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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan.

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Altasciences and VoxCell Partner to Boost Preclinical Drug Development

The Pharma Data

This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinical development with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.

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Altasciences and VoxCell BioInnovation Announce Strategic Collaboration to Advance Preclinical Drug Development

Alta Sciences

This partnership combines Altasciences’ comprehensive early-phase drug development capabilities with VoxCell’s cutting-edge 3D tissue technology to offer a more predictive and human-relevant preclinical testing environment.

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The rising impact of biomarkers in early clinical development

Drug Target Review

Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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

Conversations in Drug Development Trends

End-to-end workflow automation, from sample receipt, processing, analysis, and reporting, will likely become an industry standard, making it an essential tool for drug development. Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drug development.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. For gene therapy products, the use of quantitative and sensitive assays such as qPCR are recommended.