An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters (Cmax, AUC) from in vitro dissolution data. Drug developers use IVIVCs for 3 major reasons: To serve as a surrogate for human bioequivalence (BE) studies To support and/or validate the use of dissolution methods and specifications To assist in quality … Continued
Did you know that 84% of the 4 billion prescriptions written each year are for generic drugs? Clearly, generics are a big business. Regulatory agencies, such as the FDA, require generic drug manufacturers to show that generic drugs are bioequivalent to the reference drug. Bioequivalence (BE) studies can also be required for pharmaceutical variations made … Continued
A study by the FDA Office of Generic Drugs (OGD) reviewed over 1000 bioequivalence (BE) studies of 180 drugs, of which over 30% were highly variable (HV). Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of … Continued
Nelson Mandela is quoted with saying, “Education is the most powerful weapon which you can use to change the world.” At Certara, we are helping change the world by aiding the development of novel medications through our technology-enabled solutions. Indeed, supporting the education of the next generation of pharmacometricians is essential to our mission. In … Continued
Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation (M&S) is an important tool that can help researchers gain a better understanding of their drug’s efficacy— especially at the early stages of drug development. In this blog post, I’ll discuss some positive statistics uncovered in a recent IQ Consortium survey that examined the current landscape for preclinical PK/PD modeling … Continued
One of the most rewarding parts of leading Certara’s consulting services is recognizing how our work supports new drug approvals to positively impact patients’ health. In this blog post, I’ll discuss how Certara helped Cubist obtain FDA approval for Zerbaxa™ (ceftolozane/tazobactam), a new antibacterial drug to treat adults with complicated infections. The growing threat of … Continued
Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug. To satisfy regulatory expectations, these computer systems should be validated. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data … Continued
As a scientist at Certara and proud Dad to my three kids, pediatric drug development is a topic that is near to my heart. Clearly, children are not just “small adults.” They require special consideration for their distinct physiology during drug development. Likewise, for ethical reasons, it is important to minimize children’s exposure to experimental … Continued
As the manager of scientific communication for Certara, part of my job is to educate new and existing clients on the ways they can maximize their utilization of Certara’s software and consulting services. Therefore, it was important for me, early on, to experience our training solutions to better understand our clients’ perspectives. At Certara, we … Continued
Have you heard the FDA will require electronic submissions that use CDISC standardized study data? In my work at Certara, I’ve noticed there’s a lot of confusion, and even significant apprehension, surrounding this issue. To combat the misconceptions about what these regulations will mean for drug developers, I’ve compiled a list of common questions (and … Continued
