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Case Study

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

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

CertaraJuly 14, 2021

Blog

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

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

CertaraJuly 8, 2021

Video

Meet a Certara regulatory operations specialist

Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares…

CertaraJuly 2, 2021

Blog

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics.…

CertaraJune 25, 2021

Case Study

Complex patient profile and narrative template needs

A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative…

CertaraJune 24, 2021

Press Coverage

Fundamentals of regulatory writing: the document development process

Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…

CertaraJune 22, 2021

Blog

Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…

CertaraJune 22, 2021

Blog

Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers

This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence…

CertaraJune 18, 2021

Blog

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting

Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory…

CertaraJune 15, 2021

Brochure

Drive Impactful Science from Bench to Market

Learn how Certara drives impactful science.

CertaraJune 14, 2021

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Meet a Certara regulatory operations specialist

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

Complex patient profile and narrative template needs

Fundamentals of regulatory writing: the document development process

Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting

Drive Impactful Science from Bench to Market

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