Analysis of unknown (unlabeled/mislabeled) drug products for active pharmaceutical ingredients and related substances by an international mail facility satellite laboratory equipped with rapid screening devices.

Two chemists employed a three-device rapid screening "toolkit" consisting of a handheld Raman spectrometer, transportable mass spectrometer, and portable Fourier transform infrared (FT-IR) spectrometer at an international mail facility (IMF) satellite laboratory to examine unknown (unlabeled/mislabeled) products for the presence of active pharmaceutical ingredients (APIs). Phase I of this project previously demonstrated that this toolkit was the most effective collection of instruments for identifying APIs in product types collected at IMFs during a nationwide mail blitz and Phase II of this project previously demonstrated that results generated using the toolkit during a satellite laboratory pilot program were as reliable as those generated by a full-service library when two or more of these instruments identify an API. This study (Phase III) described the results of the satellite laboratory toolkit during production mode and encompassed the period ranging from June 2021 through December 2022.

The influence of loss to follow-up in autism screening research: Taking stock and moving forward.

Background: How best to improve the early detection of autism spectrum disorder (ASD) is the subject of significant controversy. Some argue that universal ASD screeners are highly accurate, whereas others argue that evidence for this claim is insufficient. Relatedly, there is no clear consensus as to the optimal role of screening for making referral decisions for evaluation and treatment.

Verbal Responsiveness in Parents of Toddlers With and Without Autism During a Home Observation.

This study examined patterns of verbal responsiveness in parents of toddlers (M = 20 months) later identified with autism (n = 121), developmental delay (n = 46), or typical development (n = 44) during an hourlong home observation. Parent verbal responsiveness (PVR) was compared using MANOVA across groups and by child expressive language phase. Multiple regression analyses controlling for child age and maternal education were employed to examine the extent to which PVR predicted variance in concurrent child social communication and prospective language skills.

The earlier the better: An RCT of treatment timing effects for toddlers on the autism spectrum.

Behavioral interventions that incorporate naturalistic, developmental strategies have been shown to improve outcomes for young children who receive an autism spectrum disorder (ASD) diagnosis. Although there is broad consensus that children on the spectrum should begin supports as soon as possible, the empirical evidence for this is relatively limited and little is known about the optimal age to start autism-specific interventions. Our team conducted a randomized controlled trial (RCT) to test the effects of starting intervention at different ages, using the Early Social Interaction (ESI) model, a parent-implemented intervention for toddlers on the spectrum.

Characterizing difficulties with emotion regulation in toddlers with autism spectrum disorder.

Background: Difficulties with emotion regulation (ER) underlie emotional/behavioral challenges and co-occurring psychiatric symptoms in autism spectrum disorder (ASD), yet very little is known about the early development of emotion dysregulation. The present study aimed to identify differences in positive and negative emotional reactivity and regulation strategies in toddlers with and without ASD.

Method: Nine tasks from the (Lab-TAB) were completed with 37 toddlers with and without ASD (22-28 months).

Rapid screening of 2-benzylbenzimidazole nitazene analogs in suspect counterfeit tablets using Raman, SERS, DART-TD-MS, and FT-IR.

Developing methods to rapidly screen for novel synthetic 2-benzylbenzimidazole opioids, also known as nitazenes, has become increasingly important due to their high potency. These compounds have potency comparable or exceeding that of fentanyl by up to 10 times and have been implicated in approximately 5% of all drug overdose deaths in the United States in 2021. This paper details the authenticity determination of suspect tablets and the identification of three nitazene analogs (N-pyrrolidino etonitazene, isotonitazene, and etodesnitazene) in suspect tablets seized at a mail facility using Raman and surface-enhanced Raman scattering (SERS) with handheld devices, portable Fourier transform infrared spectrometer (FT-IR), and a direct analysis in real-time ambient ionization coupled to a thermal desorption unit and a mass spectrometer (DART-TD-MS).

Rapid detection of active pharmaceutical ingredients in drug products collected at an international mail facility by a satellite laboratory using a "toolkit" consisting of a handheld Raman spectrometer, portable mass spectrometer and portable FT-IR spectrometer.

A satellite laboratory "toolkit" consisting of a handheld Raman spectrometer, portable direct analysis in real-time mass spectrometer (DART-MS) and portable Fourier transform infrared (FT-IR) spectrometer was employed to examine 926 pharmaceutical, unknown and dietary supplement products collected at an international mail facility (IMF) for the presence of declared and undeclared active pharmaceutical ingredients (APIs) over the course of 68 working days. The toolkit successfully identified over 650 APIs, including over 200 unique APIs, using two or more devices. The performance of each individual device, and toolkit as a whole, were evaluated on all products and a subset of the products was forwarded to full-service laboratories for confirmatory analysis to determine false positive and false negative rates of the toolkit.

Coordinated social communication in toddlers with and without autism spectrum disorder during a home observation.

Background & Aims: Social communication and language skills have been found to be important predictors of long-term outcomes in individuals with autism spectrum disorder (ASD). However, the development of coordinated social communication (i.e.

A rapid method for analysis of non-equilibrated Sr/Y in infant formula.

A rapid analytical method for quantifying Sr in infant formula prior to secular equilibrium is presented. The approach is dependent on the use of two separations of Sr from Y, with the first providing an Y ingrowth start point and the second providing an Y ingrowth end point. Data were obtained at activity concentrations of approximately 6 Bq/kg and 160 Bq/kg, the latter of which is representative of the US Food and Drug Administration (FDA) Derived Intervention Levels (DIL).

Early social communication development in infants with autism spectrum disorder.

Social-communication differences are a robust and defining feature of autism spectrum disorder (ASD) but identifying early points of divergence in infancy has been a challenge. The current study examines social communication in 9- to 12-month-old infants who develop ASD (N = 30; 23% female; 70% white) compared to typically developing (TD) infants (N = 94, 38% female; 88% white). Results demonstrate that infants later diagnosed with ASD were already exhibiting fewer social-communication skills using eye gaze, facial expression, gestures, and sounds at 9 months (effect size: 0.

Systematic Review: Recommendations for Rehabilitation in ASD and ID From Clinical Practice Guidelines.

Objective: To identify and summarize clinical practice guidelines for autism spectrum disorder (ASD) and intellectual disability (ID) for the Package of Interventions for Rehabilitation for the World Health Organization (WHO).

Data Sources: Academic databases, Google Scholar, guideline databases, and professional society websites were searched using the general criteria "ASD/ID" AND "rehabilitation" AND "guideline," restricted to English-only guidelines.

Study Selection: Work group members independently screened titles and abstracts (1952 ASD; 1027 ID) and excluded articles if not (1) a guideline; (2) about rehabilitation; (3) published since 2008; or (4) about ASD/ID.

Rethinking autism spectrum disorder assessment for children during COVID-19 and beyond.

The COVID-19 pandemic has posed unique challenges for families and caregivers, as well as for autism-focused clinicians, who are faced with providing a thorough and accurate evaluation of children's specific needs and diagnoses in the absence of in-person assessment tools. The shift to telehealth assessments has challenged clinicians to reconsider approaches and assumptions that underlie the diagnostic assessment process, and to adopt new ways of individualizing standard assessments according to family and child needs. Mandates for physical distancing have uncovered deficiencies in diagnostic practices for suspected autism and have illuminated biases that have posed obstacles preventing children and families from receiving the services that they truly need.

Evaluating Teacher Language Within General and Special Education Classrooms Serving Elementary Students with Autism.

This study examined how teachers and paraprofessionals in 126 kindergarten-second grade general and special education classrooms talked with their 194 students with autism, and further, how individual student characteristics in language, autism symptoms, and social abilities influenced this talk. Using systematic observational methods and factor analysis, we identified a unidimensional model of teacher language for general and special education classrooms yet observed differences between the settings, with more language observed in special education classrooms-much of which included directives and close-ended questions. Students' receptive vocabulary explained a significant amount of variance in teacher language beyond its shared covariance with social impairment and problem behavior in general education classrooms but was non-significant within special education classrooms.

Early Observation of Red Flags in 12-Month-Old Infant Siblings Later Diagnosed With Autism Spectrum Disorder.

Purpose Valid and reliable screening tools are needed to improve early detection and optimize developmental outcomes for toddlers at risk for autism spectrum disorder (ASD). The current study aimed to evaluate the utility of the Systematic Observation of Red Flags (SORF) for ASD at 12 months of age in a sample of high-risk infant siblings of children with ASD. Method As part of a prospective, longitudinal study, we examined the sensitivity and specificity of the SORF at 12 months for predicting a diagnosis of ASD at 24 months in a sample of 122 infants, 31 of whom were diagnosed with ASD.

Rate of Communicative Gestures and Developmental Outcomes in Toddlers With and Without Autism Spectrum Disorder During a Home Observation.

Purpose Most toddlers with autism spectrum disorder and other developmental delays receive early intervention at home and may not participate in a clinic-based communication evaluation. However, there is limited research that has prospectively examined communication in very young children with and without autism in a home-based setting. This study used granular observational coding to document the communicative acts performed by toddlers with autism, developmental delay, and typical development in the home environment.

Measures of Early Social Communication and Vocabulary Production to Predict Language Outcomes at Two and Three Years in Late-Talking Toddlers.

Background: Late talkers are a heterogeneous group of toddlers and reliable predictors of persistent language delay have been elusive. The purpose of this study was to determine the extent to which early social communication and vocabulary production predicted variance in language outcomes at 2 and 3 years of age.

Methods: Participants were 408 typically developing and late-talking toddlers who completed the Communication and Symbolic Behavior Scales Caregiver Questionnaire and Behavior Sample (CSBS CQ and CSBS BS) at a mean of 20 months, the Language Development Survey (LDS) at a mean of 24 months, and the Mullen Scales of Early Learning (MSEL) at a mean of 25 months.

Factors associated with enrollment into a clinical trial of caregiver-implemented intervention for infants at risk for autism spectrum disorder.

Early intervention helps to address developmental delays in young children with autism spectrum disorder. Yet, research suggests there are barriers to enrollment into research studies that test the effectiveness of these interventions for infants at risk. This study identifies family characteristics that were associated with agreement to enroll in a clinical trial of early intervention for 12-month-old infants at risk for autism spectrum disorder.

Practice guideline: Treatment for insomnia and disrupted sleep behavior in children and adolescents with autism spectrum disorder: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

Objective: To review pharmacologic and nonpharmacologic strategies for treating sleep disturbances in children and adolescents with autism spectrum disorder (ASD) and to develop recommendations for addressing sleep disturbance in this population.

Methods: The guideline panel followed the American Academy of Neurology 2011 guideline development process, as amended. The systematic review included studies through December 2017.

Simple methods for calculating activity of a parent-progeny system.

Based on the original work of Rutherford (Radio-activity, 1905) and Bateman (Proc Camb Philos Soc 15:423-427, 1910), the authors designed two schemes consisting of explicit equations as simple methods for accurately obtaining activity of Sr and Y before they reach secular equilibrium. Application of the methods to the Sr/Y system where Sr and Y are not in equilibrium will substantially reduce the time needed for determining activity of Sr because neither sequential measurements of Sr or Y (up to about 2 weeks) nor waiting for Sr and Y to reach equilibrium (more than 3 weeks) will be needed. We also implemented the explicit equations for decay/ingrowth correction of progeny's activity and applied them to the Zr/Nb system.

Screening for autism spectrum disorder in a naturalistic home setting using the systematic observation of red flags (SORF) at 18-24 months.

The purpose of this study was to examine the utility of the Systematic Observation of Red Flags (SORF; Dow et al., 2016) as a level 2 screener for autism spectrum disorder (ASD) in toddlers during a naturalistic video-recorded home observation. Psychometric properties of the SORF were examined in a sample of 228 toddlers-84 with ASD, 82 with developmental delay (DD), and 62 with typical development (TD).