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| Bioanalytical Support
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AniClin's Divisional Bioanalytical Chemistry team supports the growing demand in the Pharmaceutical and Biotech industries. These services are provided as a stand alone service or in support of full preclinical programs. Our GLP compliant operations are equipped to analyze biological samples for drug candidates and metabolites in biological matrices such as blood, plasma, urine, dialysate and tissues to support preclinical drug safety, metabolism research and PD and PK studies.
AniClin's experienced scientists are capable of rapidly solving complex bioanalytical projects by developing and validating robust quantitative methods including cross-species and cross-matrix methods and applying those methods to high throughput sample analysis.
AniClin's breadth of technology and scientific expertise, rigorous cGXP compliance programs and our persistence to satisfy Sponsors' needs give Sponsors high quality data and fast turn-around.
Services Overview:
- Methods development and validation
- Study sample analysis
- LC/MS/MS
- HPLC
- Quality assurance process with GLP compliance
- Bioanalytical Protocol design and Protocol writing
- Study plans based upon on the latest regulatory guidelines
Capabilities:
- Estimates of sensitivity, linearity, separation and specificity can be determined quickly prior to full method development and validation
- Preliminary methods can be developed and qualified prior to full validation for pilot studies or preclinical animal studies
- Full validations are done according to Good Laboratory Practices (GLP), FDA guidance and Azopharma SOPs to ensure that an assay has demonstrated linearity, recovery, reproducibility, specificity, accuracy and stability
- Low-level analysis of drugs and metabolites in complex biological matrices
- High sample throughput
- LC/MS/MS instruments
- Automated sample preparation
- Conventional HPLC (UV-Visible, fluorescence, and electrochemical detection)
- Analysis of unconventional biological tissues
- Low temperature storage (-20° and -80° C freezer capacity)
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