Pharmacometric Modeling and Simulation for Generic Drugs Evaluation

The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas: 1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes. 2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints. 3. Pharmacometric modeling and simulation for partial AUC (area under the concentration vs. time curve) as bioequivalence criteria. The goal is to develop modeling and simulation tools that will aid FDA in identifying which generic drug products require greater degrees of pharmacokinetic profile similarity in order to assure therapeutic equivalence. Detailed Description: Applicants who wish to apply for more than one subtopic should submit separate proposals for each subtopic as listed below: Subtopic 1: Population pharmacokinetic and pharmacodynamic, d...
Source: Grants.gov - Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding

Related Links:

In conclusion, our meta-analysis showed that there was no statistically significant difference in blood zinc and hair zinc levels between ADHD children and adolescents compared with healthy children and adolescents. PMID: 31704595 [PubMed - as supplied by publisher]
Source: Asian Journal of Psychiatry - Category: Psychiatry Tags: Asian J Psychiatr Source Type: research
Publication date: Available online 10 November 2019Source: Neuroscience &Biobehavioral ReviewsAuthor(s): Alessio Bellato, Iti Arora, Chris Hollis, Madeleine J. GroomAbstractAlthough arousal mechanisms have frequently been found to be atypical in ADHD, these findings usually emerged from indirect behavioural measures which give only a limited understanding of arousal dysregulation in this condition. To assess the hypothesis that functioning of the autonomic nervous system (ANS), one component of arousal, is atypical in ADHD, we carried out a systematic review of the literature on 55 studies investigating electro-dermal,...
Source: Neuroscience and Biobehavioral Reviews - Category: Neuroscience Source Type: research
Attention-Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity and impulsivity. In childhood ADHD has an estimated prevalence rate of 5 –7% (American Psychiatric Association, 2013; Polanczyk, de Lima, Horta, Biederman,&Rohde, 2007; Thomas, Sanders, Doust, Beller,&Glasziou, 2015; Willcutt, 2012); during the transition to adolescence a significant reduction of clinical manifestations is usually observed. Males are more often involved, with a gender ratio of 2:1 in clinical samples and 4:1 in population samples (American Psychiatric Association, 2013;...
Source: Archives of Psychiatric Nursing - Category: Nursing Authors: Source Type: research
In this study, we proposed a dynamical systems perspective to assess how the DMN over time recruits different configurations of network segregation and integration. Specifically, we were interested in configurations for which both intra- and inter-network connections are retained, as opposed to commonly used methods which assess network segregation as a single measure. From resting-state fMRI data, we extracted three different stable configurations of FC patterns for the DMN, namely synergies. We provided evidence supporting our hypothesis that ADHD differs compared to controls, both in terms of recruitment rate and topolo...
Source: NeuroImage - Category: Neuroscience Source Type: research
Publication date: Available online 7 November 2019Source: Neuroscience &Biobehavioral ReviewsAuthor(s): Yan Zeng, Ying Tang, Yan Yue, Wenxing Li, Xia Qiu, Peng Hu, Jun Tang, Huiqing Wang, Xiaoyan Yang, Yi Qu, Dezhi MuAbstractWe conducted a systematic review and meta-analysis to evaluate the association between parental diabetes mellitus and the risk of ADHD in offspring. The PubMed, EMBASE, Cochrane, and Web of Science databases were searched from inception to May 31, 2019. Thirteen observational studies containing 5,052,736 participants were included. Two reviewers independently extracted data and assessed the quality...
Source: Neuroscience and Biobehavioral Reviews - Category: Neuroscience Source Type: research
Few if any experts believe that existing psychiatric diagnostic categories included in the DSM/ICD are actually discrete disease entities. Attention-deficit/hyperactivity disorder (ADHD) is emblematic of the problems in the existing psychiatric classification system. ADHD symptoms reliably cluster into two correlated dimensions in factor analysis. However, children with ADHD vary considerably in their symptom profiles, symptom trajectories, clinical outcomes, and biological and psychological correlates.
Source: Biological Psychiatry - Category: Psychiatry Authors: Tags: Review Source Type: research
While there are a number of drugs to treat Attention Deficit Hyperactivity Disorder (ADHD), they can have some pretty serious side effects. Researchers in Singapore at the country’s Institute of Mental Health (IMH), Duke-NUS (National Universit...
Source: Medgadget - Category: Medical Devices Authors: Tags: Neurology Pediatrics Psychiatry Source Type: blogs
This study aims to analyze the effect of stimulant on processing speed performance and attention indices in children with ASD and ADHD.Methods: Forty children aged 6-18 years diagnosed with ASD who also met the criteria for ADHD were recruited. All children performed a computerized performance test for the assessment of cognitive attention performance three times: twice while they are drug naïve and once an hour after taking a single dose of 10 mg. methylphenidate (MPH). This performance was compared to a group of children diagnosed with 'ADHD only' without ASD.Results: A significant difference (p 
Source: Nordic Journal of Psychiatry - Category: Psychiatry Tags: Nord J Psychiatry Source Type: research
[Neurobehavioral Comorbidities in Pentylenetetrazol-kindled Mice and Role of the α4β2 Nicotinic Acetylcholine Receptor]. Yakugaku Zasshi. 2019;139(11):1397-1402 Authors: Takechi K Abstract Patients with epilepsy are often affected by not only seizures but also a variety of cognitive and psychiatric comorbidities that further impair their quality of life. However, it is unclear whether epilepsy is associated with psychic function. The aim of the present study was to clarify the effects of kindling-induced epileptic seizures on psychic functioning, using behavioral pharmacological tests. Pent...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - Category: Drugs & Pharmacology Authors: Tags: Yakugaku Zasshi Source Type: research
Abstract Over the last decade there has been an increase in the prevalence of autism spectrum disorder (ASD); however, its pathogenic mechanisms remain unclear. To date, no effective drug has been developed to treat the core symptoms of ASD, especially social interaction deficits. Previous studies have mainly focused on the glutamatergic, GABAergic, and serotonergic signaling pathways; however, a growing number of studies have reported abnormalities in the dopaminergic pathway, such as mutations and functional alterations of dopamine-related molecules, in ASD patients. Furthermore, atypical antipsychotic drugs ris...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - Category: Drugs & Pharmacology Authors: Tags: Yakugaku Zasshi Source Type: research
More News: ADHD | Clinical Trials | Funding | Grants | Health | Hyperactivity | Marketing | New Drug Applications | Research | Science | Toxicology