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...
Clinical Drug Development and European Sponsors Efforts to Harmonize Regulatory Requirements The drug development process is constantly evolving and incorporating advances in scientific research, including progress in personalized medicine and big data use. However,...
Understanding Hepatic Impairment Pharmacokinetic Studies in Drug Development Hepatic drug metabolism involves enzymatic reactions, including oxidation, reduction, and hydrolysis, which modify the drug q molecule and make it more water-soluble, allowing it to be...
Clinical Study Report Development: Bioequivalence-Generic Products As a drug development sponsor, you know that creating a Clinical Study Report (CSR) is a critical part of the drug development process. It is a crucial component for regulatory agencies when...
Insights into Clinical Research: Effective Strategies for Study Participant Recruitment & Retention In the world of clinical research, accelerated drug development can be a tedious process, taking over 10 years for medications to get to market. From bench to...
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