| Id |
Subject |
Object |
Predicate |
Lexical cue |
| T69 |
0-42 |
Sentence |
denotes |
Risk‐based preclinical safety requirements |
| T70 |
43-367 |
Sentence |
denotes |
The global support for drug and vaccine development, including streamlining nonclinical requirements, has allowed candidates, such as severe acute respiratory syndrome coronavirus 2 (SARS‐CoV2) antibodies, to move quickly into the clinic to most efficiently determine if the experimental treatment is effective for patients. |
| T71 |
368-585 |
Sentence |
denotes |
The practice of deferring or eliminating certain preclinical studies while there is a degree of uncertainty in the experimental candidate for specific life‐threatening illnesses with no effective treatment is not new. |
| T72 |
586-734 |
Sentence |
denotes |
ICH S9 Guideline “Nonclinical Evaluation for Anticancer Pharmaceuticals” provides for such regulatory flexibility for advanced oncology indications. |
| T73 |
735-893 |
Sentence |
denotes |
We encourage regulators to apply this approach to other life‐threatening illnesses across therapeutic areas, and to model a global harmonized approach as ICH. |
| T74 |
894-1068 |
Sentence |
denotes |
The benefits to society could be significant—by reducing the need to use animals, modernize drug development, and potentially make new therapies available to patients faster. |
