Jaeschke RR, Sujkowska E, Sowa-Kućma M. Methylphenidate for attention-deficit/hyperactivity disorder in adults: a narrative review. Psychopharmacology. 2021;238(10):2667–91. https://doi.org/10.1007/s00213-021-05946-0.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Childress AC, Komolova M, Sallee FR. An update on the pharmacokinetic considerations in the treatment of ADHD with long-acting methylphenidate and amphetamine formulations. Expert Opin Drug Metab Toxicol. 2019;15(11):937–74. https://doi.org/10.1080/17425255.2019.1675636.

Article  CAS  PubMed  Google Scholar 

Mattingly GW, Carbray JA, Roy P, López FA. Are all ADHD medications created equal? Exploring the differences that enable evening dosing. Postgrad Med. 2024;136(5):475–86. https://doi.org/10.1080/00325481.2024.2370230.

Article  CAS  PubMed  Google Scholar 

Maldonado R. Comparison of the pharmacokinetics and clinical efficacy of new extended-release formulations of methylphenidate. Expert Opin Drug Metab Toxicol. 2013;9(8):1001–14. https://doi.org/10.1517/17425255.2013.786041.

Article  CAS  PubMed  Google Scholar 

Jackson A. Impact of release mechanism on the pharmacokinetic performance of PAUC metrics for three methylphenidate products with complex absorption. Pharm Res. 2014;31(1):173–81. https://doi.org/10.1007/s11095-013-1150-0.

Article  CAS  PubMed  Google Scholar 

USFDA. Product-Specific Guidances on Methylphenidate Hydrochloride Extended release tablet (021121),https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate%20Hydrochloride_draft_Oral%20tab%20ER_RLD%2021121_RC07-18.pdf. Accessed 27 June 2025. 2018.

USFDA. Product-Specific Guidances on Methylphenidate Hydrochloride Extended release capsule (021284),https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021284.pdf. Accessed 27 June 2025. 2020.

EMA. EMA. Product-Specific Guidances on Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg, https://www.ema.europa.eu/en/documents/scientific-guideline/methylphenidate-prolonged-release-tablet-18-mg-27-mg-36-mg-54-mg-modified-release-capsule-5-mg-10-mg-20-mg-30-mg-40-mg-50-mg-60-mg-product-specific-bioequivalence-guidance_en.pdf. Accessed 29 June 2025. 2025.

Ahn JE, French JL. Longitudinal aggregate data model-based meta-analysis with NONMEM: approaches to handling within treatment arm correlation. J Pharmacokinet Pharmacodyn. 2010;37(2):179–201. https://doi.org/10.1007/s10928-010-9152-6.

Article  PubMed  Google Scholar 

Kimko H, Gibiansky E, Gibiansky L, Starr HL, Berwaerts J, Massarella J, et al. Population pharmacodynamic modeling of various extended-release formulations of methylphenidate in children with attention deficit hyperactivity disorder via meta-analysis. J Pharmacokinet Pharmacodyn. 2012;39(2):161–76. https://doi.org/10.1007/s10928-011-9238-9.

Article  CAS  PubMed  Google Scholar 

Jackson AJ, Foehl HC. A simulation study of the comparative performance of partial area under the curve (pAUC) and partial area under the effect curve (pAUEC) metrics in crossover versus replicated crossover bioequivalence studies for Concerta and Ritalin LA. AAPS J. 2022;24(4):80. https://doi.org/10.1208/s12248-022-00726-w.

Article  CAS  PubMed  Google Scholar 

Vincze I, Endrényi L, Tóthfalusi L. Bioequivalence metrics for absorption rates: linearity, specificity, sensitivity. Acta Pharm Hung. 2019;89(1):17–21. https://doi.org/10.33892/aph.2019.89.17-21.

Article  Google Scholar 

Teuscher NS, Adjei A, Findling RL, Greenhill LL, Kupper RJ, Wigal S. Population pharmacokinetics of methylphenidate hydrochloride extended-release multiple-layer beads in pediatric subjects with attention deficit hyperactivity disorder. Drug Des Dev Ther. 2015;9:2767–75. https://doi.org/10.2147/dddt.S83234.

Article  CAS  Google Scholar 

Pfizer. Citizen petition: request for early-exposure bioequivalence criteria for Quillivant XR (methylphenidate HCl) extended-release oral suspension [Internet]. Silver Spring (MD): Food and Drug Administration; Report No.: FDA-2014-P-1269. Available from: https://www.regulations.gov/document/FDA-2017-N-3615-0029. Accessed 27 June 2025. 2014.

Schug B, Beuerle G, Bilensoy E, Cook J, Fernandes E, Haertter S, et al. The global bioequivalence harmonisation initiative (GBHI): report of the sixth international EUFEPS/PQRI conference. Eur J Pharm Sci. 2025;212:107129. https://doi.org/10.1016/j.ejps.2025.107129.

Article  CAS  PubMed  Google Scholar 

Fang L, Uppoor R, Xu M, Sharan S, Zhu H, Tampal N, et al. Use of partial area under the curve in bioavailability or bioequivalence assessments: a regulatory perspective. Clin Pharmacol Ther. 2021;110(4):880–7. https://doi.org/10.1002/cpt.2174.

Article  CAS  PubMed  Google Scholar 

Swanson JM, Wigal SB, Wigal T, Sonuga-Barke E, Greenhill LL, Biederman J, et al. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs study). Pediatrics. 2004;113(3 Pt 1):e206. https://doi.org/10.1542/peds.113.3.e206.

Article  PubMed  Google Scholar 

Jackson A, Chaudhary I. Pharmacokinetic/Pharmacodynamic Model for Aptensio XR® (an Extended-Release Methylphenidate Formulation) in 6–12 year-old Children. J Bioequiv Availab. 2023;15(2):1–9. https://doi.org/10.33892/aph.2019.89.17-21.

Article  Google Scholar 

Stier EM, Davit BM, Chandaroy P, Chen ML, Fourie-Zirkelbach J, Jackson A, et al. Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations. AAPS J. 2012;14(4):925–6. https://doi.org/10.1208/s12248-012-9397-7.

Article  PubMed  PubMed Central  Google Scholar 

Swedish Medical Products Agency. Public Assessment Report Scientific discussion: Methylphenidate STADA (methylphenidate hydrochloride) (SE/H/1909/01–04/DC), https://cima.aemps.es/cima/pdfs/ipe/80849/IPE_80849.pdf. Accessed 29 Jun 2025. 2021.