메뉴 건너뛰기




Volumn 14, Issue 3, 2012, Pages 519-522

Biopharmaceutic planning in pediatric drug development

Author keywords

bioavailability; bioequivalence; biopharmaceutics; formulations; pediatric

Indexed keywords

AGE; ARTICLE; BIOPHARMACEUTICAL PLANNING; CLINICAL STUDY; DRUG DEVELOPMENT; DRUG FORMULATION; DRUG MARKETING; DRUG RESEARCH; INFORMATION RETRIEVAL; PEDIATRIC DRUG DEVELOPMENT; PEDIATRICS; PHARMACEUTICS; PROGRAM DEVELOPMENT; RISK ASSESSMENT; STRATEGIC PLANNING;

EID: 84862761437     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9364-3     Document Type: Article
Times cited : (20)

References (11)
  • 1
    • 84862754367 scopus 로고    scopus 로고
    • Accessedon:17Jan2012
    • Pediatric Research Equity Act of 2007, Title IV. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/UCM049870.pdf. Accessed on: 17 Jan 2012.
    • Pediatric Research Equity Act of 2007, Title IV
  • 2
    • 84862753638 scopus 로고    scopus 로고
    • Accessedon17Jan2012
    • Best Pharmaceuticals for Children Act of 2007, Title V. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/UCM049870.pdf. Accessed on 17 Jan 2012.
    • Best Pharmaceuticals for Children Act of 2007, Title v
  • 3
    • 84862753637 scopus 로고    scopus 로고
    • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 12, 2006, on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004 Accessedon17Jan2012
    • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 12, 2006, on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg-2006-1901/reg-2006-1901-en. pdf. Accessed on 17 Jan 2012.
  • 4
    • 33747835599 scopus 로고    scopus 로고
    • Differences in absorption, distribution, metabolism and excretion of xenobiotics between the pediatric and adult populations
    • 10.1517/17425255.1.3.447
    • MS Benedetti R Whomsley EL Baltes 2005 Differences in absorption, distribution, metabolism and excretion of xenobiotics between the pediatric and adult populations Expert Opin Drug Metab Toxicol 1 3 447 471 10.1517/17425255.1.3.447
    • (2005) Expert Opin Drug Metab Toxicol , vol.1 , Issue.3 , pp. 447-471
    • Benedetti, M.S.1    Whomsley, R.2    Baltes, E.L.3
  • 6
    • 55549143695 scopus 로고    scopus 로고
    • Intestinal metabolism and transport of drugs in children: The effects of age and disease
    • 18607262 10.1097/MPG.0b013e31816a8cca 1:CAS:528:DC%2BD1cXot1yls7c%3D
    • TN Johnson M Thomson 2008 Intestinal metabolism and transport of drugs in children: the effects of age and disease J Pediatr Gastroenterol Nutr 47 3 10 18607262 10.1097/MPG.0b013e31816a8cca 1:CAS:528:DC%2BD1cXot1yls7c%3D
    • (2008) J Pediatr Gastroenterol Nutr , vol.47 , pp. 3-10
    • Johnson, T.N.1    Thomson, M.2
  • 7
    • 80054953755 scopus 로고    scopus 로고
    • Ethical considerations in conducting pediatric research. pediatric clinical pharmacology
    • 21882114 10.1007/978-3-642-20195-0-11
    • M Roth-Cline J Gerson P Bright CS Lee RM Nelson 2011 Ethical considerations in conducting pediatric research. pediatric clinical pharmacology Handb Exp Pharmacol 205 Part 2 219 244 21882114 10.1007/978-3-642-20195-0-11
    • (2011) Handb Exp Pharmacol , vol.205 , Issue.PART 2 , pp. 219-244
    • Roth-Cline, M.1    Gerson, J.2    Bright, P.3    Lee, C.S.4    Nelson, R.M.5
  • 8
    • 38049184592 scopus 로고    scopus 로고
    • Bioequivalence approaches for highly variable drugs and drug products
    • 17891552 10.1007/s11095-007-9434-x 1:CAS:528:DC%2BD1cXkslSlsg%3D%3D
    • SH Haidar B Davit ML Chen D Conner L Lee QH Li, et al. 2008 Bioequivalence approaches for highly variable drugs and drug products Pharm Res 25 237 241 17891552 10.1007/s11095-007-9434-x 1:CAS:528:DC%2BD1cXkslSlsg%3D%3D
    • (2008) Pharm Res , vol.25 , pp. 237-241
    • Haidar, S.H.1    Davit, B.2    Chen, M.L.3    Conner, D.4    Lee, L.5    Li, Q.H.6
  • 9
    • 77957727096 scopus 로고    scopus 로고
    • Impact of biopharmaceutics classification system-based biowaivers
    • 10.1021/mp1001747 1:CAS:528:DC%2BC3cXhtFWrurjN
    • JA Cook BM Davit JE Polli 2010 Impact of biopharmaceutics classification system-based biowaivers Mol Pharm 7 1539 1544 10.1021/mp1001747 1:CAS:528:DC%2BC3cXhtFWrurjN
    • (2010) Mol Pharm , vol.7 , pp. 1539-1544
    • Cook, J.A.1    Davit, B.M.2    Polli, J.E.3
  • 10
    • 53849107899 scopus 로고    scopus 로고
    • When will a drug formulation pass or fail bioequivalence criteria? Experience from 1,200 studies
    • Abstract R6193
    • Tanguay M, Potvin D, Haddad J, Lavigne J, Marier JF, DiMarco M, et al. When will a drug formulation pass or fail bioequivalence criteria? Experience from 1,200 studies. AAPS Pharm Sci. 2002;4(S1). Abstract R6193.
    • (2002) AAPS Pharm Sci. , vol.4 , Issue.1 S
    • Tanguay, M.1    Potvin, D.2    Haddad, J.3    Lavigne, J.4    Marier, J.F.5    Dimarco, M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.