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AZD9291 in EGFR Inhibitor–Resistant Non–Small-Cell Lung Cancer

The New England journal of medicine, 2015-04, Vol.372 (18), p.1689-1699

2015

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In vitro models for the prediction of in vivo performance of oral dosage forms

European journal of pharmaceutical sciences, 2014-06, Vol.57, p.342-366

2014

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Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies

Cancer chemotherapy and pharmacology, 2016-04, Vol.77 (4), p.767-776

2016

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The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib

British journal of clinical pharmacology, 2018-06, Vol.84 (6), p.1156-1169

2018

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The effects of pharmaceutical excipients on drug disposition

Advanced drug delivery reviews, 2007-12, Vol.59 (15), p.1482-1503

2007

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Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin

British journal of clinical pharmacology, 2018-12, Vol.84 (12), p.2877-2888

2018

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Oral bioavailability of cinnarizine in dogs: Relation to SNEDDS droplet size, drug solubility and in vitro precipitation

European journal of pharmaceutical sciences, 2013-01, Vol.48 (1-2), p.339-350

2013

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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Pharmaceutics, 2022-05, Vol.14 (5), p.1010

2022

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Clinical Relevance of Dissolution Testing in Quality by Design

The AAPS journal, 2008-06, Vol.10 (2), p.380-390

2008

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Metabolic Disposition of Osimertinib in Rats, Dogs, and Humans: Insights into a Drug Designed to Bind Covalently to a Cysteine Residue of Epidermal Growth Factor Receptor

Drug metabolism and disposition, 2016-08, Vol.44 (8), p.1201-1212

2016

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Determining bioequivalence possibilities of long acting injectables through population PK modelling

European journal of pharmaceutical sciences, 2022-12, Vol.179, p.106296-106296, Article 106296

2022

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The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non‐Small‐Cell Lung Cancer and in Healthy Volunteers

Journal of clinical pharmacology, 2018-04, Vol.58 (4), p.474-484

2018

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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Journal of pharmaceutical sciences, 2021-02, Vol.110 (2), p.594-609

2021

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Exploring a model-based analysis of patient derived xenograft studies in oncology drug development

PeerJ (San Francisco, CA), 2021-01, Vol.9, p.e10681-e10681, Article e10681

2021

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Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

The AAPS journal, 2020-12, Vol.23 (1), p.7-7, Article 7

2020

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An Investigation into the Utility of a Multi-compartmental, Dynamic, System of the Upper Gastrointestinal Tract to Support Formulation Development and Establish Bioequivalence of Poorly Soluble Drugs

The AAPS journal, 2012-06, Vol.14 (2), p.196-205

2012

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Population PK modelling as an alternative route to bioequivalence

British Journal of Pharmacy, 2022-11, Vol.7 (2), p.S1-S2

2022

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The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

Journal of pharmaceutical sciences, 2014-11, Vol.103 (11), p.3377-3397

2014

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Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Journal of pharmaceutical sciences, 2016-11, Vol.105 (11), p.3243-3255

2016

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Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

The AAPS journal, 2010-09, Vol.12 (3), p.465-472

2010

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Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

The AAPS journal, 2012-09, Vol.14 (3), p.627-638

2012

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An investigation into the influence of drug lipophilicity on the in vivo absorption profiles from subcutaneous microspheres and in situ forming depots

Journal of controlled release, 2007-09, Vol.122 (1), p.79-85

2007

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Regulatory Biopharmaceutics

Biopharmaceutics, 2021, p.147-163

2021

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Abstract GS3-10: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

Cancer research (Chicago, Ill.), 2022-02, Vol.82 (4_Supplement), p.GS3-10-GS3-10

2022

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Abstract P1-18-10: A clinical study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced triple negative breast cancer (TNBC)

Cancer research (Chicago, Ill.), 2022-02, Vol.82 (4_Supplement), p.P1-P1-18-10

2022

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AZD9291 in EGFR Inhibitor–Resistant Non–Small-Cell Lung Cancer

In vitro models for the prediction of in vivo performance of oral dosage forms

Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies

The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib

The effects of pharmaceutical excipients on drug disposition

Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin

Oral bioavailability of cinnarizine in dogs: Relation to SNEDDS droplet size, drug solubility and in vitro precipitation

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Clinical Relevance of Dissolution Testing in Quality by Design

Metabolic Disposition of Osimertinib in Rats, Dogs, and Humans: Insights into a Drug Designed to Bind Covalently to a Cysteine Residue of Epidermal Growth Factor Receptor

Determining bioequivalence possibilities of long acting injectables through population PK modelling

The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non‐Small‐Cell Lung Cancer and in Healthy Volunteers

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Exploring a model-based analysis of patient derived xenograft studies in oncology drug development

Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

An Investigation into the Utility of a Multi-compartmental, Dynamic, System of the Upper Gastrointestinal Tract to Support Formulation Development and Establish Bioequivalence of Poorly Soluble Drugs

Population PK modelling as an alternative route to bioequivalence

The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

An investigation into the influence of drug lipophilicity on the in vivo absorption profiles from subcutaneous microspheres and in situ forming depots

Regulatory Biopharmaceutics

Abstract GS3-10: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

Abstract P1-18-10: A clinical study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced triple negative breast cancer (TNBC)

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