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Science, Empiricism, and Off-label UseWas FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?
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Needle-Free InjectionNeedle-free injection technologies have been developed for injecting liquid formulations, as well as injecting drugs and vaccines in a solid dosage form.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Microneedle Array Patch InnovationsKindeva’s microneedle array patch platforms for solid and liquid APIs have the potential to deliver far-reaching clinical, environmental, and usability benefits.
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Understanding Concomitant Components in Pharmaceutical ExcipientsViewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
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Restructuring Method Transfer Through Global SitesMethod-transfer kits help simplify analytical method transfer for global site certifications.
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Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic MeasurementsThe authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.
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New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483sThe authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
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Application Note: Maintaining Batch-to-Batch ConsistencyProduct variability from biopharmaceutical manufacturing to storage can significantly impact the safety and efficacy of batch-to-batch products during clinical use.
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Pharmaceutical Compounding Calculations, Part Two–Bulk DrugsBulk drug calculations for different types of active moieties and drugs require different calculations and labeling.
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BENEO galenIQ™BENEO produces galenIQ™, a water-soluble filler and binder. galenIQ™ has a sweetness and taste profile similar to sucrose, therefore it’s used to improve palatability of bitter-tasting active pharmaceutical ingredients and plant extracts.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug ProductsThis article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.
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Harnessing Predictive Simulation to Improve MixingPredictive computational methods are finding wider use in pharmaceutical solid dosage development, particularly in mixing and blending, to improve tech transfer and equipment selection, and speed the acquisition of process understanding.
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Best Practices for Designing and Building a Pharmaceutical Manufacturing FacilityFor drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.
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Drug Substance Starting Material SelectionThe authors review the current regulatory framework for the selection of drug substance starting materials.
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Nanotechnology: A lifeline for drying pharma pipelines?Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
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A bioanalytical discovery strategy for fast and flexible decision makingWebinar Date/Time: Wed, Oct 11, 2023 11:00 AM EDT
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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Pharmacovigilance Under Scrutiny: Why Companies are Falling ShortDespite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.
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Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow-Fill-Seal (BFS) Plastic VialSee how stability of a formulation in Woodstock Sterile Solutions’ primary container design compares to glass vials.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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In-line UV Spectrometry Monitoring in Cleaning ValidationThe authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.
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Developing a Contamination Control StrategyThis whitepaper provides an overview of developing a comprehensive contamination control strategy (CCS), taking into consideration the various aspects of pharmaceutical manu
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Developing and Executing a Campaign to Boost Web Traffic by 85%Read about how we helped The Clinician increase users to their website by 85%, new users by 92%, and sessions by 94%
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The Necessary Role of Integrity Testing in Laboratory Sterility FiltrationAssessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.
