Bioanalytical Services
Table of Contents
Introduction
Kshetra Analyticals’ bioanalytical laboratory is equipped with state-of-the-art liquid chromatography and tandem mass spectrometry (LCMSMS) technology, allowing us to provide a wide range of bioanalytical services to our clients. Our experienced team of scientists is dedicated to providing accurate and reliable results, and our quality control measures ensure that our data meets regulatory requirements.
Services Offered
Method Development:
Our team is experienced in developing and optimizing bioanalytical methods for a variety of sample matrices, including plasma, serum, urine, and tissues. We use a variety of extraction techniques to ensure that our methods are sensitive and selective.
Method Validation:
We validate all bioanalytical methods according to regulatory guidelines to ensure that they are accurate, precise, and reproducible. We use a variety of parameters to assess method performance, including selectivity, linearity, sensitivity, precision, accuracy, and stability.
Study Sample Analysis:
We provide bioanalytical support for all phases of drug development, from discovery to post-marketing. Our team is experienced in analyzing samples from clinical trials and preclinical studies, including pharmacokinetic, and biomarker analysis.
Bioavailability and Bioequivalence (BA/BE) Studies:
Our BA/BE center supports clinical research during the product development stage by conducting BA/BE studies. We provide services for both generic and innovator drugs, and our BA/BE studies are conducted in accordance with regulatory guidelines.
Bioanalytical Monitoring/Auditing Services:
We provide third party Monitoring and Auditing services for the Bioanalytical phase of BA/BE Studies.
- In process Bio analytical Monitoring.
- Retrospective Bio analytical Auditing.
Other Bioanalytical Services:
In addition to the services listed above, we also offer other bioanalytical services, such as metabolite profiling, in vitro drug metabolism studies, and impurity identification.
Conclusion:
At Kshetra Analyticals, we are committed to providing our clients with high-quality, reliable bioanalytical services. Our experienced team of scientists, state-of-the-art technology, and quality control measures ensure that our data meets regulatory requirements and our clients’ needs. Contact us today to learn more about our bioanalytical services.