Computer Systems Validation (CSV) is a process that ensures computer systems, including software and hardware, used in regulated industries such as pharmaceuticals, medical devices, and finance are fit for purpose and meet regulatory requirements. CSV's goal is to...
In recent years, RNA-targeted therapies have emerged as a promising frontier in the world of medicine. By harnessing the power of RNA, these innovative treatments have the potential to revolutionize how we treat a wide array of genetic diseases. As a leading Phase 1...
Good Documentation Practice (GDP) is a set of guidelines and procedures established to create, review, approve, distribute and maintain documentation within regulated industries such as pharmaceuticals, healthcare and manufacturing. The guidelines for GDP were created...
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 characteristics of the body, such as...
In the realm of pharmaceutical research and development, ensuring the safety and efficacy of drugs is of paramount importance. Bioequivalence (BE) studies play a crucial role in this process for generic drug development, and regulatory bodies like the Brazilian Health...
The pharmacokinetic properties of a new chemical entity (NCE) or an investigational medicinal product (IMP) must be elucidated during clinical drug development. This includes the analysis of their absorption, distribution, metabolism, and excretion (ADME) and is...
