Literature DB >> 31281980

Generic drug products in paediatrics: Where are the data?

Sílvia M Illamola1, Angela K Birnbaum1, Catherine M Sherwin1,2,3.   

Abstract

Keywords:  bioavailability; bioequivalence; drug regulation; drug utilization; paediatrics

Mesh：

Substances：

Year:  2019        PMID： 31281980      PMCID： PMC6710507          DOI： 10.1111/bcp.14036

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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  17 in total

1.  Pharmacokinetics of orally administered omeprazole in children. International Pediatric Omeprazole Pharmacokinetic Group.

Authors:  T Andersson; E Hassall; P Lundborg; R Shepherd; M Radke; M Marcon; A Dalväg; S Martin; R Behrens; S Koletzko; M Becker; E Drouin; G Göthberg
Journal:  Am J Gastroenterol       Date:  2000-11       Impact factor: 10.864

Review 2.  The ontogeny of human drug-metabolizing enzymes: phase II conjugation enzymes and regulatory mechanisms.

Authors:  D Gail McCarver; Ronald N Hines
Journal:  J Pharmacol Exp Ther       Date:  2002-02       Impact factor: 4.030

Review 3.  Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

Authors:  Teun van Gelder; Steven Gabardi
Journal:  Transpl Int       Date:  2013-02-27       Impact factor: 3.782

4.  Nationwide conversion to generic tacrolimus in pediatric kidney transplant recipients.

Authors:  Derisha Naicker; Peter W Reed; Jane Ronaldson; Tonya Kara; William Wong; Chanel Prestidge
Journal:  Pediatr Nephrol       Date:  2017-06-28       Impact factor: 3.714

Review 5.  Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts.

Authors:  Hannah Batchelor; Terry Ernest; Talia Flanagan; Sandra Klein; Roy Turner; Nikoletta Fotaki; David Storey
Journal:  Int J Pharm       Date:  2016-06-25       Impact factor: 5.875

6.  Claiming desmopressin therapeutic equivalence in children requires pediatric data: a population PKPD analysis.

Authors:  Robin Michelet; Lien Dossche; Charlotte Van Herzeele; Jan Van Bocxlaer; An Vermeulen; Johan Vande Walle
Journal:  Eur J Clin Pharmacol       Date:  2017-12-03       Impact factor: 2.953

Review 7.  Ontogeny of oral drug absorption processes in children.

Authors:  Miriam G Mooij; Barbara A E de Koning; Mark L Huijsman; Saskia N de Wildt
Journal:  Expert Opin Drug Metab Toxicol       Date:  2012-06-11       Impact factor: 4.481

8.  Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric heart transplant recipients.

Authors:  Son Q Duong; Ashwin K Lal; Rujuta Joshi; Brian Feingold; Raman Venkataramanan
Journal:  Pediatr Transplant       Date:  2015-10-25

9.  Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults.

Authors:  Rafaëlla F A L'homme; Tim Dijkema; Adilia Warris; Andre J A M van der Ven; Diana M Gibb; David M Burger
Journal:  J Antimicrob Chemother       Date:  2006-10-28       Impact factor: 5.790

Review 10.  Oral drug absorption in pediatrics: the intestinal wall, its developmental changes and current tools for predictions.

Authors:  Jean-Marie Nicolas; François Bouzom; Chanteux Hugues; Anna-Lena Ungell
Journal:  Biopharm Drug Dispos       Date:  2017-02-06       Impact factor: 1.627
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  1 in total

1.  Generic drug products in paediatrics: Where are the data?

Authors:  Sílvia M Illamola; Angela K Birnbaum; Catherine M Sherwin
Journal:  Br J Clin Pharmacol       Date:  2019-07-07       Impact factor: 4.335
  1 in total

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