Bioanalysis

       The purpose of bioanalytical method development is to determine that the design, operating conditions, limitations, and applicability of the methods meet expected goals, and to ensure that the methods are optimized.  

       In the development of new methods for bioactivity analysis, considering the complex properties and strict similarity indicators of new active pharmaceutical ingredients (APIs) or biosimilarities, it is necessary to introduce statistical methods to provide reliable data intervals and new solutions for the development and application of procedural methods.

       Bioanalytical Method Validation refers to the quantitative analysis of target substances in biological matrices using techniques such as chromatography (CC) or chromatography-mass spectrometry and ligand binding assay (LBA). The target substance mainly refers to large molecules such as proteins and peptides, or small molecules such as drugs and metabolites. These target substances exist in biological matrices or biological samples, such as blood, plasma, serum, urine, saliva, cerebrospinal fluid, and other organ tissues.  

       The purpose of validating biological analytical methods is to demonstrate that the method is suitable for its intended use. Due to the special characteristics of biological matrices (complex composition, large variation between individuals) and the fact that bioanalysis involves a series of complex processes (including sample collection and storage, sample pre-treatment, sample injection and analysis, and data analysis), it is necessary to prove that a bioanalytical method provides reliable and reproducible results for the target substances measured in a particular biological matrix. Only validated analytical methods can provide critical data to support the safety and efficacy of drugs and biologics.  

       A bioanalytical method includes the following key characteristics: selectivity, lower limit of quantification, response function and corrected range (standard curve performance), accuracy, precision, matrix effects, and stability of the analyte throughout storage and handling in biological matrices and solutions. Method validation for quantitative analysis of biological samples and analysis of test samples should be in accordance with the technical requirements. GLP principles or GCP principles should be observed in the biological sample analysis.