A Randomized, Double-Blind, Phase III Study in India for Comparing Efficacy, Safety, and PK of ZRC-3277 (Pertuzumab Biosimilar) With Perjeta® in Patients With HER2-Positive Metastatic Breast Cancer.

Introduction: To evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) with Perjeta® (pertuzumab) in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Patients And Methods: This phase III, multicenter, double-blind study across 38 sites in India randomized (1:1) patients with HER2-positive MBC in either the ZRC-3277 or Perjeta® group. Both groups also received trastuzumab and docetaxel.

Leveraging AI and Machine Learning in Six-Sigma Documentation for Pharmaceutical Quality Assurance.

The pharmaceutical industry must maintain stringent quality assurance standards to ensure product safety and regulatory compliance. A key component of the well-known Six Sigma methodology for process improvement and quality control is precise and comprehensive documentation. However, there are a number of significant issues with traditional documentation procedures, including as slowness, human error, and difficulties with regulatory standards.

Volatile capture technology in sustainable anaesthetic practice: a narrative review.

Anaesthetic practice contributes to climate change. Volatile capture technology, typically based on adsorption to a carbon- or silica-based substrate, has the potential to mitigate some of the harmful effects of using halogenated hydrocarbons. Anaesthetists have a professional responsibility to use anaesthetic agents which offer the greatest safety and clinical benefit with the lowest financial cost and environmental impacts.

A mixed-methods analysis of the climate impact, acceptability, feasibility and cost of switching from single-use pulp to reusable plastic trays in a large NHS trust.

A large, multi-site NHS trust piloted switching from single-use pulp to reusable plastic trays for use in clinical care. This mixed-methods analysis combines quantitative cost-effectiveness and greenhouse gas (GHG) emissions calculations with a stakeholder analysis and user survey to not only ascertain the cost and climate implications of this intervention, but to also better understand the use of trays across the trust to improve staff buy-in and, ultimately, the feasibility and success of the policy. We show that the plastic trays are both more cost-effective and climate friendly compared with the pulp trays, even using an annual replacement rate of 50% (higher than our anticipated rate of 5%), and that staff and key stakeholders would support the policy.