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Turkey Increases R&D IncentivesLast year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.
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Turkey Increases R&D IncentivesLast year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.
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Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze DryingA new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
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Bioprocessing Facilities and FDA Inspection ProblemsFDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in terms of recovery, purification, and formulation.
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Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Are Project Management Services Right for You?Project management services can help companies experience reduced time to market, less costly manufacturing processes, and more efficient information flow.
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New Gene Patent RulesThe US Supreme Court's Myriad decision satisfied both patient groups and patent holders
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E-Validation: A Method for Electronic Validation Protocol Generation, Approval, and ExecutionAn all-electronic validation can provide storage costs savings and ensured document legibility.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Fixed-Dose CombinationsFixed-dose combinations (FDCs) reduce the number of pills that must be taken, but they have also been a topic of concern, mainly because of the perceived potential for increased adverse events. PTE speaks with researchers to explore the benefits and concerns of FDCs.
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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.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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The Development of a Floating Drug-Delivery System for MetronidazoleThe authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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Biosimilar Development: 10 Years OnWith a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.
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Developing and Sustaining a Quality CultureEmployee training-at all levels-is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.
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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.
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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.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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Assessing and Improving the Palatability of PharmaceuticalsTaste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.
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One Step Back, Two Steps Forward to Improved Quality ProcessesLife-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.
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Deficiencies Found in API InspectionsPIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
