Biochemical and histological effects of the subchronic treatment with a beer containing Baccharis dracunculifolia in an experimental model of diabetes.

This article reports the development of a beer made with Baccharis dracunculifolia and its application in an experimental model of diabetes. Initially, the production of the beverage was standardized in order to incorporate the plant extract properly. Next, the beer was analyzed by the UHPLC-MS to identify the substances present.

Strengths use and emotional disorder symptom reduction during a transdiagnostic cognitive behavioral therapy: A random-intercept cross-lagged panel model study.

Strengths use, the engagement of positive character traits in everyday contexts, is associated with both positive functioning and symptom reduction. The present study examined longitudinal relationships between strengths use and emotional disorder symptoms (anxiety, stress, and depression) during a randomized clinical trial of the Digital Unified Protocol, a transdiagnostic cognitive behavioral therapy. Participants (N = 120) completed assessments at four major time points during treatment and at 3-month follow-up.

The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.

Assessment of reversibility from nonclinical toxicity findings in animals with potential adverse clinical impact is required during pharmaceutical development, but there is flexibility around how and when this is performed and if recovery animals are necessary. For monoclonal antibodies (mAbs) and in accordance with ICH S6(R1) if inclusion of recovery animals is warranted, this need only occur in one study. Data on study designs for first-in-human (FIH)-enabling and later-development toxicity studies were shared from a recent collaboration between the NC3Rs, EPAA, Netherlands Medicines Evaluation Board (MEB) and 14 pharmaceutical companies.

Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.

To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb development has shown a relatively benign and well-understood safety profile for this class, with most toxicity findings anticipated based on pharmacology. We evaluated whether a 6-month toxicity study is necessary to assess the long-term safety of mAbs.