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Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies

Alta Sciences

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. Do you need a pharmacokinetic study?

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market.

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Toxicology transformed: Why accuracy now leads the way

Drug Target Review

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Special attention is required when dealing with antibody-based therapeutics due to their high susceptibility to biotransformation.

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The future of CNS drug development: signs of real progress

Drug Target Review

A board-certified toxicologist, she specialises in designing and managing nonclinical programmes across various modalities, including toxicology, pharmacokinetics, ADME and safety pharmacology. Prior to WuXi AppTec, Dr Li held scientific leadership roles in CROs and pharmaceutical companies in Canada and Japan.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring.

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When to Slow Down or Hit the Brakes on a Development Program

The Premier Consulting Blog

Pharmaceutical companies may, at times, find themselves at an impasse during development, facing weighty decisions about whether to slow down or hit the brakes on a development program. These decisions are complex, multi-dimensional, and can have significant impact on the future of the company.

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Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

In the world of generic drugs, we have something even better: Physiologically Based Pharmacokinetic Modeling (PBPK). The Plot: Generic vs. Brand-Name Two major pharmaceutical companies sued over 10 generic drug manufacturers for infringing on a patent for their schizophrenia medication[4]. The bone of contention?