A Quantitative Comparison Approach for Methylphenidate Drug Regimens in Attention-Deficit/Hyperactivity Disorder Treatment

Soufsaf, Sara; Robaey, Philippe; Bonnefois, Guillaume; Nekka, Fahima; Li, Jun

doi:10.1089/cap.2018.0093

Cited by 5 publications

(5 citation statements)

References 22 publications

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“…We explored additional conditions of variability and sample size through a pop-PK model of extended release MPH. 19 By varying the IIV on absorption parameters and testing a larger sample size, we simulated IIV T = IIV R , IIV T > IIV R , and IIV T < IIV R when the sample size is 40 or 100 subjects. All results concurred with the scenario-based method.…”

Section: Discussionmentioning

confidence: 99%

“…Because the interindividual variability (IIV) is very large for MPH, the dose individualization is especially difficult. 19,20 By adopting TBE, we show how we can effectively establish bioequivalence between various formulations while reducing uncertainty related to substitutability. For an objective evaluation of bioequivalence, we have also used enriched clinical trial data for specific scenarios by incorporating population pharmacokinetic (pop-PK) modeling and simulation in our investigation.…”

Section: What Does This Study Add To Our Knowledge?mentioning

confidence: 99%

“…To explore the impact of IIV on the bioequivalence methods, we used the published MPH pop-PK model to simulate databases that incorporate interindividual and intraindividual variability. 19 Each simulated pair of test and reference formulations is chosen with a random variance of IIV (ω2) listed in Table 2 while the fixed effects and residual variability remained unchanged. Consequently, the 2 R and 2…”

Section: Interindividual Variabilitymentioning

confidence: 99%

“…As a concrete drug example, we show how we can directly apply our proposed approach to methylphenidate (MPH), the main drug for attention deficit hyperactivity disorder. Because the interindividual variability (IIV) is very large for MPH, the dose individualization is especially difficult 19,20 . By adopting TBE, we show how we can effectively establish bioequivalence between various formulations while reducing uncertainty related to substitutability.…”

Section: Introductionmentioning

confidence: 99%

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Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical‐driven balance of population average and variability

Soufsaf

Nekka

2022

CPT Pharmacom & Syst Pharma

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Among the current approaches for the analysis of bioequivalence, the average bioequivalence (ABE) is limited only to the mean bioavailability, whereas the population bioequivalence (PBE) criterion aggregates both mean and variance in a general comparison formula. However, a rational bioequivalence criterion capable of judging specific drug considerations is always still preferred. As an alternative approach, we introduce an aggregate criterion, namely, the trapezoid bioequivalence (TBE), which includes the consideration of both mean and variance of the bioavailability and adapted weighting of a drug's therapeutic properties. We first applied our method to specific simulated scenarios to compare the strengths and weaknesses of current bioequivalence approaches and demonstrate the improvements brought by TBE. As well, the impact of sample size and variability on ABE, PBE, and TBE are assessed using a population pharmacokinetic model of methylphenidate. Our results indicate that TBE inherits the advantages of both ABE and PBE while greatly reducing their inadequacies. Through simulations with population pharmacokinetic models of specific scenarios, we confirm that (1) TBE does not encounter the overly permissiveness issue of PBE, (2) TBE respects the hierarchy to ABE (TBE => ABE), and (3) TBE assesses bioequivalence with a restriction on 2 T − 2 R without an increase to type 2 errors. The clinically inspired simulations demonstrate TBE's superiority in a realistic context and its potential usefulness in practice. Moreover, the parameter choice in TBE may be adapted according to the specific context of a drug's pharmacological and pharmacodynamic properties. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?Average bioequivalence (ABE) and population bioequivalence (PBE) are the current statistical analyses of bioequivalence. ABE does not consider the variability of bioavailability. PBE is an aggregate criterion that considers variability but poses hierarchy problems with ABE.

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Section: Discussionmentioning

confidence: 99%

Section: What Does This Study Add To Our Knowledge?mentioning

confidence: 99%

Section: Interindividual Variabilitymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical‐driven balance of population average and variability

Soufsaf

Nekka

2022

CPT Pharmacom & Syst Pharma

Self Cite

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“…Em contrapartida, as formulações de libertação imediata apresentam maior flexibilidade a nível de toma, além de tendencionalmente apresentarem um custo menor. Deste modo, além das restantes variáveis deve-se ter em atenção a avaliação do custo-benefício das formulações no momento da seleção da formulação (Soufsaf et al, 2019).…”

Section: A Perturbação De Défice De Atenção E Hiperatividade Em Crian...unclassified

A perturbação de défice de atenção e hiperatividade em crianças e adolescentes: revisão bibliográfica

Rodrigues,

Fonseca,

Araújo

et al. 2023

EGITANIA SCENCIA

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A Perturbação de Défice de Atenção e Hiperatividade (PDAH) é um dos distúrbios mentais mais comum em todo o mundo. Tendo em conta as necessidades individuais de cada criança e/ou adolescente é imprescindível compreender esta perturbação na sua caracterização, etiologia e tratamento. A presente revisão da literatura objetivou sistematizar e organizar as melhores evidências científicas sobre esta perturbação, quanto à sua caracterização, etiologia, epidemiologia, diagnóstico e o seu tratamento. Para isso realizou-se uma pesquisa nas bases de dados eletrónicas Scopus, Scielo, Pubmed, Web of Science e Google Scholar, e consultou-se o site do INFARMED. Foram incluídos estudos científicos resultantes da pesquisa com combinações das palavras-chave Perturbação de Défice de Atenção e Hiperatividade (PDAH), etiologia, diagnóstico, subtipos da PDAH, comorbilidades, tratamento não farmacológico e tratamento farmacológico. Foram selecionados estudos científicos entre os anos 2003 e 2021, assim como estudos em língua portuguesa e inglesa. Verificou-se que além da importância de um diagnóstico precoce é importante determinar a presença de comorbilidades com objetivo de não agravar o prognóstico desta perturbação. Os avanços científicos desmistificaram a etiologia da PDAH resultante de fatores relacionados com alimentação, sendo principalmente atribuída à componente genética e desequilíbrios em vários neurotransmissores nas áreas cerebrais que regulam a atenção (como o córtex frontal). No que se refere ao tratamento, verificou-se que é principalmente realizado com medicamentos psicotrópicos, mas revelou-se de extrema importância instituir um tratamento não farmacológico concomitante, de forma a ser mais eficaz e seguro. De um modo geral, concluiu-se que é de extrema importância continuar a realizar estudos de modo a aprimorar os critérios de diagnóstico e as linhas orientadoras de instituição de tratamento farmacológico, com vista ao tratamento personalizado de cada criança ou adolescente.

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An exploratory analysis of the performance of methylphenidate regimens based on a PKPD model of dopamine and norepinephrine transporter occupancy

Soufsaf

Robaey

Nekka

2023

J Pharmacokinet Pharmacodyn

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A Quantitative Comparison Approach for Methylphenidate Drug Regimens in Attention-Deficit/Hyperactivity Disorder Treatment

Cited by 5 publications

References 22 publications

Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical‐driven balance of population average and variability

Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical‐driven balance of population average and variability

A perturbação de défice de atenção e hiperatividade em crianças e adolescentes: revisão bibliográfica

An exploratory analysis of the performance of methylphenidate regimens based on a PKPD model of dopamine and norepinephrine transporter occupancy

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