About: Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities

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An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
Creator	Feng, Yan Lu, Zheng Nagase, Mario Sheng, Jennifer Zhou, Diansong Al-Huniti, Nidal Yu, Jerry
source	Medline; PMC
abstract	Model‐informed drug development (MIDD) approaches have rapidly advanced in drug development in recent years. Additionally, the Prescription Drug User Fee Act (PDUFA) VI has specific commitments to further enhance MIDD. Tumor growth dynamic (TGD) modeling, as one of the commonly utilized MIDD approaches in oncology, fulfills the purposes to accelerate the drug development, to support new drug and biologics license applications, and to guide the market access. Increasing knowledge of TGD modeling methodologies, encouraging applications in clinical setting for patients’ survival, and complementing assessment of regulatory review for submissions, together fueled promising potentials for imminent enhancement of TGD in oncology. This review is to comprehensively summarize the history of TGD, and present case examples of the recent advance of TGD modeling (mixture model and joint model), as well as the TGD impact on regulatory decisions, thus illustrating challenges and opportunities. Additionally, this review presents the future perspectives for TGD approach.
has issue date	2020-07-22(xsd:dateTime)
bibo:doi	10.1002/psp4.12542
bibo:pmid	32589767
has license	cc-by-nc
sha1sum (hex)	8c102dc19c93355ed6abcf60a263be1029368649
schema:url	https://doi.org/10.1002/psp4.12542
resource representing a document's title	Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
has PubMed Central identifier	PMC7438808
has PubMed identifier	32589767
schema:publication	CPT Pharmacometrics Syst Pharmacol
resource representing a document's body	covid:8c102dc19c93355ed6abcf60a263be1029368649#body_text
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