PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Blog Post
Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating advanced melanoma. As in the best practice case of ibrutinib, we generally perform physiologically-based pharmacokinetic...
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Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data Blog Post
Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton, N.J., August 5, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today...
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Blog Post
In this case study, the sponsor’s closing of a manufacturing site required that one of its top-selling products be made at a different facility, triggering FDA to request they demonstrate...
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Blog Post
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare B-cell malignancies to market. The company leveraged FDA’s accelerated approval program; it was one of...
Strategic Planning and technology to support a rolling BLA submission under tight timelines Blog Post
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second submission we supported for this Sponsor in the overall partnership. The agile nature of the...
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta Blog Post
Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and the disease. In 2012, FDA approved Ivacaftor (Kalydeco®) for treatment of the underlying cause of...
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Blog Post
In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and...
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success Blog Post
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval…
