Bridging studies in support of oral pediatric formulation development

International Journal of Pharmaceutics

Volumn 457, Issue 1, 2013, Pages 323-326

  Ricci, Benedicte M ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Bioequivalence; Enabling formulation; Formulation bridging; Pediatric formulation; Relative bioavailability

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG MARKETING; DRUG SAFETY; HUMAN; PATIENT COMPLIANCE; PEDIATRICS; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; RELATIVE BIOAVAILABILITY;

BIOEQUIVALENCE; ENABLING FORMULATION; FORMULATION BRIDGING; PEDIATRIC FORMULATION; RELATIVE BIOAVAILABILITY;

ADMINISTRATION, ORAL; CHEMISTRY, PHARMACEUTICAL; CHILD; HUMANS; PHARMACEUTICAL PREPARATIONS;

EID: 84888329568     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.07.074     Document Type: Article

References (21)

1. G.L. Amidon, and C.R. Walgreen Jr. Is there a need for a pediatric BCS? Meeting Minutes of Best Pharmaceuticals for Children Act Pediatric Formulations Initiative Workshop, November 1-2, 2011 Bolger Center Potomac, MD 2011 Available at http://bpca.nichd.nih.gov/collaborativeefforts/upload/PFI-Workshop-11-1-2-11.pdf (last accessed 06.25.13)
2. M.L. Chen, A.B. Straughn, N. Sadrieh, M. Meyer, P.J. Faustino, A.B. Ciavarella, B. Meibohm, C.R. Yates, and A.S. Hussain A modern view of excipient effects on bioequivalence: case study of sorbitol Pharm. Res. 24 2007 73 80 (Pubitemid 44902572)
3. J. Dunne, W.J. Rodriguez, M.D. Murphy, B.N. Beasley, G.J. Burckart, J.D. Filie, L.L. Lewis, H.C. Sachs, P.H. Sheridan, P. Starke, and L.P. Yao Extrapolation of adult data and other data in pediatric drug-development programs Pediatrics 128 2011 e1242 e1249
4. EMA CPMP/ICH/2711/99. ICH E11 Clinical Investigation of medicinal products in the paediatric population, note for guidance on clinical investigation of medicinal products in the paediatric population 2001 Available at http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002926.pdf (last accessed 06.25.13).
5. EMA EMEA/CHMP/EWP/147013/2004. Guideline on the Role of Pharmacokinetics in the development of medicinal products in the Paediatric Population 2006 Available at http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003066.pdf (last accessed 06.25.13)
6. EMA CPMP/EWP/QWP/1401/98 Rev. 1/Corr**. Guideline on the investigation of bioequivalence 2010 Available at http://www.emea.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/01/WC500070039.pdf (last accessed 06.25.13)
7. EMA EMA/CHMP/QWP/805880/2012 Rev. 1. Draft Guideline on pharmaceutical development of medicines for paediatric use 2013 Available at http://nvkfb.nl/download/2013/Guideline%20on%20pharmaceutical%20development%20of%20medicines%20for%20paediatric%20use.pdf (last accessed 06.25.13)
8. EMA EMA/618604/2008 Rev. 7. Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party 2013 Available at http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002963.pdf (last accessed 06.25.13)
9. FDA Center for Drug Evaluation and Research (CDER) Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation 1995 Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070636.pdf (last accessed 06.25.13)
10. FDA Center for Drug Evaluation and Research (CDER) Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation 1997 Available at http://www.fda.gov/downloads/Drugs/Guidances/UCM070640.pdf (last accessed 06.25.13)
11. FDA Center for Drug Evaluation and Research (CDER) Application 020766 Orlistat Clinical Pharmacology and Biopharmaceutics Review(s), Part 1 1999 Available at http://www.accessdata.fda.gov/drugsatfda-docs/nda/99/020766a-xenical-clinphrmr-P1.pdf (last accessed 06.25.13)
12. FDA Center for Drug Evaluation and Research (CDER) Guidance for Industry Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System 2000 Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf (last accessed 06.25.13)
13. FDA Center for Drug Evaluation and Research (CDER) Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies 2002 Available at http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126833.pdf (last accessed 06.25.13)
14. FDA Center for Drug Evaluation and Research (CDER) Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations 2003 Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf (last accessed 06.25.13)
15. FDA Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Guidance for Industry Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications 2003 Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf (last accessed 06.25.13)
16. E. Gupta, D.M. Barends, E. Yamashita, K.A. Lentz, A.M. Harmsze, V.P. Shah, J.B. Dressman, and R.A. Lipper Review of global regulations concerning biowaivers for immediate release solid oral dosage forms Eur. J. Pharm. Sci. 29 2006 315 324 (Pubitemid 44602408)
17. Health Canada Guidance document Conduct and Analysis of Comparative Bioavailability Studies 2012 Available at http://www.hc-sc.gc.ca/dhp-mps/alt-formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd-cbs-ebc-ld-eng.pdf (last accessed 06.25.13)
18. Health Canada Guidance document Comparative Bioavailability Standards: Formulations Used for Systemic Effects 2012 Available at http://www.hc-sc.gc.ca/dhp-mps/alt-formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd-standards-ld-normes-eng.pdf (last accessed 06.25.13)
19. G.L. Kearns, S.M. Abdel-Rahman, S.W. Alander, D.L. Blowey, J.S. Leeder, and R.E. Kauffman Developmental pharmacology - drug disposition, action, and therapy in infants and children N. Engl. J. Med. 349 2003 1157 1167 (Pubitemid 37122329)
20. R. Panakanti, and A.S. Narang Impact of excipient interactions on drug bioavailability from solid dosage forms Pharm. Res. 29 2012 2639 2659
21. B. Reigner, B.M. Ricci, and X. Liogier D'Ardhuy Role of clinical pharmacology in the development of paediatric clinical development plans K. Rose, J.N. van den Anker, Guide to Paediatric Drug Development and Clinical Research 2010 Karger Basel 51 59