Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage of new drug approvals including PBPK analyses in 2019 [1]. Another paper showed a rise of more than 280% in pharmaceutical applications of PBPK M&S … Continued
In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting virtual bioequivalence IVIVE-PBPK in biopharmaceutics An quantitative risk assessment approach for virtual bioequivalence Role of inter-occasion variability and pharmacokinetic properties in virtual bioequivalence
As model‐informed drug development becomes an integral part of modern approaches to the discovery of new therapeutic entities and showing their safety and effectiveness, modalities of incorporating the paradigm into widespread practice require a revisit. Traditionally, modeling and simulation (M&S) have been performed by specialized teams who (…)
Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimise and replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidances on paediatrics. Best practice standards were … Continued
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for genericdrug approval. As a result, some branded drugs remain on the market well pastthe originator’s patent expiration, without cost-effective generic alternatives thatcould benefit patients. Model-informed drug development (MIDD), specificallyphysiologically-based pharmacokinetics (PBPK) leveraging in vitro data, is a proven,cost-effective option to consider in lieu of running an … Continued
A successful drug product must demonstrate drug substance viability, clinical viability, and economic viability. Drug developers typically use a range of software tools to help demonstrate the viability of their products in these domains. In this product theatre, Drs. Hannah Jones and Keith Nieforth will explain how Certara’s products and services can help accelerate the … Continued
The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of … Continued
250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.” This is the language typically used by the US FDA on drug labels to describe how clinical pharmacology decisions have been reached. Much more detail can be found in the Office of Clinical Pharmacology (OCP) review that supports … Continued
• The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment (RI) and hepatic impairment (HI) populations was evaluated using clinical data from 29 compounds with 106 organ impairment study arms were collected from 19 member companies of the International Consortium for Innovation and Quality in Pharmaceutical Development. Fifty RI and … Continued
