药物模拟软件开发商Simulations Plus近日宣布，将与全球生物制药公司龙沙及美国食品药品监督管理局（FDA）展开三方合作，共同推进复杂口服药物产品的预测性评估框架开发。
此次合作旨在通过整合先进的计算模型与实验数据，建立更精准的预测体系，以加速复杂口服制剂（包括缓释制剂、难溶性药物制剂等）的研发与审批流程。三方将共享专业知识与资源，致力于提升药物开发效率并降低研发成本。
该合作项目将重点关注基于生理学的生物药剂学模型（PBPK）与体外溶出数据的整合应用，通过建立标准化评估流程，为制药行业提供更可靠的药物性能预测工具。这一举措有望为新型口服药物的临床前研究提供科学依据，并推动监管科学的发展。
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