Authors
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EU Market ChallengesAlthough the European market is approximately 50% smaller than the US in terms of landmass, the population of Europe is approximately 50% larger and this presents a huge market opportunity.
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Offering a Pharma View of Social MediaWhy social media presents unique challenges and opportunities for pharmaceutical companies.
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Technology and QbD Drive Pharma DevelopmentQuality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.
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Data Governance, Data Integrity, and Data Quality: What’s the Connection?Data governance, data integrity, and data quality are all widely used terms, but what do they actually mean and how are they connected?
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The Relationship Between Packaging And The PatientIn light of the challenges facing the pharma industry, such as changing patient demands and changing demographics, the relationship between the packaging, the consumer and the product is being completely reconsidered.
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Guest Viewpoint: A Case for an FDA Dean's ListQuality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.
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The Future of Downstream ProcessingThe author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies.
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Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified CommunicationsIn Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success.
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Impurity Profiling Using Convergence Chromatography and Mass SpectrometryThe authors describe the use of convergence chromatography combined with mass spectrometry for impurity profiling.
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Bridging the Gap from Molecule to DrugFormulation expertise can smooth the transition of a prospective therapy from medicinal chemistry to drug dosage form.
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QbD: Improving Pharmaceutical Development and Manufacturing Workflows to Deliver Better Patient OutcomesImplementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.
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Checklist for Computer Software ValidationNon-compliance issues show that users find dealing with computer systems challenging.
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Achieving Lean Processing With Single-Use SystemsSingle-use filtration and fill–finish technologies can be used as part of a lean manufacturing strategy to boost production, and reduce manufacturing waste and costs.
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Can Bigger be Better?The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.
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Specifying a tumble blender for pharmaceutical manufacturingTumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning. This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application.
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Creating a Successful Partnership with a Contract ManufacturerEffective partnerships between research and manufacturing operations can streamline the process of bringing a product to market.
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Selecting Lactose for a Capsule-Based Dry Powder InhalerDry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.
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Capsule-in-Capsule TechnologyThe author outlines how to choose carriers and capsule shells according to dosage requirements and intended use. This article is part of a special Drug Delivery issue.
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Manufacture and Dissolution Studies of Lipid Spheres: Part IIPrevious articles have presented a general review of the different types of spheres that can be obtained using a rotary fluidized bed process.1,2 Part I of this study focussed on lipid spheres prepared using hydrogenated castor oil for formulations with low active drug content. The feasibility of the process and the main characteristics of spheres obtained were also studied. In Part II, formulations with higher concentrations of active drug are examined.
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How Excipient Supplier Certification Helps Pharmaceutical Supply Chain in EuropeThe EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.
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Polymers for Solubility EnhancementNew chemical entities with poor aqueous solubility require the use of technologies to enable sufficient oral bioavailability of these NCEs following administration.
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Erythritol: A New Multipurpose ExcipientErythritol is a bulk sweetener polyol that is suitable for a variety of reduced-calorie and sugar-free foods. It has been part of the human diet for thousands of years because of its presence in foods such as fruit, mushrooms and fermentation-derived products including wine, soy sauce and cheese. This article investigates the properties of erythritol and describes how it can be used as a pharmaceutical excipient.
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Overcoming Common Lyophilization Scale-Up IssuesThe same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.
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Large Industry Cross-Section Contributes to PDA Quality Metrics RecommendationsPDA works with FDA to create pharmaceutical quality metrics.
