The Need for Modeling and Simulation to Design Clinical Investigations in Children

scientific article published on 01 September 2010

The Need for Modeling and Simulation to Design Clinical Investigations in Children is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1177/0091270010376968
P953full work available at URLhttp://www.jclinpharm.org/cgi/content/abstract/50/9/121S
https://accp1.onlinelibrary.wiley.com/doi/pdf/10.1177/0091270010376968
https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1177%2F0091270010376968
P698PubMed publication ID20881225

P50authorSteven E KernQ98164169
P2093author name stringPravin R. Jadhav
P2860cites workMechanistic basis of using body size and maturation to predict clearance in humansQ37404427
Pediatric antihypertensive trial failures: analysis of end points and dose rangeQ37436147
Drug therapy in pediatrics: a developing fieldQ37488352
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Candesartan cilexetil effectively reduces blood pressure in hypertensive childrenQ42663516
Carvedilol therapy in pediatric patients with congestive heart failure: a study investigating clinical and pharmacokinetic parameters.Q44012404
The Pediatric Randomized Carvedilol Trial in Children with Heart Failure: rationale and designQ44135194
Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.Q45927030
Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method.Q46156878
Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 yearsQ46193460
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.Q47569147
The importance of randomized controlled trials in pediatric cardiologyQ81234779
Proposals for model-based paediatric medicinal development within the current European Union regulatory frameworkQ28749999
Fluconazole dosing for the prevention or treatment of invasive candidiasis in young infantsQ30435365
Population pharmacokinetics of fluconazole in young infantsQ30439710
Pharmacokinetics And Pharmacodynamics Of Fenoldopam Mesylate For Blood Pressure Control In Pediatric PatientsQ33374155
The FDA critical path initiative and its influence on new drug development.Q34734622
Population pharmacokinetics and dose simulation of carvedilol in paediatric patients with congestive heart failure.Q36536474
Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safetyQ36565063
Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.Q36720907
Improving pediatric dosing through pediatric initiatives: what we have learnedQ37098241
Quantitative disease, drug, and trial modelsQ37292641
Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescentsQ37379360
P433issue9 Suppl
P407language of work or nameEnglishQ1860
P921main subjectmodelling biological systemsQ4299308
P304page(s)121S-129S
P577publication date2010-09-01
P1433published inThe Journal of Clinical PharmacologyQ7743562
P1476titleThe need for modeling and simulation to design clinical investigations in children
The Need for Modeling and Simulation to Design Clinical Investigations in Children
P478volume50

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cites work (P2860)
Q34554486Bridging the gap: a review of dose investigations in paediatric investigation plans
Q37666706Drug Development for Pediatric Populations: Regulatory Aspects
Q36322918Effect of Kidney Function on Drug Kinetics and Dosing in Neonates, Infants, and Children
Q33658786Lack of Clinical Pharmacokinetic Studies to Optimize the Treatment of Neglected Tropical Diseases: A Systematic Review
Q38016332Physiologically based pharmacokinetic (PBPK) modeling in children
Q41975490Physiologically based pharmacokinetic models in the prediction of oral drug exposure over the entire pediatric age range-sotalol as a model drug

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