Central Nervous System (CNS) Archives

Case Study

重要な医薬品：Biohaven社の Nurtec™ 医薬品開発のジャーニー

In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…

webdev2024年8月15日

Case Study

Simcyp Simulator を使用した小児における Guanfacine の DDI 責任の判定

Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…

Jim Gallagher2021年8月26日

Case Study

Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates

Radiprodil is a selective allosteric modulator of the NR2B N-methyl-D-aspartate receptor GluN2B-NMDA that was being…

Jim Gallagher2021年8月26日

Case Study

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to…

Jim Gallagher2021年8月26日

Case Study

Simcypの年齢定義機能により、新生児へのエベロリムス投与が容易に

Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…

Jim Gallagher2021年8月26日

Case Study

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…

Jim Gallagher2021年8月12日

On-Demand Webinar

Advanced Analytics Using RWD Mitigates Risks in AD Drug Development & Reimbursement

This webinar explained how advanced analytics using real-world data can mitigate challenges in Alzheimer’s disease…

webdev2019年5月13日

Poster

Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics

webdev2019年4月22日

Poster

Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin

webdev2018年11月4日

Publication

Pharmacokinetic Properties of a Sufentanil Sublingual Tablet Intended to Treat Acute Pain

webdev2018年5月1日

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中枢神経系(CNS)

重要な医薬品：Biohaven社の Nurtec™ 医薬品開発のジャーニー

Simcyp Simulator を使用した小児における Guanfacine の DDI 責任の判定

Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Simcypの年齢定義機能により、新生児へのエベロリムス投与が容易に

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Advanced Analytics Using RWD Mitigates Risks in AD Drug Development & Reimbursement

Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics

Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin

Pharmacokinetic Properties of a Sufentanil Sublingual Tablet Intended to Treat Acute Pain

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