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Explanation : Interference studies involve adding the potential interferent to the sample...

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10.0 Analytical sensitivity: This section should include information about the study desig...

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As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices...

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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14.0 Definition of Assay Cut-off: This section should provide a summary of analytical data...

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