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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. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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The Race for Ozempic Alternatives: Unlocking the Future of Weight Loss Medication

DrugBank

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.

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The Data-Driven Future of Drug Development

DrugBank

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Breaking Barriers: New Developments in Oral Drug Delivery Systems

DrugBank

Oral drug delivery remains the gold standard in pharmaceutical administration. However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges. Drug absorption across the intestinal epithelium further complicates its pharmacokinetics.

Drugs 98
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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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Advanced 3D cell-based technologies

Drug Target Review

The International Consortium for Innovation and Quality in Pharmaceutical Development has published guidelines to qualify as a valid model for specific organ-chip applications. The first successful chip adaptation to a lung model was first described in 2010 by Donald Ingber, a bioengineer at Wyss institute.

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Everest Medicines Announces Amended Agreement with Spero Therapeutics

The Pharma Data

Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. Spero will assign relevant SPR206 patents to Everest Medicines in Greater China, South Korea and certain Southeast Asian countries. SHANGHAI , Jan.