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Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Latest:
Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Latest:
Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Latest:
Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Latest:
Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Latest:
Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Latest:
Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making is compared with a QbD approach.
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Biologics Facilities Expand and Establish New Locations in 2021The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space.
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Detecting Residual Moisture in Lyophilized ProductThere are several common methods for detecting residual moisture in drug products that have been lyophilized; here are some key points to consider when selecting a method or developing one.
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Mitigating the Risk from Excipient VariabilityThis article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
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Additives and Processing Aids in Pharmaceutical ExcipientsThis article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.
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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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Additives and Processing Aids in Pharmaceutical ExcipientsThis article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.
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Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium CarboxymethylcelluloseIn this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
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Accelerating Biosimilar AnalysisMass spectrometry should be utilized effectively to optimize biosimilar analysis, which can reduce development time and cost.
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Integrating Powder Characterization into Raw Material Selection and Process OptimizationAs tests at GSK have shown, integrating powder testing into overall operations can optimize process understanding, and with it, raw material selection, equipment design, and process development.
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Inhalation Drug Delivery: The Impact of Particle Size ReductionResearch compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
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Inhalation Drug Delivery: The Impact of Particle Size ReductionResearch compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
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Inhalation Drug Delivery: The Impact of Particle Size ReductionResearch compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
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Transform Your Lab Workflows and Resource Utilization***December 8, 2020 at 10am EST| 3pm GMT| 4pm CET*** Join this live webcast to learn more about a unique and powerful integration between lab scheduling and lab procedure execution, leading to an 80% reduction in time spent planning and organizing work as well as 10x reduction in compliance risk through standardized processes..*** On demand available after final airing until Dec. 8, 2021.***
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The PDA Pharmaceutical Microbiology Conference: The Hottest Ticket in the IndustryGet a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
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Specification Equivalence—A Practical ApproachIn this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
Latest:
Specification Equivalence—A Practical ApproachIn this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
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Supply-Chain Security from a European PerspectiveGlobal harmonisation would help improve supply-chain security and reduce the flow of falsified and sub-standard medicine into Europe.
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In-line Laser Marking of Silicone TubingPharmaceutical companies require marked components for lot traceability but problems occur within secondary processing and with traditional printing methods.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
Latest:
Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
Latest:
Automation on Display at Healthcare Packaging ExpoAutomated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.
