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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.
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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.
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.
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Evolving to Meet Industry ChangesIn the development of biopharmaceuticals and pharmaceuticals, the line is blurring.
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Identifying Problems in Induction SealingProblems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
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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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Leveraging Change for Continuous Process ImprovementManaging change and overcoming employee resistance and fear requires a proactive approach.
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Sanofi Targets Tuberculosis TreatmentsSanofi has entered into a research collaboration with the Weill Cornell Medical College in New York to develop new anti-infectives that aim to both shorten the course of treatment for tuberculosis and provide effective therapies against drug-susceptible and drug-resistant strains of the disease.
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Keys to Executing a Successful Technology TransferThe authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.
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Innovative Contracting Solutions in a Changing Healthcare LandscapePharmaceutical and biopharmaceutical manufacturers must start thinking about new ways to navigate the evolving healthcare marketplace while continuing to deliver life-changing therapies to patients and responding to the demands of an increasingly informed and sophisticated customer base.
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Innovative Contracting Solutions in a Changing Healthcare LandscapePharmaceutical and biopharmaceutical manufacturers must start thinking about new ways to navigate the evolving healthcare marketplace while continuing to deliver life-changing therapies to patients and responding to the demands of an increasingly informed and sophisticated customer base.
