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FDA Puiblish Guidance on Q4B, Evaluation and Recommendation of Pharmacopoeial Text for Use in ICH regions, Annex 12 Analytical Sieving General Chapter

admin — Thu, 23 Sep 2010 11:45:58 +0000

FDA Publish Guidance on Q4B, Evaluation and Recommendation of Pharmacopoeial Text for Use in ICH regions, Annex 12 Analytical Sieving General Chapter.

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This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.3
This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter

admin — Wed, 22 Sep 2010 11:41:14 +0000

FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter.

Full Text Here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

admin — Thu, 06 May 2010 06:45:50 +0000

Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

Full Text Here

This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

admin — Wed, 05 May 2010 06:41:23 +0000

Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

full text here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Dissolution Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

admin — Tue, 04 May 2010 06:40:43 +0000

Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

Full Text Hear

This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

admin — Fri, 08 Jan 2010 07:35:23 +0000

Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

Full Text Here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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