Tag: Simcyp
How to Revamp Your Approach to Conventional IVIVC Models
An IVIVC (in vitro-in vivo correlation) is a predictive mathematical model describing the relationship between the in vitro properties of a dosage form and the in vivo responses. Drug developers frequently find IVIVCs useful for a number of reasons: They can use dissolution tests as a surrogate for human bioequivalence (BE) studies. They can support … Continued
Use of Physiologically-based Pharmacokinetic (PBPK) Models to Support Canine Drug Product Development
Mechanistic In Vitro-In Vivo Extrapolation (IVIV_E) of Dissolution Within a PBPK Framework: Extrapolation of IR Danazol Dissolution in the USP-2 Paddle Apparatus to In Vivo Dissolution
Simcyp In Vitro (Data) Analysis (SIVA) Toolkit: Deciphering Dissolution Experiments and Translating Intrinsic Parameters into PBPK Models
Think Global, Act Local: Supporting Orphan Drug Development in NJ
You could say that I’m a Jersey Girl. Having lived all my life in the Garden State, it’s important to me to help give back to the New Jersey community that is home to our Princeton headquarters. So, I’m really proud that Certara has supported the approval of several orphan drugs for rare diseases, one … Continued
Towards Quantitative Prediction of Disease-drug Interactions Using a Physiologically-based Pharmacokinetic Modeling Approach: Suppression of CYP1A2 by IL-6
Extended Validation of a Peripheral Sampling Site in PBPK Modeling Using Clarithromycin, Dextromethorphan, Dextrorphan, Erythromycin, Lidocaine and Tramadol
Why Using In Silico Modeling for Cardiac Safety is the Next Big Thing
The sky high cost of drug development means that late stage drug attrition is especially devastating. Thus, the ability to assess potential drug safety issues early— using in vitro data— would be very beneficial. The current paradigm for cardiac safety pharmacology is rooted in the preclinical ICH S7B and clinical ICH E14 guidelines. There have … Continued
Dosing for Two: How Pharmacometrics Supports Drug Safety in Pregnancy
According to the US Census Bureau, there is a birth every eight seconds in the United States. Women frequently take prescription and over-the-counter drugs during pregnancy. Given the ubiquity of pregnancy and births, you’d think that there would be a robust understanding of the safety and efficacy of drugs in pregnant women. However, the vast … Continued