Bioequivalence Studies and Complex Generics Global medicine spending is projected to be significantly increased close to 2 trillion by 2027 with the annual increase rate from 3 to 6%. And that figure excludes the impact of COVID-19 therapeutics and vaccines. The...
Reasons and Solutions for Multiple Peaking Phenomena in Pharmacokinetics Studies In this blog, we provide a brief overview of the multiple peaks in pharmacokinetics studies, how to handle and the potential impact on study outcomes. In the pharmacokinetics...
Mastering Clinical Trial Documentation: Understanding the TMF and the ISF in Clinical Research In clinical research, careful and organized documentation is crucial to maintaining trial integrity and participant safety. Essential documents encompass a range of...
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....
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