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Carbohydrates For InjectionElham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.
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Establishing Limits for Dermal Absorption of Elemental ImpuritiesCurrent guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
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Data Integrity: Getting Back to BasicsEnsuring data integrity involves effort on an individual and global basis.
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Guidance on Quality Culture StandardsMatt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
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Utilizing Run Rules for Effective Monitoring in ManufacturingTo enable efficient monitoring systems, life-science companies need to effectively apply run rules.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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The Many Varieties Of 'Emerging'While most companies recognise the significance of emerging markets, they struggle to jump the first hurdle in addressing these opportunities: defining the right product.
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Lessons Learned from FDA Inspections of Foreign API FacilitiesA study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)
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Lessons Learned from FDA Inspections of Foreign API FacilitiesA study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)
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Technical Note: The Effect of Alcoholic Beverages on Sustained ReleaseThe authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.
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Advancements in Encapsulation TechnologyTechnological advancements can address the formulation and dissolution challenges of HPMC polymers.
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Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release FormulationsThis article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
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Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release FormulationsThis article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
Latest:
Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release FormulationsThis article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
Latest:
Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release FormulationsThis article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
Latest:
Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release FormulationsThis article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
Latest:
Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release FormulationsThis article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
