共 50 条
- [1] The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials British Journal of Cancer, 2007, 97 : 577 - 581
- [3] EMEA guidelines for trials in osteoporosis: design implications NETHERLANDS JOURNAL OF MEDICINE, 2002, 60 (08): : 310 - 314
- [4] First-in-human clinical trials: Comparison of EMEA and FDA guidelines MEDICINA CLINICA, 2009, 132 (01): : 30 - 34
- [6] EMEA guidelines on biosimilars and their clinical implications KIDNEY & BLOOD PRESSURE RESEARCH, 2007, 30 : 13 - 17