Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage…
This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest in oligonucleotide therapies, which are composed of short strands of DNA or RNA, is growing…
遺伝子治療の現状は多くの不確実性に直面しており、最近の規制や臨床上の失敗によって、その将来性に疑問が投げかけられています。With only two gene therapies FDA-approved for rare diseases to…
In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth…
In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth…
In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth…
小児用PBPKモデルは、医薬品開発プロセスにおいて幅広い応用可能性を有し、臨床試験の最適化や代替手段としてますます活用されています。However, the approach has yet to become fully…
多くの製薬企業が、原薬（DS）および製剤（DP）の不純物の特性評価や、それらを規制当局への申請にどのように組み込むかに苦慮しています。This webinar is designed to increase the…
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