BACKGROUND AND PURPOSE We evaluated the concordance of results from two sets of nonclinical cardiovascular safety studies on pitolisant. EXPERIMENTAL APPROACH Nonclinical studies envisaged both in the International Conference on Harmonization (ICH) S7B guideline and Comprehensive in vitro Pro-arrhythmia Assay (CiPA) initiative were undertaken. The CiPA initiative included in vitro ion channel...

Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex p...

OBJECTIVE To determine if primary nocturnal enuresis (PNE) is accompanied by significant behavioral comorbidity. DESIGN A survey design using a standardized behavioral rating scale. SETTING Behavioral pediatric clinics in the Midwest. PARTICIPANTS Subjects with PNE (n=92) were selected from 122 consecutive referrals for enuresis. Criteria included age 5 years or older, PNE status, and wet...

The International Federation of Societies of Toxicologic Pathologists (IFSTP) proposes a common global framework for training future toxicologic pathologists who will support regulatory-type nonclinical toxicology studies. Trainees optimally should undertake a scientific curriculum of at least 5 years at an accredited institution leading to a clinical degree (veterinary medicine or medicine). T...

OBJECTIVE To determine the range and frequency of experiences, clinical and nonclinical roles, training, work expectations, and career plans of practicing pediatric hospitalists. DESIGN Mail survey study of a national sample of 530 pediatric hospitalists of whom 67% (N = 338) were from teaching hospitals, 71% (N = 374) were from children's hospitals, 43% (N = 230) were from freestanding child...

Studies of social phobia in the eating disorders have demonstrated high comorbidity with both anorexia and bulimia nervosa. This study examined levels of social anxiety across different types of eating disorders, and determined the association of such anxiety with specific forms of emotional regulation. One hundred fourteen females who met DSM-IV criteria for an eating disorder and a comparison...

Saccharomyces cerevisiae strains of clinical and nonclinical origin were compared by pulse field gel electrophoresis. Complete separation between strains of clinical origin and food strains by their chromosome length polymorphism was not obtained even though there was a tendency for the clinical and food strains to cluster separately. All the investigated strains, except for one food strain, we...

The International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) is a global project establishing diagnostic criteria and nomenclature for both proliferative and nonproliferative changes in laboratory animals. Nonrodent working groups (NRWGs) have been established for the dog, nonhuman primate, minipig, and the rabbit. The Global Editorial and Steering Committee (GESC) oversees ...

BACKGROUND Mobile device-based ecological momentary assessment (mobile-EMA) is increasingly used to collect participants' data in real-time and in context. Although EMA offers methodological advantages, these advantages can be diminished by participant noncompliance. However, evidence on how well participants comply with mobile-EMA protocols and how study design factors associated with particip...

This article provides a high-level overview of the drug development process small-molecule drugs for analytical chemist. Emphasis is given to nonclinical and roles technical organization in driving new project from toxicology studies product registration. A case study career path separation scientist used illustrate diversified an chemist development.