Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 74

1 1 ICH. Website link for the international council for harmonization of technical requirements for pharmaceuticals for human use (ICH), https://www.ich.org/home.html (accessed 27 January 2020)

2 2 FDA (December 2017). Best practices for communication between IND sponsors and FDA during drug development. https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/best‐practices‐communication‐between‐ind‐sponsors‐and‐fda‐during‐drug‐development (accessed 27 January 2020)

3 3 Bargaje, C. (2011). Good documentation practice in clinical research. Perspectives in Clinical Research 2 (2): 59–63. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121265/?report=printable (accessed 27 January 2020).