Therapeutic Specialties Archives

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…

Certara2021 年 8 月 26 日

Case Study

Simcyp 年龄定义功能助力优化新生儿 Everolimus 给药方案

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

Certara2021 年 8 月 26 日

Case Study

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…

Certara2021 年 8 月 26 日

Case Study

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Certara2021 年 8 月 20 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…

Certara2021 年 8 月 12 日

Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

Certara2021 年 8 月 12 日

Case Study

使用 Simcyp Simulator 的 DDI 监管典范案例：Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…

Certara2021 年 7 月 29 日

Case Study

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…

Certara2021 年 7 月 14 日

Case Study

治疗镰状细胞病的 Voxelotor：无需任何临床研究，利用剂量预测模型进行 DDI 预测

In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…

Certara2021 年 7 月 14 日

Blog

确保抗体-药物偶联物开发最大概率获得成功的关键考虑事项

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…

Certara2021 年 7 月 8 日

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治疗领域

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Simcyp 年龄定义功能助力优化新生儿 Everolimus 给药方案

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

使用 Simcyp Simulator 的 DDI 监管典范案例：Ibrutinib (Imbruvica®)

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

治疗镰状细胞病的 Voxelotor：无需任何临床研究，利用剂量预测模型进行 DDI 预测

确保抗体-药物偶联物开发最大概率获得成功的关键考虑事项

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