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958 积分 2024-09-11 加入
US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development
18天前
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
18天前
已完结
Overview of recently approved 505(b)(2) new drug applications (2010–2012): Role of clinical pharmacology
18天前
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
18天前
已关闭
The liquidity paradox of the 505(b)(2) drug development pathway
18天前
已关闭
Learnings from Approved Antibody‐Drug Conjugates: Clinical Pharmacology Perspectives
1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
1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
1个月前
已完结
Pharmacokinetics, Safety, and Tolerability of GS‐1427, an Oral Prodrug of a Potent and Selective α4β7 Integrin Inhibitor, in Healthy Participants
1个月前
已完结
Combinatorial strategies to target RAS-driven cancers
3个月前
已完结
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