Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 46

1 GXP refers to what three regulatory concepts?

2 Repurposing of a drug is one approach to drug development. True or False

3 A drug being used in a Phase I study must meet all cGMP requirements according to FDA. True or False

4 Post approval prescribing of drug products is governed by state and local officials. True or False

5 ICH E6(R2) Is a regulatory requirement in the United States. True or False