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Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
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Public Health Organizations Pen Letter to House and Senate CommitteesNine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
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New Lab Instruments Tackle Workflow ChallengesA sampling of new laboratory equipment showcases streamlined operations.
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Addressing Segregation of a Low-Dosage Direct BlendThe authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
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Futureproofing the Pharmaceutical Industry through TechnologyBy focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.
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Determination of Sodium Chloride in Yeast Extract by Ion ChromatographyDetermination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.
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Selecting the Appropriate Technology for Oral Bioavailability EnhancementModel-based formulation and technology selection methodologies facilitate rapid product development.
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Practical Approaches to Tech Transfer and Scale-up of Lyophilization ProcessesTroubleshooting and collaboration are essential in implementing commercial lyophilization processes.
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Practical Approaches to Tech Transfer and Scale-up of Lyophilization ProcessesTroubleshooting and collaboration are essential in implementing commercial lyophilization processes.
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A QbD Method Development Approach for a Generic pMDIApplication for Sirdupla Uniformity of Delivered Dose Methodology
