Obeticholic Acid – From PK Model to Drug Label

Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.

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Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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How to Expedite FDA Approvals of Orphan Drugs

Thomas Peyret

350 million patients worldwide suffer from 7,000 rare diseases, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of rare disease patients, represents a huge unmet medical need. Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patients are difficult to identify […]

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Topics: PK/PD Modeling & Simulation

Understanding the Relationship between Systemic and Hepatic Exposure of Obeticholic Acid for the Treatment of Liver Disease in Patients with Cirrhosis

Obeticholic acid (OCA) is a selective and potent farnesoid X receptor (FXR) agonist in development for several chronic liver diseases. OCA is a semi-synthetic analogue of chenodeoxycholic acid (CDCA) with similar pharmacokinetic (PK) properties. There was a significant increase in systemic exposure of OCA in patients with hepatic impairment. A proportionally similar increase in systemic […]

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Rare Disease and Orphan Drug Development

There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of those suffering from rare diseases, represents a huge unmet medical need. Modeling and simulation approaches are not only ideal for the development of drugs for rare diseases, but are encouraged by regulators.

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Informing Pediatric Drug Development: A Selection from Certara’s Best of Blogs

A selection of short essays by Certara’s pediatric drug development experts. Learn about our technologies and strategies for pediatric drug development to inform dose selection, including PK/PD simulations using sparse data analysis and our Simcyp Pediatric Simulator. Certara’s regulatory writing consultancy, Synchrogenix, also offer regulatory strategy for pediatrics.

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Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success

The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current approach to pediatric drug development. Biosimulation is a proven approach that will help optimize trial design and inform the drug label. This approach can support global regulatory strategies that increase the likelihood of success for pediatric drug development programs.

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Conducting Virtual Trials Using PBPK to Drive More Precise Label Claims

Biosimulation technology is revolutionizing the way in which the pharmaceutical industry does business and how the regulators are reviewing new drug approvals. Biosimulation leverages both empirical analysis of clinical data and mechanistic in silico approaches. The latter approach encompasses both in vitro-in vivo extrapolation (IVIVE) and physiologically-based pharmacokinetic modeling and simulation (PBPK M&S).

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PBPK Modeling in Regulatory Review, Product Labeling and Safety Monitoring

Physiologically-based pharmacokinetic (PBPK) modeling can address various questions raised in drug development and regulatory review, and is used most extensively to predict and quantify the extent of drug-drug interactions (DDIs) from both in vitro and clinical data. This assists with dose selection and the design of clinical studies as well as informing decisions relating to […]

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Learning From Failure, Leveraging Modeling and Simulation for Pediatric Drug Development Success

Historically, clinical trials have not examined most pediatric medications. This is due to the ethical and practical challenges of conducting pediatric drug trials. Children are 40 percent of the world’s population. Yet, regulatory agencies have approved only 10 percent of the drugs on the market for pediatrics.1 Without a proper clinical process, pediatricians are stuck […]

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Understanding Complex PK

Physiologically-based modeling and simulation explained unusual PK and helped an orphan drug achieve approval based on small clinical studies. In rare diseases, with few patients available for clinical study, every data point becomes crucial to understanding a potential therapy’s benefit-risk profile. Model-based methods can help by gathering disparate information sources into a cohesive picture of […]

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Learning from One Indication to the Next

Application of modeling and simulation to support the regulatory approval of a monoclonal antibody based on small clinical trials and evidence from a previous indication. In some cases, information gained during developing a drug for one indication can be leveraged to support approval for a different indication. PNH (paroxysmal nocturnal hemoglobinuria) is a rare, progressive, […]

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Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting in low renal maximum threshold for phosphate reabsorption, low serum phosphate (Pi) and 1,25-dihydroxyvitamin D levels with subsequent development of short stature and skeletal deformities. KRN23 is a novel human anti-FGF23 antibody for the treatment of XLH. The pharmacokinetics (PK) […]

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Precision Dosing Using PBPK Modeling

Precision dosing― the right dose, for the right patient, at the right time― is crucial to providing patients with the most efficacious medications with minimal probability of adverse events. One key step towards achieving the delivery of individualized dosing is testing potential dosing regimens in a patient’s ‘virtual twin.’ The other key step is to […]

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