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…
由于最近的监管和临床挫折使人们对基因疗法的前景产生了疑问，基因疗法的现状面临着许多不确定性。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…
儿科 PBPK 模型在药物开发流程中具有广泛应用，正日益广泛用于优化并替代临床研究，However, the approach has yet to become fully…
众多药企苦于原料药（DS）与制剂（DP）杂质的表征及如何将其整合至监管申报资料。This webinar is designed to increase the…
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