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Efficacy and safety of AXS05, a novel, oral, NMDAreceptor antagonist with multimodal activity, in agitation associated with Alzheimers disease: results from ADVANCE1, a phase 2/3, doubleblind, active and placebocontrolled trial: developments in clinical trials and cognitive assessment

In research, this reinforces the importance of research use only labeling and the clear demarcation of its intended use for in-vitro studies.[22][23] Reference List Sutton SVW et al., PDA J Pharm Sci Technol 54, 238-249 (2000) Mooradian AD et al., Am J Ther 4, 333344 (1997) Serno T et al., J Pharm Sci 99, 439-451 (2010) FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) Serno T et al., J Pharm Sci 99, 439451 (2010) Wang W., Int J Pharm 289, 130 (2005) Liu J et al., J Pharm Pharmaceut Sci 3, 234242 (2000) Wang W, Int J Pharm 289, 1-30 (2005) Rosenberg AS., AAPS J 8, E501E507 (2006) Shire SJ et al., Adv Drug Deliv Rev 60, 12511262 (2008) CDC: Injection Safety & Multi-dose Vials (2017) Ryan MJ et al., Am J Health-Syst Pharm 58, 115121 (2001) Khan NA et al., J Pharm Pharmaceut Sci 3, 234242 (2000) Lundstedt-Enkel K et al., J Chromatogr B 877, 17371744 (2009) Kramer A et al., GMS Hyg Infect Control 15, Doc14 (2020) Manning MC et al., Pharm Res 17, 1350-1361 (2000) Mitsuhashi S et al., J Parenter Sci Technol 44, 111115 (1990) Harris RJ., J Pharm Sci 93, 29692979 (2004) WHO Annex 6: Good Manufacturing Practices for Sterile Pharmaceutical Products (2011) Mitsuhashi S et al., J Pharm Sci 93, 29692979 (2004) Sahajwalla C et al., Drug Dev Ind Pharm 39, 927-938 (2013) Gershanik J et al., N Engl J Med 307, 13841388 (1982) LeBel M., Clin Pharmacol Ther 24, 622626 (1978) Bolton S & Bon C., Handbook of Pharmaceutical Statistics (4th ed.) (2010) Strickley RG et al., Pharm Res 21, 201-230 (2004) Peptide storage To ensure peptides remain stable and effective for laboratory use, follow these best practices for storage, tailored to maintain their integrity and prevent degradation, oxidation, and contamination: Short-Term Storage Refrigeration: Store peptides at 4C (39F) if they will be used within days to a few months