Roy A, Geetha RV, Magesh A, Vijayaraghavan R, Ravichandran V. Autoinjector—a smart device for emergency cum personal therapy. Saudi Pharm J. 2021;29(10):1205–15. https://doi.org/10.1016/j.jsps.2021.09.004.

Article  PubMed  PubMed Central  Google Scholar 

Kivitz A, Baret-Cormel L, van Hoogstraten H, Wang S, Parrino J, Xu C, et al. Usability and patient preference phase 3 study of the sarilumab pen in patients with active moderate-to-severe rheumatoid arthritis. Rheumatol Ther. 2018;5(1):231–42. https://doi.org/10.1007/s40744-017-0090-2.

Article  PubMed  Google Scholar 

Kivitz A, Ellis AM, Shende V, Lambert J, Tatla D. Safe and effective subcutaneous self-injection of bimekizumab with safety syringe and auto-injector devices: results from a multicenter, randomized, open-label study in patients with psoriatic arthritis. Patient Prefer Adherence. 2023;17:2451–61. https://doi.org/10.2147/PPA.S427809.

Article  PubMed  PubMed Central  Google Scholar 

Borrás-Blasco J, Gracia-Pérez A, Rosique-Robles JD, Casterá MD, Abad FJ. Acceptability of switching adalimumab from a prefilled syringe to an autoinjection pen. Expert Opin Biol Ther. 2010;10(3):301–7. https://doi.org/10.1517/14712590903530633.

Article  PubMed  Google Scholar 

Borrás-Blasco J, Alcalá García R, Cornejo-Uixeda S, Matellanes-Palacios M, Casterá-Melchor E. Patient preference after switching guselkumab from prefilled syringe to an autoinjection pen in psoriasis and psoriatic arthritis patients. Farm Hosp. 2024;49(3):T160–3. https://doi.org/10.1016/j.farma.2024.10.012.

Article  Google Scholar 

Roth EM, Bujas-Bobanovic M, Louie MJ, Cariou B. Patient and physician perspectives on mode of administration of the PCSK9 monoclonal antibody alirocumab, an injectable medication to lower LDL-C levels. Clin Ther. 2015;37(9):1945–54. https://doi.org/10.1016/j.clinthera.2015.07.008.

Article  PubMed  CAS  Google Scholar 

Dashiell-Aje E, Harding G, Pascoe K, DeVries J, Berry P, Ramachandran S. Patient evaluation of satisfaction and outcomes with an autoinjector for self-administration of subcutaneous belimumab in patients with systemic lupus erythematosus. Patient. 2018;11(1):119–29. https://doi.org/10.1007/s40271-017-0276-2.

Article  PubMed  Google Scholar 

Stauffer VL, Sides R, Lanteri-Minet M, Kielbasa W, Jin Y, Selzler KJ, et al. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence. 2018;12:1785–95. https://doi.org/10.2147/PPA.S170636.

Article  PubMed  PubMed Central  Google Scholar 

Vermeire S, D’heygere F, Nakad A, Franchimont D, Fontaine F, Louis E, et al. Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study. Patient Prefer Adherence. 2018;12:1193–202. https://doi.org/10.2147/PPA.S154181.

Article  PubMed  PubMed Central  Google Scholar 

Tornero Molina J, López Robledillo JC, Casamira RN. Potential benefits of the self-administration of subcutaneous methotrexate with autoinjector devices for patients: a review. Drug Healthc Patient Saf. 2021;13:81–94. https://doi.org/10.2147/DHPS.S290771.

Article  PubMed  PubMed Central  CAS  Google Scholar 

García-Moguel I, Rosado A, Gómez-Cardeñosa A, Gandolfo-Cano M, Robledo Echarren T, Moro Moro MDM, Reaño Martos MDM, Pineda-Pineda R, Valverde-Monge M, Martin-Arriscado Arroba C, Domínguez-Ortega J; AIRE Group. Reliability, satisfaction and effectiveness of benralizumab home self-administration in patients with severe eosinophilic asthma in real-world practice: the auto-benra study. J Asthma Allergy. 2022;15:623–32. https://doi.org/10.2147/JAA.S358738.

Schneider A, Kolrep H, Horn HP, Jordi C, Gierig S, Lange J. Understanding patient preferences for handheld autoinjectors versus wearable large-volume injectors. Expert Opin Drug Deliv. 2023;20(2):273–83. https://doi.org/10.1080/17425247.2022.2162037.

Article  PubMed  Google Scholar 

Tucker ME. Adalimumab autoinjection pen preferred over prefilled syringe. Rheumatology News. 2007. https://www.mdedge.com/rheumatologynews/article/42981/rheumatoid-arthritis/adalimumab-autoinjection-pen-preferred-over. Accessed 14 Mar 2025.

Lambert WJ. Why do the majority of submissions for bridging from a prefilled syringe to an autoinjector include bioequivalence studies in order to demonstrate comparability? AAPS J. 2020;22(3):72. https://doi.org/10.1208/s12248-020-00453-0.

Article  PubMed  Google Scholar 

Bittner B, Schmidt J. Advancing subcutaneous dosing regimens for biotherapeutics: clinical strategies for expedited market access. BioDrugs. 2024;38(1):23–46. https://doi.org/10.1007/s40259-023-00626-1.

Article  PubMed  Google Scholar 

Zhao L, Ji P, Li Z, Roy P, Sahajwalla CG. The antibody drug absorption following subcutaneous or intramuscular administration and its mathematical description by coupling physiologically based absorption process with the conventional compartment pharmacokinetic model. J Clin Pharmacol. 2013;53(3):314–25. https://doi.org/10.1002/jcph.4.

Article  PubMed  CAS  Google Scholar 

Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometr Syst Pharmacol. 2017;6(9):576–88. https://doi.org/10.1002/psp4.12224.

Article  CAS  Google Scholar 

Usach I, Martinez R, Festini T, Peris JE. Subcutaneous injection of drugs: literature review of factors influencing pain sensation at the injection site. Adv Ther. 2019;36:2986–96. https://doi.org/10.1007/s12325-019-01101-6.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Zou P, Wang F, Wang J, Lu Y, Tran D, Seo SK. Impact of injection sites on clinical pharmacokinetics of subcutaneously administered peptides and proteins. J Control Release. 2021;336:310–21. https://doi.org/10.1016/j.jconrel.2021.06.038.

Article  PubMed  CAS  Google Scholar 

Hu P, Wang J, Florian J, Shatzer K, Stevens AM, Gertz J, et al. Systematic review of device parameters and design of studies bridging biologic-device combination products using prefilled syringes and autoinjectors. AAPS J. 2020;22:1–9. https://doi.org/10.1208/s12248-020-0433-8.

Article  CAS  Google Scholar 

Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin. 2010;26(6):1519–30. https://doi.org/10.1185/03007995.2010.481203.

Article  PubMed  CAS  Google Scholar 

Hirsch L, Byron K, Gibney M. Intramuscular risk at insulin injection sites—measurement of the distance from skin to muscle and rationale for shorter-length needles for subcutaneous insulin therapy. Diabetes Technol Ther. 2014;16(12):867–73. https://doi.org/10.1089/dia.2014.0111.

Article  PubMed  CAS  Google Scholar 

Omoigui S, Adewumi PA, Do Y, Elenes G. Bevel design and not needle length determines the pain experience in patients receiving injections. J Pain. 2006;7(8):608–9. https://doi.org/10.1016/j.jpain.2006.01.453.

Article  PubMed  Google Scholar 

Hofman PL, Lawton SA, Peart JM, Holt JA, Jefferies CA, Robinson E, et al. An angled insertion technique using 6-mm needles markedly reduces the risk of intramuscular injections in children and adolescents. Diabet Med. 2007;24(12):1400–5. https://doi.org/10.1111/j.1464-5491.2007.02272.x.

Article  PubMed  CAS  Google Scholar 

Arendt-Nielsen L, Egekvist H, Bjerring P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res. 2006;23(1–2):37–43. https://doi.org/10.1080/08990220600700925.

Article  PubMed  Google Scholar 

Zhong X, Mitra H, Veilleux JC, Simmons E, Shi GH, Ardekani AM. The role of liquid rheological properties on the injection process of a spring-driven autoinjector. Int J Pharm. 2022;628:122296. https://doi.org/10.1016/j.ijpharm.2022.122296.

Article  PubMed  CAS  Google Scholar 

Schwartz S, Hassman D, Shelmet J, Sievers R, Weinstein R, Liang J, et al. A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge × 12.7 mm needle in obese patients with diabetes mellitus. Clin Ther. 2004;26(10):1663–78. https://doi.org/10.1016/j.clinthera.2004.10.007.

Article  PubMed  Google Scholar 

Tinkey K, Alla S, Xiang N. Nonenteral pain management. Otolaryngol Clin North Am. 2020;53(5):853–63. https://doi.org/10.1016/j.otc.2020.05.014.

Article  PubMed  Google Scholar 

Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol. 2007;1(5):725–9. https://doi.org/10.1177/193229680700100517.

Article  PubMed  PubMed Central  Google Scholar 

Thuer T, Birkhaeuer L, Reilly D. Development of an advanced injection time model for an autoinjector. Med