Lv51
1128 积分 2024-09-11 加入
Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions
4小时前
待确认
Efficacy and Safety of Doxepin 1 mg, 3 mg, and 6 mg in Adults with Primary Insomnia
1个月前
已完结
US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development
2个月前
已完结
Review on 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020 Emphasizing Intellectual Property and Regulatory Considerations for Reformulations and New Combinations
2个月前
已完结
Overview of recently approved 505(b)(2) new drug applications (2010–2012): Role of clinical pharmacology
2个月前
已完结
A multi-dimensional comparative study of 505(b)(2) NDAs approved by FDA and Class 2 NDAs approved by NMPA from 2017 to 2023: Uncovering trends, characteristics, and regulation of modified new drugs
2个月前
已关闭
The liquidity paradox of the 505(b)(2) drug development pathway
2个月前
已关闭
Learnings from Approved Antibody‐Drug Conjugates: Clinical Pharmacology Perspectives
3个月前
已完结
The Pharmacokinetics and Relative Bioavailability of a Mini‐Tablet of Mercaptopurine, a Novel Formulation for Use in Children with Acute Lymphoblastic Leukemia
3个月前
已完结
Model‐Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC : A QSP Model for Alpelisib and Tipifarnib Combination
3个月前
已完结
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