Quantify AD Clinical Outcomes Database
The current version of the database includes clinical safety and efficacy information on all symptomatic drugs as well as newer Abeta drugs currently approved or in development for Alzheimer Disease (AD).
Tag: Model-Based Meta-Analysis (MBMA)
Leveraging Competitor Information to Predict Efficacy of a Novel Drug Formulation
Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support developing a fixed-dose combination of ezetimibe and atorvastatin.
Evaluating the Competitive Landscape to Support a Best-in-class Strategy
Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support dose optimization and product positioning of a psoriasis drug.
A PK/PD Model-based Meta-analysis of Subcutaneously Administered Insulins in Clinical Glucose Clamp Studies
Abundance of Hepatic Transporters in Caucasians: A Meta-analysis
The aim of this study was to derive quantitative abundance values for key hepatic transporters suitable for in vitro-in vivo extrapolation (IVIVE) within a physiologically-based pharmacokinetic modeling framework. A meta-analysis was performed whereby abundance measurements, sample preparation method and donor demography were collated from literature. In order to define values for a healthy Caucasian population, … Continued
Using Model-based Meta-analysis to Improve Decision-making in Drug Development
Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. 承認された医薬品および開発中の医薬品の両方に関する公開情報は非常に多く存在します。こうした状況下で、スポンサー企業はどのように臨床試験データに基づいて、開発医薬品の成功への道筋をつける知見を獲得することができるでしょうか？
モデルに基づくメタ解析（MBMA）：革新的な手法の誕生
MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions. The insights gained via MBMA support designing less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio.
Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis
The objective of this study was to assess the relationship between short-term and long-term treatment effects measured by the American College of Rheumatology (ACR) 50 responses and to assess the feasibility of predicting 6-month efficacy from short-term data. A rheumatoid arthritis (RA) database was constructed from 68 reported trials. We focused on the relationship between … Continued
Quantify Depression Clinical Outcomes Database
The Quantify Major Depression Disorder (MDD) Clinical Outcomes Database documents clinical efficacy and safety information from randomized and controlled regulatory trials investigating monotherapy and adjunctive therapy pharmaceutical drugs for major depression disorder and treatment-resistant depression.
Partnering for Pharmacometric Impact
• Quantifying clinical trial efficacy, tolerability, and safety information to enable informed drug development decisions
• Incorporating quantitative pharmacology models for the effects of treatment, time, and patient characteristics on therapeutic outcome
• Competitive positioning, quantitative definition of Best-in-Class, assessment of drug class characteristics, and optimizing clinical trial designs
