This book introduces the students to the significance of analyzing drugs in biological matrices such as blood, plasma, and urine. It addresses the properties and challenges of working with biological media like peptides, metabolites, and prodrugs. The course covers the principles of good clinical practice (GCP) and international guidelines from ICH and ICMR. Emphasis is laid on proper documentation and auditing practices to ensure GCP compliance.
Students learn about USFDA and UDSCO guidelines for conducting bioavailability/ bioequivalence (BA/BE) studies. It includes designing and executing BA/BE studies with attention to sample handling and record keeping. The course explores various drug extraction methods, including protein precipitation and liquid–liquid extraction. Advanced techniques such as solid-phase extraction and membrane filtration are also studied. Analytical methods like HPLC, LC-MS/MS, and gel electrophoresis are taught for separating biomolecules.
The book provides both theoretical and practical knowledge of validated bioanalytical methods essential for pharmaceutical research and regulatory approval.
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