Authors
Latest:
A Practical Approach of Implementing GMP for ExcipientsUsing a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
Latest:
Research Spend On Cancer Doubles Within A DecadePartners of the UK's National Cancer Research institute (NCRI) have nearly doubled their spend on cancer research in the last ten years.
Latest:
Key Considerations When Choosing Your Cleanroom DoorOne of the biggest challenges in designing cleanroom doors for the pharmaceutical industry is in creating a sturdy door with a high hygienic performance that is light and easy to clean.
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Latest:
De-activating the Ticking Bomb of Brain Diseases with NanomedicinesNanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
Latest:
Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
Latest:
Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Latest:
Assessing and Improving the Palatability of PharmaceuticalsTaste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.
Latest:
Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
Latest:
Weighing Clinical Trial Outsourcing OptionsEvolving clinical trial research services give biopharmaceutical companies options for full and functional services.
Latest:
Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
Latest:
Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
Latest:
Demonstrating BiosimilarityExtensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.
Latest:
Europe's Need for Early Development Pharmaceutical Manufacturing ExpertiseDespite the growth of specialist companies with capabilities across various therapeutic areas in Europe, there is still a need for early development expertise with end-to-end pharmaceutical manufacturing capabilities.
Latest:
De-activating the Ticking Bomb of Brain Diseases with NanomedicinesNanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
Latest:
Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
Latest:
Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Latest:
Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Latest:
Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
Latest:
Best Practices for Stability Testing of BiologicsExperts discuss crucial aspects of measuring the stability of biologics, which exhibit greater variability in stability testing than do small-molecule drugs.
Latest:
Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Latest:
Comparing Manufacturing Process OptionsA techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.
Latest:
Point-of-Use Leak Testing of Single-Use Bag AssembliesThe authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
Latest:
Using Flow Sensors to Monitor Process System HealthUsing flow sensors, operators can monitor compressed-air use to help identify problems early and provides data for improving energy efficiency.
Latest:
Bolstering Graduate Education and Research ProgramsAAPS supports graduate-level programs impacted by cutbacks in funding and resources.
Latest:
Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
Latest:
An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Latest:
Using Ultrasonic Cleaning for Equipment and ToolingUltrasonic cleaning of solid-dosage tooling and other equipment, such as filling-machine valves and nozzles, is more effective than hand cleaning.
