References
- Services USDoHaH, Administration FaD. Guidance for Industry E9 statistical principles for clinical trials; 1998. Available from: https://www.fda.gov/media/71336/download.
- Stanulović V, Hodolic M, Mitsikostas DD, et al. Drug tolerability: how much ambiguity can be tolerated? A systematic review of the assessment of tolerability in clinical studies. Br J Clin Pharmacol. 2022;88(2):1–2.
- Crowley J, Thaçi D, Joly P, et al. Long-term safety and tolerability of apremilast in patients with psoriasis: pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017;77(2):310–317.e1.
- Administration USFD. Step 3: clinical research; 2018. Available from: https://www.fda.gov/patients/drugdevelopment-process/step-3-clinical-research.