Model Informed Drug Development Archives

Publication

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal…

Certara2015年5月1日

Publication

Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis

Gastric emptying (GE) is often reported to be slower and more irregular in premature neonates than…

Certara2015年5月1日

Publication

A Model-based Dose-response Meta-analysis of Ocular Hypotensive Agents as a Drug Development Tool to Evaluate New Therapies in Glaucoma

PURPOSE: To characterize dose and response for intraocular pressure (IOP) reduction and incidence of hyperemia…

Certara2015年5月1日

Publication

Month 2 Culture Status and Treatment Duration as Predictors of Recurrence in Pulmonary Tuberculosis: Model Validation and Update

New regimens capable of shortening tuberculosis treatment without increasing the risk of recurrence are urgently…

Certara2015年4月29日

Publication

Effect of Age and Sex on the Pharmacokinetics and Safety of Avibactam in Healthy Volunteers

Avibactam is a novel non-β-lactam β-lactamase inhibitor currently being assessed in combination with ceftazidime, ceftaroline…

Certara2015年4月1日

Publication

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9

RG7652 is a fully humanized monoclonal antibody targeting human PCSK9, a regulator of serum low…

Certara2015年3月31日

Publication

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-controlled Studies

Avibactam is a novel non-β-lactam β-lactamase inhibitor effective against Ambler class A, C and some…

Certara2015年3月27日

Publication

第2期ヒトアフリカトリパノソーマ症の化学療法：非経口ジアミジンDB829と当剤の経口のプロドラッグであるDB868とのベルベットモンキーにおける比較

Human African trypanosomiasis (HAT, sleeping sickness) ranks among the most neglected tropical diseases based on…

Certara2015年2月15日

Publication

Population Pharmacokinetics of Ceftolozane/Tazobactam in Healthy Volunteers, Subjects with Varying Degrees of Renal Function and Patients with Bacterial Infections

Ceftolozane/tazobactam is a novel antipseudomonal cephalosporin and a β-lactamase inhibitor in clinical development for treatment…

Certara2015年2月1日

Publication

Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically-based Pharmacokinetic FcRn Model

Although advantages of physiologically based pharmacokinetic models (PBPK) are now well established, PBPK models that are linked to pharmacodynamic…

Certara2015年1月5日

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モデルに基づく医薬品開発

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis

A Model-based Dose-response Meta-analysis of Ocular Hypotensive Agents as a Drug Development Tool to Evaluate New Therapies in Glaucoma

Month 2 Culture Status and Treatment Duration as Predictors of Recurrence in Pulmonary Tuberculosis: Model Validation and Update

Effect of Age and Sex on the Pharmacokinetics and Safety of Avibactam in Healthy Volunteers

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-controlled Studies

第2期ヒトアフリカトリパノソーマ症の化学療法：非経口ジアミジンDB829と当剤の経口のプロドラッグであるDB868とのベルベットモンキーにおける比較

Population Pharmacokinetics of Ceftolozane/Tazobactam in Healthy Volunteers, Subjects with Varying Degrees of Renal Function and Patients with Bacterial Infections

Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically-based Pharmacokinetic FcRn Model

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