What Is an ADME Study?
What Is an ADME Study? 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...
Navigating Compounding in Early Phase Drug Development and ADF Studies: Techniques, Regulatory Considerations, and Practical Approaches
Navigating Compounding in Early Phase Drug Development and ADF Studies: Techniques, Regulatory Considerations, and Practical Approaches Drug compounding, in the context of Phase 1 and early-phase drug development, is the process of preparing customized investigational...
FIH Studies: Tips and Tricks
FIH Studies: Tips and Tricks First-in-human (FIH) studies are a critical step in the development of new therapeutic interventions, providing the initial opportunity to assess their safety, tolerability, and pharmacokinetics in humans. However, these studies can pose...
Exploring the importance and ways to achieve Steady State in Pharmacokinetics
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)....
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