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Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
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Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
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Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
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Dry Particle Coating—A Unique Solution for Pharmaceutical FormulationAston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
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Dry Particle Coating—A Unique Solution for Pharmaceutical FormulationAston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
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High Throughput Screening of ExcipientsThe author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.
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Removing the Bitter Taste from Drug DevelopmentIntegration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.
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Transition From Clinical to Commercial Supply Chain-Regulatory Starting MaterialsThe authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.
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Transition From Clinical to Commercial Supply Chain-Regulatory Starting MaterialsThe authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.
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Why Good Records Management Is KeyThe past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be signing more preferred partner deals, such as Pfizer teaming with Parexel and ICON, and Takeda?s deals with Covance and Quintiles, which is driving mid-size CROs growth through major acquisitions.
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Microbiology & toxicology contract testing for the pharmaceutical and medical device industriesWickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries with over 50 years of experience in contract testing, research and consultancy.
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Partnership Models Structure R&D ChangePharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development.
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Cleaning Validation for Pharmaceutical ManufacturingThis paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.
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Excipient Science in Protecting Moisture Sensitive DrugsDon’t just rely on packaging to protect drug products from moisture. In this webcast, discover how to develop more stable formulations by selecting the right excipients for use with moisture-sensitive drugs, and in doing so, reduce the risk of degradants and impurities. Live: Asia Pacific: Wednesday, Jun. 3, 2020 at 12pm IST | 2:30pm CST | 3:30pm JST US and Europe: Wednesday, Jun. 3, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Jun. 3, 2021 Register free
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Advances in the Pharmaceutical Industry Have Shaped Particle Sizing TechnologyA diverse range of particle sizing solutions is available, from techniques for the characterization of complex formulations through to online PAT tools for real-time measurement.
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Centrifuges Used in Pharmaceutical Manufacturing: A PrimerFour types of centrifuges used in pharmaceutical manufacturing have different features.
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Emerging Opportunities with BiosimilarsTo realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.
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Making the Move to Electronic Batch RecordsImplementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
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Making the Move to Electronic Batch RecordsImplementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
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Pulling Together to Advance Patient-Focused Drug ProductsMore work needed to advance drug design and development effectively.
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Future Therapies Using Implanted Engineered Cells as Protein FactoriesResearchers at MIT have discovered a new set of compounds that do not elicit a foreign body response when implanted. These biomaterials permit the development of a new category of treatment with the ability to deliver therapeutics either at a constant rate or under programmable conditions by using implantable cells as protein factories.
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Complying with Good Engineering Practices for Mechanical Integrity of Process EquipmentDesigning a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.
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How to Perform Ignition and Drying Methods Such as USP and USP More Safely Without Sacrificing PerformanceJoin Ian Olmsted, PhD, to learn how you can perform ignition and drying methods more safely, without sacrificing data quality or workflow. He will explore the hazards associated with sulfated ashing and moisture content analysis in the pharmaceutical industry. Live: Thursday, Mar. 26, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET On demand available after airing until Mar. 26, 2021 Register free
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Managing Pharmaceutical Recalls with AutomationHow warehouse execution systems can help in case of a drug recall.
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Evaluating the Impact of Sterilization on Gel FormulationsResearch suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
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Evaluating the Impact of Sterilization on Gel FormulationsResearch suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
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Evaluating the Impact of Sterilization on Gel FormulationsResearch suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
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Evaluating the Impact of Sterilization on Gel FormulationsResearch suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
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Evaluating the Impact of Sterilization on Gel FormulationsResearch suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
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Evaluating the Impact of Sterilization on Gel FormulationsResearch suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.
