Model-Informed Therapeutic Dose Optimization Strategies for
网页These include body weight cap dosing; treatment duration capping; dose schedule (e.g., dosing frequency and dose fractionation); response-guided dosing recommendations; and randomized dose-finding. We then discuss how the lessons learned from these studies can inform ADC development going forward.
Model‐Informed Therapeutic Dose Optimization Strategies for …
网页2021年4月26日 — These include body weight cap dosing; treatment duration capping; dose schedule (e.g., dosing frequency and dose fractionation); response-guided dosing recommendations; and randomized dose-finding. We then discuss how the lessons learned from these studies can inform ADC development going forward.
Applications of Model Informed Drug Development (MIDD) in Drug …
网页2022年7月5日 — Model-informed drug development (MIDD) is the application of a wide range of mathematical, statistical, and biological models to facilitate drug development, decision making and regulatory review [1,2,3]. If applied successfully, MIDD approaches have the potential to significantly streamline drug development and …
网页A new, overarching guideline on General Principles for Model-Informed Drug Development (MIDD) to broadly cover general principles and good practices for use of MIDD in regulatory submissions.
Model-Informed Drug Development Paired Meeting Program
网页2024年6月5日 — The FDA is conducting a Model-Informed Drug Development (MIDD) Paired Meeting Program that will build on the success of the MIDD Paired Meeting Pilot by continuing to advance and integrate...
Dose Optimization Informed by PBPK Modeling: State‐of‐the Art …
网页2024年4月30日 — Model-informed drug development (MIDD) is a powerful quantitative approach that plays an integral role in drug development and regulatory review. While applied throughout the life cycle of the development of new drugs, a key application of MIDD is to inform clinical trial design including dose selection and optimization.
Physiologically Based Pharmacokinetic Model-Informed Drug Development ...
网页For the first time, we developed a physiologically based pharmacokinetic (PBPK) model-based approach to assess CYP3A-mediated drug-drug interaction (DDI) risk for polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC). The model was developed and verified using data from the …
网页General recommendations on high- level strategic planning, data qual-ity and relevance, planning and imple-mentation of analysis, interpretation of results, reporting, and documentation, with the objective to improve commu-nication of …
Model-Informed Drug Development: Current US Regulatory
网页Model-informed drug development (MIDD) refers to the application of a wide range of quantitative models in drug development to facilitate the decision-making process. MIDD was formally recognized in Prescription Drug User Fee Act (PDUFA) VI.
Discovery and development of ADCs: obstacles and opportunities
网页2023年1月1日 — During drug discovery, PK/PD modeling and simulation strategies can be used to triage lead ADC candidates, identify critical parameters to optimize ADC design, evaluate different potential targets, investigate attributes of ADC efficacy (i.e., the bystander effect), or examine different hypotheses or strategies (i.e., strategies to enhance ...
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