Study Endpoints |
|
|
|
| |
 |
|
|
|
|
V. Phase II Trials |
|
|
|
| |
 |
|
|
|
|
VI. Phase III Trials |
|
|
|
| |
 |
|
|
|
|
VII. New Challenges for Drug Development in Oncology |
|
|
|
| |
 |
|
|
|
|
References |
|
|
|
| |