Understanding the Roles of Operations and Quality in a CRO In Clinical Research, as in most things in life, balance is key. An even balance between clinical operations and clinical quality assurance is essential to the success of any clinical trial, not just during...
PBPK Modeling in Predicting Drug Behavior Physiologically-based pharmacokinetic (PBPK) is a mathematical modeling approach used in pharmacology and toxicology to predict the behavior of drugs in the body. PBPK models take into account the physiological and biochemical...
Navigating ANVISA’s Requirements: A Guide to Performing and Analyzing Bioequivalence Studies for the Brazilian Health Authority In the realm of pharmaceutical research and development, ensuring the safety and efficacy of drugs is of paramount importance....
ANOVA: The conventional method vs the mixed model Abstract: In this paper, we provide a brief review of conventional ANOVA and its counterpart mixed model. We provide a comparison of the two models and briefly discuss the models recommended by the agencies. Analysis...
Exploring the importance and ways to achieve Steady State in Pharmacokinetics An Introduction to Multiple-dose Study Dose and dose regimen are some of the features that need to be determined first when designing a clinical trial for an investigational product (IP)....
Drug Development Pathway for New & Generic Narrow Therapeutic Index Drugs Drug development is a complex and intricate process that involves a significant amount of time, effort, and resources. One area of drug development that requires particular attention is the...
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