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1-15 of 43 results
Molnar-Institute: Benefits and Capabilities of DryLab®
| By Molnár-Institute
Anybody working in the realm of HPLC who wishes to economize the resources spent developing and running methods can benefit from the advantages offered by DryLab®.
Contract Research & Services > Contract Services > White Papers
Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D
| By Butterworth Laboratories Ltd
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.
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DryLab®4 - An Overview
| By Molnár-Institute
Exploring DryLab basics, method development strategy and DryLab benefits.
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DryLab®4 - Next Generation in HPLC Modeling
| By Molnár-Institute
DryLab® is the leading software solution for HPLC method development, optimization, troubleshooting, robustness testing and training. With less than 12 experimental runs, DryLab® is the only tool capable of delivering over one million precise chromatograms predictions and display the results in its user friendly interface. Its enhanced features will transform your chaotic method development into a comfortable and streamlined workflow, as well as increasing your productivity.
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Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling
| By Molnár-Institute
The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.
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Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
| By Butterworth Laboratories Ltd
In recent times there has been a large increase in the type and number of products packaged using Modified Atmosphere Packaging (MAP) procedures. The majority of these processes concern the removal of oxygen from packaging systems in order to reduce oxidative degradation of the product and increase shelf life. Whilst most of the historical development of MAP took place within the food industry, over the last 20 years there has been a large growth in its application within the pharmaceutical sector.
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Transform Clinical Development Through Advances in Risk-Based Monitoring
| By Quintiles
This paper shares the challenges of clinical development along with an approach to trial execution gleaned from years of executing trials with risk-based monitoring (RBM) policies and processes.
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Integration of Molecular Biomarkers into Clinical Development
| By Quintiles
In the first of this two-part series, strategic drug developers Eric Groves, Jason Hill and Christopher Ung explain why biopharma cannot afford to ignore the growing surge of interest in biomarkers in oncology and discuss their critical role in the modern-day clinical development process.
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Personalizing Oncology with Genomics
| By Quintiles
Next-generation sequencing will transform oncology clinical trials and treatments for cancer.
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Biomarkers: Recent Advances in Their Application to the Treatment of Hematologic Malignancies
| By Quintiles
Biomarkers hold promise in the diagnosis, prognosis and therapeutic stratification of hematopoietic malignancies. These heterogeneous diseases - including multiple myeloma, lymphomas and leukemias - are frequently characterized cytogenetically with diagnoses supported by genetic, immunohistochemical and flow cytometric analyses.
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Integrating Biomarkers in Alzheimer’s Disease Trials
| By Quintiles
Review of compliance with biomarker assessments in Alzheimer’s disease clinical trials.
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Biomarkers: Key to Better Rheumatoid Arthritis Drug Development and Treatment
| By Quintiles
Rheumatoid arthritis (RA) affects approximately 1% of the world’s population with an ever-increasing burden on health, quality of life and the economy.
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Amino Acid Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.
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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.
| By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.
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Elemental Impurity Analysis in Pharmaceuticals
| By Butterworth Laboratories Ltd
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.
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1-15 of 43 results