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Bioanalytical Services:
Strong scientific and regulatory knowledge in tandem with method development experts and experienced scientists who understand your need for timely and accurate communication allows Lambda to offer extensive bioanalytical services. Over
2000 samples are analysed each day at Lambda. The entire gamut of operations conforms to GLP and other relevant regulatory
guidelines.
The focus of bioanalysis is to provide
a quantitative measure of the active drug
and/or its metabolite(s). Samples may
be derived from biological matrices (plasma,
serum or urine etc). An appropriate bioanalytical
technique is required to make these measurements.
Selection of the correct technique may
depend on the required lower limit of
quantitation, the molecule's chemical
nature, molecular weight and structure.
Lambda’s 160-member strong team provides
in-depth bioanalytical services, which
can be applied throughout the clinical
development pathway. At Lambda we have
very well defined bioanalytical procedures
that primarily cover the following key
areas:
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Clinical sample separation and
storage |
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Preparation of calibration curve and quality control
samples |
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Defining acceptance criteria for successful
results |
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Chromatographic acceptance
criteria |
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Repeat analysis with decision
tree |
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Development and validation of bioanalytical
methods |
How do we at Lambda add value to our Bioanalytical services at Lambda?
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A
Bioanalytical lab, equipped with
the most sophisticated instruments
such as 20 LC-MS/MS and 10 HPLCs
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Equipped with
Scientific Data Management System, SDMS (Nugenesis) to enable the capturing of electronic bioanalytical data with audit
trail |
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Over
104 validated
Bioanalytical methods
and 34 are under
the process of development and validation |
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