References:
1. Provision by health-care professionals of patient-specific preparations for children that are
not available as authorized products – points to consider. Geneva, World Health Organization,
2010 (working document QAS/11.399/Rev. 1).
2. Kearns GL et al. Developmental pharmacology – drug disposition, action and therapy in
infants and children. New England Journal of Medicine, 2003, 349:1157–1167.
3. International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Clinical investigation
of medicinal products in the paediatric population. Implementation: EU, MHLW, FDA.
Adopted by CPMP, July 2000, issued as CPMP/ICH/2711/99; adopted 15 December 2000,
PMSB/ELD Notification No. 1334. Federal Register, 12 April 2000, 65(71): 19777–19781.
4. WHO draft guideline on quality risk management. Geneva, World Health Organization, 2010
(working document QAS/10.376).
5. Pharmaceutical development for multisource (generic) pharmaceutical products. Geneva,
World Health Organization, 2010 (working document QAS/08.251/Rev.1).
6. Committee for Medicinal Products for Human Use (CHMP). Reflection paper: formulations
of choice for the paediatric population. London, EMEA, 2006 (EMEA/CHMP/PEG/196810/2005).
7. Ernest TB et al. Developing paediatric medicines: identifying the needs and recognizing the
challenges. Journal of Pharmacy and Pharmacology, 2007, 59: 1043–1055.
8. Krause J, Breitkreutz J. Improving drug delivery in paediatric medicine. Pharmaceutical
Medicine, 2008, 22: 41–50.
9. Zhao N et al. Tablet splitting: product quality assessment of metoprolol succinate extended
release tablets. International Journal of Pharmaceutics, 2010, 401: 25–31.
10. Allen LV. Dosage form design and development. Clinical Therapeutics, 2008, 30: 2102–2111.
11. Guidelines for registration of fixed-dose combination medicinal products. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations. Thirty-ninth Report. Geneva,
World Health Organization, 2005, Annex 5 (WHO Technical Report Series, No. 929).
12. International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Impurities in new drug
substances. Implementation: EU, MHLW, FDA. Adopted by CPMP, October 2006,
issued as CPMP/ICH/142/95; adopted 4 December 2006, PFSB/ELD Notification No. 1204001.
Federal Register,June 2008.
13. International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Impurities in new drug
products. Implementation: EU, MHLW, FDA. Adopted by CPMP, June 2006, issued as
CPMP/ICH/2738/99; adopted 3 July 2006, PFSB/ELD Notification No. 0703004.
Federal Register, 2003, 68: 64628–64629 with the revised attachment 2.
14. International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Impurities: guideline for residual solvents. Implementation: EU, MHLW, FDA. Core Guideline adopted by
CPMP, September 1997, issued as CPMP/ICH/283/95; Core Guideline adopted March 1998, PMSB/ELD Notification No. 307; Core Guideline published in the Federal Register, 24 December 1997, 62(247):67377; Q3C Tables and list published in Federal Register, 2003, 68: 64352–64353.
15. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the limits of genotoxic impurities. London, 28 June 2006 (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
16. European Medicines Agency. Questions and answers on the “Guideline on the limits of
genotoxic impurities”. London, EMEA, 2010 (EMEA/CHMP/SWP/431994/2007).
17. European Medicines Agency. Guideline on the specification limits for residues of metal
catalysts or metal reagents. London, 21 February 2008 (EMEA/CHMP/SWP/QWP/4446/2000).
18. Siewert M et al. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special
dosage forms. AAPS PharmSciTech, 2003, 4:Article 7 (http://www.aapspharmscitech.org/view.
asp?art=pt040107).
19. Multisource (generic) pharmaceutical products: guidelines on registration requirements to
establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical
Preparations. Fortieth Report. Geneva, World Health Organization 2006, Annex 7
(WHO Technical Report Series, No. 937).
20. Proposal to waive in vivo bioequivalence requirements for WHO Model List of essential
medicines immediate-release, solid dosage forms. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations. Fortieth Report. Geneva, World Health Organization, 2006, Annex 8 (WHO Technical Report Series, No. 937).
21. Breitkreutz J, Boos J. Paediatric and geriatric drug delivery. Expert Opinion on Drug
Delivery, 2007, 4: 37–45.
22. Shehab N et al. Exposure to the pharmaceutical excipients benzyl alcohol and propylene
glycol among critically ill neonates. Pediatric Critical Care Medicine, 2009, 10(2): 256–259.
23. American Academy of Pediatrics. “Inactive” ingredients in pharmaceutical products:
update (subject review). Pediatrics, 1997, 99:268–278 (http:/www.pediatrics.org/cgi/content/full/99/2/268).
24. WHO Technical Report Series on evaluation of certain food additives. List of publications
(http://www.who.int/ipcs/publications/jecfa/reports/en/index.html).
25. Pollock I et al. Survey of colourings and preservatives in drugs. BMJ, 1989, 299: 649–651.
26. Pefferi G, Restani P. The safety of pharmaceutical excipients. Il Farmaco, 2003, 58: 541–550.
27. European Medicines Agency. EMEA Public Statement on antimicrobial preservatives in
ophthalmic preparations for human use. London, EMEA, 2009 (EMEA/622721/2009).
28. Mennella JA, Beauchamp GK. Optimizing oral medications for children. Clinical
Therapeutics, 2008, 30: 2120–2132.
29. Production of zinc tablets and zinc oral solutions: guidelines for programme managers and
pharmaceutical manufacturers, Annex 7. Geneva, World Health Organization, 2007.
30. Cram A et al. Challenges of developing palatable oral paediatric formulations. International
Journal of Pharmaceutics, 2009, 365: 1–3.
31. Committee for Medicinal Products for Human Use. Guideline on the investigation of
medicinal products in the term and preterm neonate. London, European Medicines Agency, 2007 (EMEA/566810/2008).
32. Strickly RG et al. Paediatric drugs – a review of commercially available oral formulations. Journal
of Pharmaceutical Sciences 2007, 97: 1731–1774.
33. Thomson SA et al. Mini-tablets: new modality to deliver medicines to preschool-aged
children. Paediatrics, 2009, 123:e235–e238.
34. The International Pharmacopoeia, 4th ed. First and Second Supplements (available online
and on CD-ROM). Geneva, World Health Organization, 2011 (http://www.who.int/medicines/
publications/pharmacopoeia/overview/en/index.html).
35. Seager H. Drug-delivery products and the zydis fast-dissolving dosage form. Journal of
Pharmacy and Pharmacology, 1998, 50: 375–382.
36. Dolovich M. Influence of inspiratory flow rate, particle size and airway caliber in aerosolized
drug delivery to the lung. Respiratory Care, 2000, 45: 597–608.
Web Sites:
WHO World Health Organization: http://www.who.int
ICH International Conference on Harmonisation: http://www.ich.org
EMA European Medicines Agency: http://www.ema.europa.eu
Development of Paediatric Medicines: points to consider in formulation,
(Annex 5, WHO Technical Report Series 970, 2012)
