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The National Institutes of Health and the Best Pharmaceuticals for Children Act.
Zajicek A. Zajicek A. Paediatr Drugs. 2009;11(1):45-7. doi: 10.2165/0148581-200911010-00015. Paediatr Drugs. 2009. PMID: 19127953
Challenges encountered include a paucity of investigators who are trained in pediatric clinical pharmacology; inadequate knowledge of the mechanisms of drug action in a growing child; and lack of pediatric formulations....
Challenges encountered include a paucity of investigators who are trained in pediatric clinical pharmacology; inadequate knowledge of …
Inclusion of pregnant and breastfeeding women in research - efforts and initiatives.
Illamola SM, Bucci-Rechtweg C, Costantine MM, Tsilou E, Sherwin CM, Zajicek A. Illamola SM, et al. Among authors: zajicek a. Br J Clin Pharmacol. 2018 Feb;84(2):215-222. doi: 10.1111/bcp.13438. Epub 2017 Oct 22. Br J Clin Pharmacol. 2018. PMID: 28925019 Free PMC article. Review.
This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. ...This paper …
This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, …
Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?
Ren Z, Zajicek A. Ren Z, et al. Among authors: zajicek a. Semin Perinatol. 2015 Nov;39(7):530-1. doi: 10.1053/j.semperi.2015.08.006. Epub 2015 Oct 9. Semin Perinatol. 2015. PMID: 26455383 Free PMC article. Review.
Drug studies in newborns: a therapeutic imperative.
Giacoia GP, Taylor-Zapata P, Zajicek A. Giacoia GP, et al. Among authors: zajicek a. Clin Perinatol. 2012 Mar;39(1):11-23. doi: 10.1016/j.clp.2011.12.016. Epub 2012 Jan 21. Clin Perinatol. 2012. PMID: 22341533 Review.
The factors that prevent the demonstration of efficacy and safety in the newborn are discussed and a change in the current approach for neonatal drug studies is suggested....
The factors that prevent the demonstration of efficacy and safety in the newborn are discussed and a change in the current approach f …
We don't know what we don't study: the case for research on medication effects in pregnancy.
Parisi MA, Spong CY, Zajicek A, Guttmacher AE. Parisi MA, et al. Among authors: zajicek a. Am J Med Genet C Semin Med Genet. 2011 Aug 15;157C(3):247-50. doi: 10.1002/ajmg.c.30309. Epub 2011 Jul 15. Am J Med Genet C Semin Med Genet. 2011. PMID: 21766436 Free PMC article.
Although the first trimester represents a particularly vulnerable period of organogenesis, exposures during other gestational time periods may also be associated with deleterious outcomes. ...Although this is a start, there is a critical need for further rese …
Although the first trimester represents a particularly vulnerable period of organogenesis, exposures during other gestational time pe …
Gaps in knowledge in treating pregnant women.
Mattison D, Zajicek A. Mattison D, et al. Among authors: zajicek a. Gend Med. 2006 Sep;3(3):169-82. doi: 10.1016/s1550-8579(06)80205-6. Gend Med. 2006. PMID: 17081950 Review.
Because studies are often undertaken without knowledge of the pharmacokinetics of a drug, efficacy is difficult to assess in pregnant women. ...A substantial increase in the clearance of drugs eliminated by renal mechanisms also has been noted. A significant …
Because studies are often undertaken without knowledge of the pharmacokinetics of a drug, efficacy is difficult to assess in pregnant …
Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.
Mulugeta YL, Zajicek A, Barrett J, Sachs HC, McCune S, Sinha V, Yao L. Mulugeta YL, et al. Among authors: zajicek a. Pediatr Clin North Am. 2017 Dec;64(6):1185-1196. doi: 10.1016/j.pcl.2017.08.015. Pediatr Clin North Am. 2017. PMID: 29173779 Free PMC article. Review.
However, a high percentage of pediatric trials do not meet their primary efficacy endpoint. Delays in initiating completing pediatric studies persist. ...
However, a high percentage of pediatric trials do not meet their primary efficacy endpoint. Delays in initiating completing pediatric …
Obstetric clinical pharmacology: coming of age.
Zajicek A, Giacoia GP. Zajicek A, et al. Clin Pharmacol Ther. 2007 Apr;81(4):481-2. doi: 10.1038/sj.clpt.6100136. Clin Pharmacol Ther. 2007. PMID: 17375105
This network serves in part as a proof-of-concept platform, to demonstrate that clinical investigations can be performed in pregnant women....
This network serves in part as a proof-of-concept platform, to demonstrate that clinical investigations can be performed in pregnant …
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.
Wang J, Johnson T, Sahin L, Tassinari MS, Anderson PO, Baker TE, Bucci-Rechtweg C, Burckart GJ, Chambers CD, Hale TW, Johnson-Lyles D, Nelson RM, Nguyen C, Pica-Branco D, Ren Z, Sachs H, Sauberan J, Zajicek A, Ito S, Yao LP. Wang J, et al. Among authors: zajicek a. Clin Pharmacol Ther. 2017 Jun;101(6):736-744. doi: 10.1002/cpt.676. Clin Pharmacol Ther. 2017. PMID: 28510297 Free PMC article. Review.
This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the colle …
This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss t …
Meeting the demand for pediatric clinical trials.
Connor EM, Smoyer WE, Davis JM, Zajicek A, Ulrich L, Purucker M, Hirschfeld S. Connor EM, et al. Among authors: zajicek a. Sci Transl Med. 2014 Mar 12;6(227):227fs11. doi: 10.1126/scitranslmed.3008043. Sci Transl Med. 2014. PMID: 24622511 Free PMC article.
High-quality, cost-effective pediatric clinical trials require a robust research and regulatory infrastructure and a properly trained workforce....
High-quality, cost-effective pediatric clinical trials require a robust research and regulatory infrastructure and a properly …
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