Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies - Lopez-Navas, Luis; Torrents, Sílvia; Sánchez-Pernaute, Rosario; Vives, Joaquim (Stem cells translational medicine, 2022)
Keywords: Accreditation; Compliance; Concise Reviews; Conformity; FDA approval; Good Manufacturing Practice; Human subjects; Laboratories; Manufacturing; Pharmaceuticals; Product development; Quality management; Quality standards; Regulatory approval; Reproducibility; Stem cells; Supply chains; Tissue engineering; quality compliance; good laboratory practice; product development; advanced therapy medicinal products; preclinical assessment; regulatory guidelines; non-clinical safety