scholarly journals Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a c4c expert group White paper.

2021 ◽  
Author(s):  
Jennifer Walsh ◽  
Daniel Schaufelberger ◽  
Sonia Lurian ◽  
Sandra Klein ◽  
Hannah Batchelor ◽  
...  
Keyword(s):  
Decision Making ◽  
Age Groups ◽  
White Paper ◽  
Formulation Development ◽  
Effective Age ◽  
New Chemical Entities ◽  
Dosing Regimens ◽  
Post Marketing ◽  
Age Appropriate ◽  
Paediatric Formulation

Improved global access to novel age-appropriate formulations for paediatric subsets, either of new chemical entities or existing drugs, is a priority to ensure that medicines meet the needs of these patients. However, despite regulatory incentives, the introduction to the market of paediatric formulations still lags behind adult products. This is mainly caused by additional complexities associated with the development of acceptable age-appropriate paediatric medicines. This position paper proposes the use of a paediatric Quality Target Product Profile (pQTPP) as an efficient tool to facilitate early planning and decision making during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs. Essential key attributes of a paediatric formulation are suggested and described. Moreover, greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products. Acceptability testing should be a secondary endpoint in paediatric clinical trials to ensure post-marketing adherence is not compromised by a lack of acceptability. Not knowing the indications and the related age groups and potential dosing regimens early enough is still a major hurdle for efficient paediatric formulation development; however the proposed pQTPP could be a valuable collaborative tool for planning and decision making to expedite paediatric product development.

scholarly journals Paediatric Formulation: Design and Development

2020 ◽  
Vol 21 (19) ◽  
pp. 7118
Author(s):  
Antonio Lopalco ◽  
Nunzio Denora
Keyword(s):  
Drug Delivery ◽  
Patient Population ◽  
State Of The Art ◽  
Original Research ◽  
Special Issue ◽  
Formulation Development ◽  
Design And Development ◽  
Formulation Design ◽  
Age Appropriate ◽  
Paediatric Formulation

The development of medicines designed for children can be challenging since this distinct patient population requires specific needs. A formulation designed for paediatric patients must consider the following aspects: patient population variability; dose flexibility; route of administration; patient compliance; drug and excipient tolerability. The purpose of this Special Issue entitled “Paediatric Formulation: Design and Development” is to provide an update on both state-of-the-art methodology and operational challenges in the design and development of paediatric formulations. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients. This editorial, briefly, summarizes the objects of nine original research and review papers published in this Special Issue.

scholarly journals Validation of a French Version of the Career Decision-Making Difficulties Questionnaire: Relationships With Self-Esteem and Self-Efficacy

2021 ◽  
pp. 089484532110099
Author(s):  
Jérôme Rossier ◽  
Shékina Rochat ◽  
Laurent Sovet ◽  
Jean-Luc Bernaud
Keyword(s):  
Decision Making ◽  
Career Counseling ◽  
Self Efficacy ◽  
Age Groups ◽  
Career Decision ◽  
Self Esteem ◽  
Career Decision Making ◽  
Student Sample ◽  
French Version ◽  
The Relationship

The aim of this study was to validate the French version of the Career Decision-Making Difficulties Questionnaire (CDDQ) and to assess its measurement invariance across gender, age groups, countries, and student versus career counseling samples. We also examined the sensitivity of this instrument to discriminate a career counseling population from a general student sample. Third, we studied the relationship between career decision-making difficulties, career decision-making self-efficacy, and self-esteem in a sample of 1,748 French and French-speaking Swiss participants. A confirmatory factor analysis confirmed the overall hierarchical structure of the CDDQ. Multigroup analysis indicated that the level of invariance across groups almost always reached configural, metric, and scalar invariance. Differences between countries were very small, whereas differences between the general population and career counseling subsamples were much larger. Both self-esteem and self-efficacy significantly predicted career decision-making difficulties. Moreover, as expected, self-efficacy partially mediated the relationship between self-esteem and career decision-making difficulties.

scholarly journals Drivers’ Age and Automated Vehicle Explanations

2021 ◽  
Vol 13 (4) ◽  
pp. 1948
Author(s):  
Qiaoning Zhang ◽  
Xi Jessie Yang ◽  
Lionel P. Robert
Keyword(s):  
Decision Making ◽  
Middle Age ◽  
Age Groups ◽  
Design Experiment ◽  
Mixed Design ◽  
Automated Vehicles ◽  
Automated Vehicle ◽  
Automated Decision Making

Automated vehicles (AV) have the potential to benefit our society. Providing explanations is one approach to facilitating AV trust by decreasing uncertainty about automated decision-making. However, it is not clear whether explanations are equally beneficial for drivers across age groups in terms of trust and anxiety. To examine this, we conducted a mixed-design experiment with 40 participants divided into three age groups (i.e., younger, middle-age, and older). Participants were presented with: (1) no explanation, or (2) explanation given before or (3) after the AV took action, or (4) explanation along with a request for permission to take action. Results highlight both commonalities and differences between age groups. These results have important implications in designing AV explanations and promoting trust.

scholarly journals Eye Placement Bias Is Remarkably Robust

i-Perception ◽  
2021 ◽  
Vol 12 (3) ◽  
pp. 204166952110175
Author(s):  
Kirsten Smith ◽  
Vera Kempe ◽  
Lara Wood
Keyword(s):  
Decision Making ◽  
Motor Skill ◽  
Age Groups ◽  
Systematic Bias ◽  
Decision Making Processes ◽  
Drawing Ability ◽  
Potential Confound

When drawing faces, people show a systematic bias of placing the eyes higher up the head than they are placed in reality. This study investigated the development of this phenomenon while removing the potential confound of drawing ability. Participants ( N = 124) in three age groups (3–5 yo, 10–11 yo, and adults) reconstructed two foam faces: one from observation and one from memory. The high eye placement bias was remarkably robust with mean eye placement in every condition significantly higher than the original faces. The same bias was not shown for mouth placement. Eye placement was highest for the youngest participants and for the memory conditions. The results suggest that an eye placement bias is not caused by the motor skill demands required for drawing and lend evidence to the suggestion that an eye placement bias is caused by perceptual and decision-making processes.

Sex-Role Specialization in a Transforming Market: Empirical Evidence from Vietnamese Middle-Class Households

2011 ◽  
Vol 32 (1) ◽  
pp. 61-73 ◽  
Author(s):  
Elfriede Penz ◽  
Erich Kirchler
Keyword(s):  
Decision Making ◽  
Middle Class ◽  
Sex Role ◽  
Age Groups ◽  
Household Consumption ◽  
Household Decision ◽  
Role Changes ◽  
Consumption Decisions ◽  
Middle Class Families ◽  
Role Specialization

Vietnam is undergoing a rapid transformation to a more prosperous society. This article analyzes household decision making in a transforming economy that has undergone modification of the traditional view of the family, from being an autonomous unit to an object of state policy. This is relevant because policy interventions shape household consumption through gender equality programs and thus have an impact on sex-role specialization. The aim of this study is to advance understanding of Vietnamese household consumption decisions and spouses’ current influence patterns by investigating sex-role specialization in Vietnamese middle-class families’ decision making. Overall, no significant sex-role changes were observed. It seems that traditional Vietnamese sex-role specialization does not (yet) differ among age groups. Instead, traditional sex-role segmentation remains predominant across all investigated age groups. While economic and consumption habits change rapidly, middle-class families appear to preserve their traditional influence patterns in purchase decisions.

scholarly journals Effects of practice on visuo-spatial attention in a wayfinding task

2021 ◽  
Author(s):  
Mai Geisen ◽  
Kyungwan Kim ◽  
Stefanie Klatt ◽  
Otmar Bock
Keyword(s):  
Decision Making ◽  
Spatial Attention ◽  
Older Persons ◽  
Recall Test ◽  
Age Groups ◽  
Attentional Focus ◽  
Gaze Direction ◽  
Fixation Time ◽  
Dynamic Changes ◽  
Virtual City

AbstractSeveral studies have evaluated the distribution of visuo-spatial attention in a wayfinding task, using gaze direction as an indicator for the locus of attention. We extended that work by evaluating how visuo-spatial attention is modified by wayfinding practice. Young and older participants followed prescribed routes through a virtual city on six trials. Each trial was followed by a route recall test, where participants saw screenshots of intersections encountered, and had to indicate which way to proceed. Behavioral and gaze data were registered in those tests. Wayfinding accuracy increased from trial to trial, more so in young than in older persons. Total gaze time, mean fixation time, and the vertical scatter of fixations decreased from trial to trial, similarly in young and older persons. The horizontal scatter of fixations did not differ between trials and age groups. The incidence of fixations on the subsequently chosen side also did not differ between trials, but it increased in older age. We interpret these findings as evidence that as wayfinding practice increased, participants gradually narrowed their attentional focus to the most relevant screenshot area, processed information within this focus more efficiently, reduced the total time in which attention dwelled on the rejected side of the screenshot, but maintained the total time on the chosen side. These dynamic changes of visuo-spatial attention were comparable in young and older participants. However, it appears that decision-making differed between age groups: older persons’ attention dwelled longer on the chosen side before they made their choice.

scholarly journals REVIEW ARTICLE: SOLUBILITY ENHANCEMENT BY SOLID DISPERSION

2017 ◽  
Vol 9 (3) ◽  
pp. 15
Author(s):  
A. N. Patil ◽  
D. M. Shinkar ◽  
R. B. Saudagar
Keyword(s):  
Solid Dispersion ◽  
Aqueous Solubility ◽  
Water Soluble ◽  
Full Potential ◽  
Drug Selection ◽  
Formulation Development ◽  
Poorly Water Soluble Drugs ◽  
New Chemical Entities ◽  
Water Soluble Drugs ◽  
Poorly Water Soluble

Enhancement of solubility, dissolution rate and bioavailability of the drug is a very challenging task in drug development, nearly 40% of the new chemical entities currently being discovered are poorly water soluble drugs. The solubility behaviour of the drugs remains one of the most challenging aspects in formulation development. This results in important products not reaching the market or not achieving their full potential. Solid dispersion is one of the techniques adopted for the formulation of such drugs and various methods are used for the preparation of solid dispersion. Solid dispersion is generally prepared with a drug which is having poor aqueous solubility and hydrophilic carrier. This article review various methods and concept of solid dispersion, criteria for drug selection, advantage and disadvantage, characterization, and application.

scholarly journals Population Pharmacokinetics of the Antimalarial Amodiaquine: a Pooled Analysis To Optimize Dosing

2018 ◽  
Vol 62 (10) ◽  
Author(s):  
Ali Mohamed Ali ◽  
Melissa A. Penny ◽  
Thomas A. Smith ◽  
Lesley Workman ◽  
Philip Sasi ◽  
...  
Keyword(s):  
Age Groups ◽  
Parent Drug ◽  
Hemoglobin Concentration ◽  
Pooled Analysis ◽  
Drug Formulation ◽  
Pharmacokinetic Parameters ◽  
Mixed Effects Modeling ◽  
Dosing Regimens ◽  
Disease Effect ◽  
Disposition Model

ABSTRACTAmodiaquine plus artesunate is the recommended antimalarial treatment in many countries where malaria is endemic. However, pediatric doses are largely based on a linear extrapolation from adult doses. We pooled data from previously published studies on the pharmacokinetics of amodiaquine, to optimize the dose across all age groups. Adults and children with uncomplicated malaria received daily weight-based doses of amodiaquine or artesunate-amodiaquine over 3 days. Plasma concentration-time profiles for both the parent drug and the metabolite were characterized using nonlinear mixed-effects modeling. Amodiaquine pharmacokinetics were adequately described by a two-compartment disposition model, with first-order elimination leading to the formation of desethylamodiaquine, which was best described by a three-compartment disposition model. Body size and age were the main covariates affecting amodiaquine clearance. After adjusting for the effect of weight, clearance rates for amodiaquine and desethylamodiaquine reached 50% of adult maturation at 2.8 months (95% confidence interval [CI], 1.5 to 3.7 months) and 3.9 months (95% CI, 2.6 to 5.3 months) after birth, assuming that the baby was born at term. Bioavailability was 22.4% (95% CI, 15.6 to 31.9%) lower at the start of treatment than during convalescence, which suggests a malaria disease effect. Neither the drug formulation nor the hemoglobin concentration had an effect on any pharmacokinetic parameters. Results from simulations showed that current manufacturer dosing recommendations resulted in low desethylamodiaquine exposure in patients weighing 8 kg, 15 to 17 kg, 33 to 35 kg, and >62 kg compared to that in a typical 50-kg patient. We propose possible optimized dosing regimens to achieve similar drug exposures among all age groups, which require further validation.

scholarly journals From big data to bedside decision-making: the case for AdverseEvents

2013 ◽  
Vol 3 (1) ◽  
pp. 3
Author(s):  
Giuseppe Biondi Zoccai ◽  
Elena Cavarretta ◽  
Giacomo Frati
Keyword(s):  
Decision Making ◽  
Clinical Evidence ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Ease Of Use ◽  
Antithrombotic Agent ◽  
Post Marketing ◽  
The Individual ◽  
User Friendly ◽  
Based Medicine

<p>Evidence-based medicine has gained mainstream popularity, but it requires a delicate balance between clinical evidence, physician skills, patient preferences, and costs. Facing the individual patient, even a simple decision such as which antithrombotic agent should be prescribed becomes complex. There are several reasons for this conundrum, but one of the foremost is the limited external validity of pivotal randomized trials, with their extremely restrictive selection criteria. Post-marketing reporting of adverse events is a very useful and democratic means to appraise the risk-benefit profile, but to date such reports were not organized or available. The development of the Food and Drug Administration (FDA) venue for such task, the FDA Adverse Event Reporting System (FAERS) has substantially improved data collection. However, analysis of this extensive relational database remains complex for most but few companies or agencies. AdverseEvents is a novel online platform enabling updated and user-friendly inquiry of FAERS. Given its ease of use, flexibility and comprehensiveness, it is likely going to improve decision making for healthcare authorities and practitioners, as well as patients. This is clearly testified by the precise and informative comparative analysis that can be performed with AdverseEvents on novel antithrombotic agents.</p>

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