European Medicines Agency ICH Topic E11. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99) online: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population-revision-1-addendum_en.pdf Last accessed 28/08/2024.

European Medicines Agency (EMA) QWPPC. 2013. Guideline on the pharmaceutical development of medicines for pediatric use. https://www.tga.gov.au/sites/default/files/2024-07/Guidelineonpharmaceuticaldevelopmentofmedicinesforpaediatric%20use%20.pdf Last accessed 25/08/2024.

Ethical Considerations for Clinical Investigations of Medical Products Involving Children. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ethical-considerations-clinicalinvestigations-medical-products-involving-children Last accessed 30-08-2024.

Kozarewicz P. Regulatory perspectives on acceptability testing of dosage forms in children. Int J Pharm. 2014;469(2):245–8. https://doi.org/10.1016/j.ijpharm.2014.03.057.

Article  CAS  PubMed  Google Scholar 

Preis M, Breitkreutz J. Pediatric Drug Development and Dosage Form Design. AAPS PharmSciTech. 2017;18(2):239–40. https://doi.org/10.1208/s12249-016-0705-x.

Article  PubMed  Google Scholar 

Van Riet-Nales DA, Kozarewicz P, Aylward B, de Vries R, Egberts TC, Rademaker CM, Schobben AF. Paediatric Drug Development and Formulation Design-a European perspective. AAPS PharmSciTech. 2017;18(2):241–9. https://doi.org/10.1208/s12249-016-0558-3.

Article  CAS  PubMed  Google Scholar 

WHO. Fact sheet. 341. Geneva. Switzerland: World Health Organization; 2010.

Google Scholar 

Batchelor HK, Marriott JF. Formulations for children: problems and solutions. Br J Clin Pharmacol. 2015;79(3):405–18. https://doi.org/10.1111/bcp.12268.

Article  PubMed  PubMed Central  Google Scholar 

Siafaka P, Ipekci E, Caglar EŞ, Ustundag Okur N, Buyukkayhan D. Current status of Pediatric formulations for Chronic and Acute Children’ diseases: applications and future perspectives. Medeni Med J. 2021;36(2):152–62. https://doi.org/10.5222/MMJ.2021.78476.

Article  PubMed  PubMed Central  Google Scholar 

Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, Flanagan T, Kendall R, Tuleu C, European Paediatric Formulation Initiatives EuPFI. Formulation factors affecting acceptability of oral medicines in children. Int J Pharm. 2015;492(1–2):341–3. https://doi.org/10.1016/j.ijpharm.2015.05.013.

Article  CAS  PubMed  Google Scholar 

Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, Flanagan T, Tuleu C. Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs. 2014;74(16):1871–89. https://doi.org/10.1007/s40265-014-0297-2.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Michele TM, Knorr B, Vadas EB, Reiss TF. Safety of chewable tablets for children. J Asthma: Official J Association Care Asthma. 2002;39(5):391–403. https://doi.org/10.1081/jas-120004032.

Article  Google Scholar 

McGuire MR, Mostofa A, Shon J, Frost M, Kim MJ, Li K. Designs of clinical swallowability assessments of solid oral dosage forms in regulatory submissions. Int J Pharm. 2024;659:124229. https://doi.org/10.1016/j.ijpharm.2024.124229.

Article  CAS  PubMed  Google Scholar 

Turner-Bowker DM, Haack A. Patient-focused Drug Development: incorporating clinical outcome assessments into endpoints for Regulatory Decision-Making Guidance for Industry. Food and Drug Administration Staff, and Other Stakeholders; April, 2020.

Yuan G, Design of Children’s Product Packaging Preference Based on Big Data Machine Learning., Wireless Communications and Mobile Computing, vol. 2021, Article ID 8424939, 10 pages, 2021. https://doi.org/10.1155/2021/8424939

Campbell GA, Vallejo E. Primary packaging considerations in developing medicines for children: oral liquid and powder for constitution. J Pharm Sci. 2015;104(1):52–62. https://doi.org/10.1002/jps.24223.

Article  CAS  PubMed  Google Scholar 

Visser JC, Woerdenbag HJ, Hanff LM, Frijlink HW. Personalized Medicine in Pediatrics: the clinical potential of Orodispersible films. AAPS PharmSciTech. 2017;18(2):267–72. https://doi.org/10.1208/s12249-016-0515-1.

Article  CAS  PubMed  Google Scholar 

Zuccari G, Alfei S, Marimpietri D, Iurilli V, Barabino P, Marchitto L. Mini-tablets: a valid strategy to combine efficacy and safety in Pediatrics. Pharmaceuticals (Basel). 2022;15(1):108. https://doi.org/10.3390/ph15010108.

Article  CAS  PubMed  Google Scholar 

Herranz JL, Arteaga R, Adín J, Armijo JA. Conventional and sustained-release valproate in children with newly diagnosed epilepsy: a randomized and crossover study comparing clinical effects, patient preference and pharmacokinetics. Eur J Clin Pharmacol. 2006;62(10):805–15. https://doi.org/10.1007/s00228-006-0175-2.

Article  CAS  PubMed  Google Scholar 

Selvig K, Alme A, Rugstad HE, Aas K, Bjerve KS. Evaluation of a new sustained-release theophylline tablet for children. Acta Paediatr Scand. 1981;70(6):929–33. https://doi.org/10.1111/j.1651-2227.1981.tb06253.x.

Article  CAS  PubMed  Google Scholar 

https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical Last accessed 20/08/2024.

Turner-Bowker DM, An Haack K, Krohe M, Yaworsky A, Vivas N, Kelly M, Chatterjee G, Chaston E, Mann E, Reaney M. Development and content validation of the Pediatric oral Medicines acceptability questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures. J Patient Rep Outcomes. 2020;4(1):80. https://doi.org/10.1186/s41687-020-00246-1.

Article  PubMed  PubMed Central  Google Scholar 

Ranmal SR, O’Brien F, Lopez F, Ruiz F, Orlu M, Tuleu C, Walsh J, Liu F. Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review. Drug Discovery Today. 2018;23(4):830–47. https://doi.org/10.1016/j.drudis.2018.01.038.

Article  PubMed  Google Scholar 

Vallet T, Elhamdaoui O, Berraho A, Cherkaoui LO, Kriouile Y, Mahraoui C, Mouane N, Pense-Lheritier AM, Ruiz F, Bensouda Y. Medicines Acceptability in Hospitalized children: an Ongoing need for age-appropriate formulations. Pharmaceutics. 2020;12(8):766. https://doi.org/10.3390/pharmaceutics12080766.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Venables R, Batchelor H, Hodson J, Stirling H, Marriott J. Determination of formulation factors that affect oral medicines acceptability in a domiciliary paediatric population. Int J Pharm. 2015;480(1–2):55–62. https://doi.org/10.1016/j.ijpharm.2015.01.023.

Article  CAS  PubMed  Google Scholar 

Marriage and divorce data, The Division of Social Statistics, Department of statistcs, Jordan. https://dosweb.dos.gov.jo/population/marriage-and-divorce/

JASP Team. JASP (Version 0.19.0) [Computer software]. 2024. Available at. https://jaspstats.org

Batchelor H, European Paediatric Formulation Initiative (EUPFI). Paediatric biopharmaceutics classification system: current status and future decisions. Int J Pharm. 2014;469(2):251-3. https://doi.org/10.1016/j.ijpharm.2014.02.046. Epub 2014 Mar 3. PMID: 24602991.

Hanning SM, Walker E, Sutcliffe E, Tuleu C, with the London Generation R Young Persons Advisory Group. The rectal route of medicine administration for children: Let’s get to the bottom of it! Eur J Pharm Biopharm. 2020;157:25–7. https://doi.org/10.1016/j.ejpb.2020.09.015.

Article  PubMed  Google Scholar 

Gerrard SE, Walsh J, Bowers N, Salunke S, Hershenson S. Innovations in Pediatric Drug formulations and Administration Technologies for Low Resource settings. Pharmaceutics. 2019;11(10):518. https://doi.org/10.3390/pharmaceutics11100518.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Smith L, Leggett C, Borg C. Administration of medicines to children: a practical guide. Aust Prescr. 2022;45(6):188–92. https://doi.org/10.18773/austprescr.2022.067.

Article  PubMed  PubMed Central  Google Scholar 

Syofyan S, Dachriyanus D, Masrul M, Rasyid R. Children’s perception and belief about Medicines: effectiveness and its autonomy. Open Access Maced J Med Sci. 2019;7(15):2556–62. https://doi.org/10.3889/oamjms.2019.662. PMID: 31666864; PMCID: PMC6814459.

Article  PubMed  PubMed Central  Google Scholar 

Schluterman HM, Linardos CG, Drulia T, Marshall JD, Kearns GL. Evaluating palatability in young children: a mini-review of relevant physiology and assessment techniques. Front Pediatr. 2024;12:1350662. https://doi.org/10.3389/fped.2024.1350662.

Article  PubMed  PubMed Central  Google Scholar 

Mennella JA, Roberts KM, Mathew PS, Reed DR. Children’s perceptions about medicines: individual differences and taste. BMC Pediatr. 2015;15:130. https://doi.org/10.1186/s12887-015-0447-z.

Article  PubMed  PubMed Central  Google Scholar 

Šuleková M, Smrčová M, Hudák A, Heželová M, Fedorova M. Organic Colouring agents in the Pharmaceutical Industry. Folia Vet. 2017;61:32–46.