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This article outlines the preclinical studies to assess and manage developability risks of NMEs for oral drug products
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The Role of Roller Compaction in Dose Design
Roller compaction is a popular dry granulation process with some significant advantages over wet granulation processes.
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How to create a development strategy that bridges gaps earlier in the process to make the transition smoother.
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Using Lipid Based Delivery For Early Phase Development
Lipid-based drug delivery systems provide a reliable solution for poorly soluble molecules
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Particle Size Reduction
Characterization of the micronized drug is important to understand its bulk properties and design downstream processes and manufacturing approaches.
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Clarifying the myths surrounding LBDSS which may make drug developers consider it in parallel to other formulation approaches
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Phase Appropriate Stability Studies
Stability is a critical quality attribute of pharmaceutical products
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Current critical issues facing the oral solid dose manufacturing industry
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Developers are looking for ways to predict and overcome potential issues of new molecular entities
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Formulation Design in Oral GLP Toxicology Studies
Read this article and learn about focus areas in the early drug development process that are critical for a successful toxicology study.
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