Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering.

Well-characterized and scalable downstream processes for the purification of biologics are extremely demanding for delivering quality therapeutics to patients at a reasonable price. Erythropoietin (EPO) is a blockbuster biologic with diverse clinical applications, but its application is limited to financially well-off societies due to its high price. The high price of EPO is associated with the technical difficulties related to the purification challenge to obtain qualified products with a cost-effective defined process.

Causal mediation analysis: From simple to more robust strategies for estimation of marginal natural (in)direct effects.

This paper aims to provide practitioners of causal mediation analysis with a better understanding of estimation options. We take as inputs two familiar strategies (weighting and model-based prediction) and a simple way of combining them (weighted models), and show how a range of estimators can be generated, with different modeling requirements and robustness properties. The primary goal is to help build intuitive appreciation for robust estimation that is conducive to sound practice.

Effectiveness and feasibility of the workout on wheels internet intervention (WOWii) for individuals with spinal cord injury: a randomized controlled trial.

Study Design: Randomized-controlled trial (RCT) with immediate intervention (IMM) and wait-list control (WLC) groups; WLC participants received the intervention during delivery to subsequent cohorts.

Objectives: Investigate the effectiveness and feasibility of a virtually-delivered exercise intervention.

Setting: Home and community.

Assumptions Not Often Assessed or Satisfied in Published Mediation Analyses in Psychology and Psychiatry.

Mediation analysis aims to investigate the mechanisms of action behind the effects of interventions or treatments. Given the history and common use of mediation in mental health research, we conducted this review to understand how mediation analysis is implemented in psychology and psychiatry and whether analyses adhere to, address, or justify the key underlying assumptions of their approaches. All articles (n = 206) were from top academic psychiatry or psychology journals in the PsycInfo database and were published in English from 2013 to 2018.