Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and … Continued
The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an approved (ie, reference) drug in their rate and extent of absorption. The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under … Continued
If ever there was a cautionary tale illustrating the importance of getting allometric scaling of drugs right, it’s the story of Tusko the elephant. In 1962, Tusko was living at the Lincoln Park Zoo in Oklahoma City where he received a dose of the psychomimetic drug, lysergic acid diethylamide, better known as LSD. The dose … Continued
According to the Council for Responsible Nutrition, a trade group for the $32 billion nutritional supplement industry, 68% of adults take dietary supplements. Further analysis shows that supplement use is more prevalent among women, the children of women that take supplements, and the elderly. Like drugs, supplements do not work the same in all patients … Continued
“Fundamentally, Certara is a collection of academic discoveries and scientific minds who are charged with transforming patient care and improving the most crucial research and development and regulatory decisions. Our training organization and methodology must be equally accountable for this mission.” – Edmundo Muniz I heard these inspiring words from our CEO during my first … Continued
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
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
