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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Manufacturing and Quality Control : The PMDA evaluates the manufacturing process and quality control measures of the generic drug to ensure compliance with Japanese regulatory standards. Clinical Pharmacology & Therapeutics , 111(3), 531538. Journal of Clinical Pharmacology , 51(3), 531538. Freyr Solutions.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics.

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Conversations in Drug Development Trends

From instrument integration to data processing, automation ensures regulatory compliance and enhanced scalability, which is necessary for the increasing demand for novel treatments across therapeutic areas. At our bioanalytical facility, we stay atop by embracing current and emerging trends.

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Angel Reyes Joins Altasciences as General Manager of CDMO Services

Alta Sciences

He brings to Altasciences over a decade of experience in management and supervisory roles for manufacturing operations and supply chains, having demonstrated an impeccable standard in ensuring adherence to compliance and cGMP policies. Altasciences helps sponsors get better drugs to the people who need them, faster.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection. Here are a few of our lessons learned: 1.

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Top 10 Life Science Resources for Summer 2024

Alta Sciences

Watch the webinar. jpg Synopsis Discover 10 more essential life science resources, including expert insights, tips, case studies, webinars, podcasts, posters, scientific publications, videos, and more, that you may have missed from us!

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