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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

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2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale fo...

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18.0 Shipping stability: This section should provide information on shipping stability stu...

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17.0 In use stability: This section should provide information on in use stability studies...

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

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