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7.0 Analytical Studies: The statements and descriptions in the following sections refer to...

2023-10-03T05:22:57

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ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs...

2023-10-26T11:12:10

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ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs...

2023-10-25T05:12:59

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6. However, accelerated approval should be used for a drug that represent significant adva...

2023-10-28T05:47:30

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6.3 Infrastructure The organisation shall determine, provide and maintain the infrastructu...

2023-10-11T04:46:54

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4.2.3 Control of documents : Documents required by the quality management system shall be ...

2023-10-10T04:32:42

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As part of design and development validation, the manufacturer shall perform clinical eval...

2023-11-04T06:17:57

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10.As provided in the rules, surrogate marker should be considered as an interim data poin...

2023-10-28T05:49:20

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7.3.6 Design and development validation: Design and development validation shall be perfor...

2023-10-13T05:21:41

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