Research Insights
Research Insights section focuses on the cutting-edge and breakthrough research that is happening all over the world. Laboratories across the globe are working hard to develop drugs and therapies for various diseases and research insights directly from them add tremendous value.
A Simple And Sensitive Method To Analyze Genotoxic Impurity Hydrazine In Pharmaceutical Materials
Abstract Hydrazine NH is a known genotoxic impurity that typically needs to be controlled down to low ppm level in pharmaceutical development Hydrazine however is a challenging molecule to analyze using conventional analytical techniques due to its physical and chemical properties eg lack of chromophore absence of any carbon atom low molecular wei...
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
Abstract The use of near infra red spectroscopy to predict the concentration of two pharmaceutical cocrystals ibuprofen nicotinamide IBUNIC and carbamazepine nicotinamide CBZNIC has been evaluated A Partial Least Squares PLS regression model was developed for both cocrystal pairs using sets of standard samples to create calib
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
Abstract Background 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 to engage patients in research and regulatory activities the pharmaceutical industry has yet to max
Regulatory Approval Of Pharmaceuticals Without A Randomised Controlled Study: Analysis Of Ema And Fda Approvals 1999–2014
Abstract Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials RCTs however in some cases regulatory applications lack RCT evidence Objective To investigate the number and type of these approvals over the pa
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...
