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Research Insights

The Research Insights section focuses on the latest breakthroughs in medicine and science, as well as the laboratory works around the world. Research insights directly from these labs add tremendous value to our readers.

A Simple And Sensitive Method To Analyze Genotoxic Impurity Hydrazine In Pharmaceutical Materials

Hydrazine NH is a genotoxic impurity that must be tightly controlled at low ppm levels during pharmaceutical development However due to its unique physical and chemical properties

New Developments For Antibody-drug Conjugate-based Therapeutic Approaches

Abstract The clinical success of Adcetris brentuximab vedotin and Kadcyla adotrastuzumab emtansine has sparked clinical development of novel ADCs These powerful anticancer agents are designed to allow specific targeting of highly potent cytotoxic agents to tumor cells while sparing healthy tissues Despite the use of tumorspecific antibodies

Near infra red spectroscopy as a multivariate process analytical tool for predicting pharmaceutical co-crystal concentration

In this study the application of nearinfrared NIR spectroscopy for predicting the concentration of two pharmaceutical cocrystals namely ibuprofen nicotinamide IBUNIC and carbamazepine nicotinamide

Assessment of cognitive safety in clinical drug development

Abstract Cognitive impairment is increasingly recognised as an important potential adverse effect of medication However many drug development programmes do not incorporate sensitive cognitive measurements Here we review the rationale for cognitive safety assessment and explain several basic methodological principles for measuring cognition during...

Increasing Patient Involvement In Drug Development

To ensure the creation of treatments that maximize value at the lowest cost all aspects of the health care system need to align with patient needs and preferences Despite growing efforts

Regulatory Approval Of Pharmaceuticals Without A Randomised Controlled Study: Analysis Of Ema And Fda Approvals 1999–2014

This study aims to explore the prevalence and characteristics of pharmaceutical approvals without randomized controlled trial RCT evidence in the regulatory decisions of the European Medicines Agency

Determining The Frequency Of Pathogenic Germline Variants From Exome Sequencing In Patients With Castrate-resistant Prostate Cancer

Abstract Objectives To determine the frequency of pathogenic inherited mutations in select genes from patients with metastatic castrateresistant prostate cancer mCRPC Design Observational Setting Multis

Effectiveness Of Pharmacist-led Medication Reconciliation Programmes On Clinical Outcomes At Hospital Transitions: A Systematic Review And Meta-analysis

Abstract Objectives Pharmacists play a role in providing medication reconciliation However data on effectiveness on patients clinical outcomes appear inconclusive Thus the aim of this study was to systematically investigate the effect of pharmacistled medication reconciliation programmes on clinical outcomes at hospital transitions

Knowledge integration using product R&D outsourcing in biotechnology

Abstract We build on systems integration literature to explain how and why knowledge integration of nonmodular products is based on a strategic choice between internalizing and outsourcing core RD The underresearched choice of outsourcing core RD on an ongoing basis appears to face risks of higher transactions costs and loss of control We illumina...

Evaluation of retail pharmacists' perception on patient safety

Patient safety has become a focus of clinical care and research in recent years However the potential for medical care to cause harm has been appreciated throughout the history of medicine The safety culture of an organization is the product of individual and group values attitudes perceptions competencies and patterns of behavior that determine t...