Digital research data: from analysis of existing standards to a scientific foundation for a modular metadata schema in nanosafety

Background Assessing the safety of engineered nanomaterials (ENMs) is an interdisciplinary and complex process producing huge amounts of information and data. To make such data and metadata reusable for researchers, manufacturers, and regulatory authorities, there is an urgent need to record and provide this information in a structured, harmonized, and digitized way. Results This study aimed to identify appropriate description standards and quality criteria for the special use in nanosafety. There are many existing standards and guidelines designed for collecting data and metadata, ranging from regulatory guidelines to specific databases. Most of them are incomplete or not specifically designed for ENM research. However, by merging the content of several existing standards and guidelines, a basic catalogue of descriptive information and quality criteria was generated. In an iterative process, our interdisciplinary team identified deficits and added missing information into a comprehensive schema. Subsequently, this overview was externally evaluated by a panel of experts during a workshop. This whole process resulted in a minimum information table (MIT), specifying necessary minimum information to be provided along with experimental results on effects of ENMs in the biological context in a flexible and modular manner. The MIT is divided into six modules: general information, material information, biological model information, exposure information, endpoint read out information and analysis and statistics. These modules are further partitioned into module subdivisions serving to include more detailed information. A comparison with existing ontologies, which also aim to electronically collect data and metadata on nanosafety studies, showed that the newly developed MIT exhibits a higher level of detail compared to those existing schemas, making it more usable to prevent gaps in the communication of information. Conclusion Implementing the requirements of the MIT into e.g., electronic lab notebooks (ELNs) would make the collection of all necessary data and metadata a daily routine and thereby would improve the reproducibility and reusability of experiments. Furthermore, this approach is particularly beneficial regarding the rapidly expanding developments and applications of novel non-animal alternative testing methods.

Telepsychology

Telepsychology, until recently, was slow-moving and half-heartedly acknowledged in the mental health profession. There is increasing scholarly discourse on the digital therapeutic space. This shift to a digital paradigm means re-evaluating the profession's identity. This chapter considers telepsychology in relation to social justice. It highlights access for underserved groups and the digital divide that limits a substantial population from accessing online services. It identifies the need to integrate telepsychology in community psychology interventions, a significant framework to challenge systemic inequalities in mental health. It outlines the inadequacy of the profession to support needs of diversity in the field and considers if telehealth is one way to bring a shift in the homogenous identity of the profession. Telepsychology has the potential to amplify adherence to social justice principles; however, this requires evolved responses on individual, institutional, and systemic levels to bring unconventional but substantial changes in training, research, and regulatory guidelines.

Preanalytical phase for transfusion medicine and blood bank laboratory – tasks to complete

Background: This review describes and evaluates the most relevant preanalytical errors and their impact on subsequent laboratory diagnostics. Quality management for laboratory processes remains extremely important, despite current advancements in information technologies and fully automated routine procedures. Methods: This review is focused on specific preanalytical requirements for the blood bank and transfusion laboratory. Conclusions are done based on literature review. Results: Human errors, or lack of procedures, continue to be the cause of many errors within laboratory processes. The medical laboratory needs an impetus and stipulation to improve processes, to help eliminate errors, and meet regulatory guidelines. Conclusions: General preanalytical rules exist for clinical and research laboratories but differences in laboratory specialty and provided services influence compliance

Marijuana’s Changing Legal Landscape and Its Implications for Adolescent Psychiatrists: A Report from California

Background Objectives: Thirty-three states and the District of Columbia (DC) have enacted some form of legalized cannabis or cannabinoid for medical conditions (MMJ), 11 of them and DC for recreational use. It has become critical for psychiatrists and other mental health professionals working with adolescents to be aware of diversion of marijuana (MJ) to youth and subsequent potential adverse effects in environments with widely different regulations. The experience of two office-based psychiatrists in California (the first state to legalize MMJ) through case presentations and an informal practice review illustrate the role that diverted MMJ plays in the clinical presentation of youth for psychiatric care, highlighting clinical implications and guidelines for treators as states legalize MJ for adult recreational use. Methods: Two child and adolescent psychiatrists practicing in California over the last twenty years report on their experiences working with adolescent patients and their families during the period of legalized MMJ. After a comprehensive literature review, they report their clinical observations and make recommendations for treators of adolescents. Discussion: There is general confusion among adolescents and their parents about MJ and MMJ. There is a lack of clear regulatory guidelines and a need for better clinical training for prescribing physicians. Diversion of MMJ to teens during periods of legalization of medical marijuana is common in states where it has been not legislated or regulated sufficiently to provide effective safeguards. This lax approach is demonstrated by our case reports and clinical review. Similar experiences have been reported elsewhere. Increased problems with diversion are expected as legalization efforts continue. Professionals and their organizations need to become more active in advocating policies to protect youth from potential harm related to cannabis use and abuse and carefully evaluate its use among their teen patients.

Cosmetic Gynecology: Present and Future Perspectives

Postmenopausal women and events like childbirth, and aging may cause structural and functional changes in women genitalia. The arising indications do not only cause psychological distress to women but negatively affect the sexual well-being and deteriorate the quality of their lives. Regenerative/ cosmetic gynecology procedures enable women to treat the functionality issues and modify the physical structure of vagina. This review discusses the latest developments in this field with regards to various kinds of procedures that are available, particularly the use of energy-based devices, and adipose tissue derived stem cells therapy for fat grafting which have revolutionized the regenerative gynecology procedures. These offer non-invasive modalities to treat the conditions like urinary incontinence among others which occur in high prevalence among women. Despite the advancements made in this field, it lacks regulatory guidelines and standardized procedures which imposes one of the biggest challenges of the field. Alongside, we have documented a procedure called Intimacell® which has been standardized for fat grafting procedures in vulvovaginal region.

A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma

A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) system was developed and fully validated for the simultaneous determination of ephedrine and pseudoephedrine in human plasma after oral administration of the herbal prescription Ojeok-san (OJS); 2-phenylethylamine was used as the internal standard (IS). Both compounds presented a linear calibration curve (r2 ≥ 0.99) over a concentration range of 0.2–50 ng/mL. The developed method was fully validated in terms of selectivity, lower limit of quantitation, precision, accuracy, recovery, matrix effect, and stability, according to the regulatory guidelines from the U.S. Food and Drug Administration and the Korea Ministry of Food and Drug Safety. This validated method was successfully applied for the pharmacokinetic assessment of ephedrine and pseudoephedrine in 20 healthy Korean volunteers administered OJS.

Dependence of specific absorption rate and its distribution inside a homogeneous fruit model on frequency, angle of incidence, and wave polarization

Electromagnetic regulatory guidelines prescribed by the international and national organizations are in effect worldwide to protect humans from immediate health effects. For restricting human exposure to electromagnetic radiation in near field, a quantitative term ‘specific absorption rate (SAR) limit’ has been coined and well established in literature. In addition, reference power density limit has also been prescribed in far field for human safety. At the same time, plants and fruits also absorb reasonable amount of electromagnetic energy due to high permittivity and electrical conductivity. Unfortunately, there is not much concern regarding electromagnetic energy absorption in plants and fruits, and no prescribed SAR limit in spite of recent reports in literature. Unlike humans, plants and fruits are of asymmetric shapes and sizes; therefore even at a particular frequency and fixed reference power density, electromagnetic energy absorption rate i.e., SAR in plants and fruits is expected to differ depending upon angle of incidence and wave polarization. To address these issues in detail, a typical bunch of three single layered water apples has been prototyped and exposed to plane wave irradiation at five different frequency bands as per the existing Indian electromagnetic regulatory guidelines. Broadband dielectric properties of water apples have been measured using open ended coaxial probe technique; thereafter, measured dielectric properties have been fed into the designed model. At a particular frequency, reasonable variations in magnitude and position of maximum local point (MLP) SAR, 1 g averaged SAR, and 10 g averaged SAR data have been noted for six different combinations of angle of incidence and wave polarization. This whole course of action is repeated over five different frequency bands. Moreover, variations in observed SAR data are also compared with previously reported variations in SAR data for a multilayer fruit structure. Observations indicate different order of changes in SAR for different fruit structures due to similar combinations of frequency, power density, angle of incidence, and wave polarization. Hence, direct definition of SAR limits for plant and fruit structures should be adopted even in far field in conjunction with reference power density.

Abiraterone Induced Refractory Hypokalemia and Torsades de Pointes in a Patient with Metastatic Castration-Resistant Prostate Carcinoma: A Case Report

Background Abiraterone, an androgen deprivation therapy (ADT), has been used in the treatment of metastatic castration-resistant prostate cancer (mCRPC). It has been associated with increased risks of hypokalemia and cardiac disorders. We report a case of torsades de pointes (TdP) associated with abiraterone use and refractory hypokalemia in a man with mCRPC. Case summary A 78-year-old man with mCRPC presented to the emergency room for generalized weakness. Laboratory results revealed a potassium level of 2.2 mmol/L (3.5-5.0), magnesium level of 2.4 mg/dl (1.6-2.5), and normal kidney and hepatic functions. Initial EKG showed atrial fibrillation with rapid ventricular rate of 106 b.p.m., frequent premature ventricular contractions (PVCs), and a QTc of 634 ms. The patient had multiple episodes of TdP, became pulseless and underwent advanced cardiac life support, including defibrillation. Despite a total of 220 mEq of intravenous potassium chloride, his potassium level only improved to 2.8 mmol/L. He received spironolactone and amiloride to promote urinary potassium reabsorption in addition to hydrocortisone, in an effort to reduce abiraterone’s effect on increasing mineralocorticoid synthesis. Discussion Abiraterone has been widely used in mCRPC since its approval by the FDA in 2011. Regulatory guidelines and standardized close QTc and electrolyte monitoring in patients may help prevent fatal arrhythmias associated with abiraterone.

Development of nanomedicines and nano-similars: recent advances in regulatory landscape

Background: Nanopharmaceuticals serve as emerging forms of modern medicines which include nanomedicines, nanosimilars, nanotheranostics, nanodevices and many more. In last two decades, a large number of nano-based products has reached to the market and are being used clinically. Objectives: Unlike, conventional pharmaceutical products, nanopharmaceuticals behave differently both in vitro and in vivo and therefore, development of their generic versions needs special attention to replicate the similar drug release pattern leading to the identical therapeutic outcome. Further, drug-device combinations and 3D products are latest advancements in precise medicine delivery and development. Methods: The regulatory guidelines for these products are being framed at many stages by various regulatory agencies like USFDA/EMA and still are in infancy at the moment if we look at wider prospective and applications of nanomedicine. Results: For a formulation scientist, it is much needed that well-explained and directive guidelines should be available before leading to the development of the generic versions of these nano-cargos. Conclusion: Here, in this review, we have summarized the silent features of the regulatory perspectives related to the nanotechnology based next generation therapeutics and diagnostics.