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The benefits of risk-based analyses during system validationWhen validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.
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Evaluating the Impact of the Falsified Medicines Directive in SwitzerlandAs the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.
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Packaging: The Experts' ViewLeading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.
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Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch ReleaseThis article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.
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Establishing a Minimum Incubation Time for Biological IndicatorsThe industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
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Dynamic avalanching accurately assesses flowability and qualityCefaclor is a β-lactam cephalosporin antibiotic that has a wide particle size distribution. Because of the nonporous nature of the material, the specific surface area value accounts for a significant amount of fine particles possibly present in the samples under analysis.
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The combination drugs debate: Incompatibility problems can be overcomeCombining drugs with synergistic mechanisms of action yields some indisputable benefits; improved efficacy, reduced dosing, enhanced patient compliance, to name just a few.
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Implications and Opportunities of Applying QbD Principles to Analytical MeasurementThe authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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Stabilization of Interferon alpha-2b in a Topical CreamThe authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.
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Simplifying data managementPaper is no longer a sufficient format for information storage and interchange in the pharmaceutical industry; documents are inflexible and costly for production and storage.
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The Relevance of Continuous Solid Oral Dosage Processing and NIR Spectroscopy In Meeting the Needs of QbD and PATThe author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.
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Evaluating Functional Equivalency as a Lyophilization Cycle Transfer ToolThe authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
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Stabilization of Interferon alpha-2b in a Topical CreamThe authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.
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Innovations in dissolution testingHaving been directly involved in the evolution of dissolution testing since its introduction in the early 1970s and variously representing Hanson, Van Kel, Sotax and Erweka prior to developing our own range of dissolution testers in 2002, I would have to say that advances in dissolution testing technology have been one of the biggest breakthroughs in solid dosage form testing over the last decade.
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Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
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Is another ODT excipient necessary?Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.
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Belgium: Will its enviable geographic position continue to ensure success in pharma?Belgium is one of the largest centres for pharmaceutical distribution and has the second highest number of pharma exports per capita worldwide.
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Nanotechnology: the next silver bullet?A number of commentators during the past few years have speculated that nanotechnology is the wave of the future in biotech and pharma.
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Resealed Erythrocytes: A ReviewErythrocytes, the most abundant cells in the human body, have potential carrier capabilities for the delivery of drugs.
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Is There Such a Thing as a Best-in-Class Lab? Benchmarking of QC OperationsThis article investigates what defines a best-in-class QC lab based on experience of implementing operational improvement projects in world-class labs. It includes an assessment of a benchmarking process, a case study of improvements made as a result at one company and findings on what constitutes best-in-class for QC labs.
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What to consider when expanding businesses into North AmericaIncrease your chances of success in the biggest market in the world.
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Selection of Suitable Drug and Excipient Candidates to Prepare Glass Solutions by Melt Extrusion for Immediate Release Oral FormulationsUsing melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.
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High-Resolution Ultrasonic Spectroscopy: Analysis of MicroemulsionsThis article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.
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Challenges in coatingOne of the biggest changes in recent years that has impacted tablet coating technologies is the introduction of 21 CFR Part 11, which deals with electronic records and electronic signatures.
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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFsAppendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
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Opportunities and Challenges in Pharmaceutical NanotechnologyWhile regulators begin to address nano-based drugs, industry should get its risk data ready.
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Evaluating Functional Equivalency as a Lyophilization Cycle Transfer ToolThe authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
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What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.
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Integrating PAT into biopharmaceutical research: a case studyThis case study describes the implementation of process analytical technology on the cultivation process step of a whole-cell vaccine against whooping cough disease.
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Dynamic avalanching accurately assesses flowability and qualityCefaclor is a β-lactam cephalosporin antibiotic that has a wide particle size distribution. Because of the nonporous nature of the material, the specific surface area value accounts for a significant amount of fine particles possibly present in the samples under analysis.
