Bioanalytical Testing

Bioanalytical testing plays a crucial role in drug development by providing quantitative data on drug concentrations in biological matrices like plasma, serum, urine etc. This helps establish whether a drug is safe and effective for human use. Such testing is carried out by Contract Research Organizations (CROs) and labs that offer specialized bioanalytical testing services.

Validation as per Regulatory Guidelines

For the generated data to be accepted by regulatory agencies, the Bioanalytical Testing Services methods need to be thoroughly validated as per international standards. The key validation parameters include selectivity, lower limit of quantification, precision, accuracy, recovery, matrix effect and stability. Adherence to validation guidelines is essential for obtaining approvals for clinical trials and product licensing. Experienced CROs meticulously validate all methods as per FDA, EMA and other global regulatory requirements.

Sample Analysis and Method Development

The first step in any bioanalytical study is sample analysis where biological samples collected during preclinical and clinical studies are tested for drug concentration levels. Sophisticated analytical techniques like LC-MS/MS and immunoassays are used for this purpose. Method development is also a key service where customized and validated methods are created to accurately quantify drugs and their metabolites in complex matrices. This ensures reproducible and reliable results during sample analysis.

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