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REGULATORY AFFAIRS

Regulatory Affairs by Kara Daly. Challenges in developing NIR methods for release testing, assay and/or uniformity of content. October 17th, 2012. Currently the US Pharmacopeia monograph requires content uniformity tests to be performed on solid-dosage form samples at a frequency of 10 per batch. The FDA asserts that “quality cannot be tested into products, it should be built in or should be by design”. 1 US FDA Guidance for Industry PAT- A Framework for Innovative Pharmaceutical. October 17th, 2012.

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REGULATORY AFFAIRS | regulatory.ie Reviews

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Regulatory Affairs by Kara Daly. Challenges in developing NIR methods for release testing, assay and/or uniformity of content. October 17th, 2012. Currently the US Pharmacopeia monograph requires content uniformity tests to be performed on solid-dosage form samples at a frequency of 10 per batch. The FDA asserts that “quality cannot be tested into products, it should be built in or should be by design”. 1 US FDA Guidance for Industry PAT- A Framework for Innovative Pharmaceutical. October 17th, 2012.

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1 regulatory affairs

2 infrared ir radiation

3 references

4 posted in fda

5 hplc

6 radiation

7 no comments

8 posted in adrs

9 efficacy

10 emea

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REGULATORY AFFAIRS | regulatory.ie Reviews

https://regulatory.ie

Regulatory Affairs by Kara Daly. Challenges in developing NIR methods for release testing, assay and/or uniformity of content. October 17th, 2012. Currently the US Pharmacopeia monograph requires content uniformity tests to be performed on solid-dosage form samples at a frequency of 10 per batch. The FDA asserts that “quality cannot be tested into products, it should be built in or should be by design”. 1 US FDA Guidance for Industry PAT- A Framework for Innovative Pharmaceutical. October 17th, 2012.

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regulatory.ie

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NIR « REGULATORY AFFAIRS

http://www.regulatory.ie/category/nir

Regulatory Affairs by Kara Daly. Archive for the ‘NIR’ Category. Challenges in developing NIR methods for release testing, assay and/or uniformity of content. Wednesday, October 17th, 2012. Currently the US Pharmacopeia monograph requires content uniformity tests to be performed on solid-dosage form samples at a frequency of 10 per batch. The FDA asserts that “quality cannot be tested into products, it should be built in or should be by design”. You are currently browsing the archives for the NIR category.

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SUSARS « REGULATORY AFFAIRS

http://www.regulatory.ie/category/susars

Regulatory Affairs by Kara Daly. Archive for the ‘SUSARS’ Category. A discussion of the advantages and disadvantages of the different methods used in pharmacovigilance. Wednesday, October 17th, 2012. Post receipt of marketing authorisation, adverse reports are required to be submitted as Individual Case Safety Reports (ICSRs) within specified timelines. A serious unexpected ADR must be reported within 10 working days of receipt. 1 Volume 10 Eudralex Clinical trials guidelines. 2 ICH Topic E 2 A. Clin...

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Safety « REGULATORY AFFAIRS

http://www.regulatory.ie/category/safety

Regulatory Affairs by Kara Daly. Archive for the ‘Safety’ Category. A discussion of the advantages and disadvantages of the different methods used in pharmacovigilance. Wednesday, October 17th, 2012. Post receipt of marketing authorisation, adverse reports are required to be submitted as Individual Case Safety Reports (ICSRs) within specified timelines. A serious unexpected ADR must be reported within 10 working days of receipt. 1 Volume 10 Eudralex Clinical trials guidelines. 2 ICH Topic E 2 A. Clin...

4

PSURs « REGULATORY AFFAIRS

http://www.regulatory.ie/category/psurs

Regulatory Affairs by Kara Daly. Archive for the ‘PSURs’ Category. A discussion of the advantages and disadvantages of the different methods used in pharmacovigilance. Wednesday, October 17th, 2012. Post receipt of marketing authorisation, adverse reports are required to be submitted as Individual Case Safety Reports (ICSRs) within specified timelines. A serious unexpected ADR must be reported within 10 working days of receipt. 1 Volume 10 Eudralex Clinical trials guidelines. 2 ICH Topic E 2 A. Clini...

5

ADRs « REGULATORY AFFAIRS

http://www.regulatory.ie/category/adrs

Regulatory Affairs by Kara Daly. Archive for the ‘ADRs’ Category. A discussion of the advantages and disadvantages of the different methods used in pharmacovigilance. Wednesday, October 17th, 2012. Post receipt of marketing authorisation, adverse reports are required to be submitted as Individual Case Safety Reports (ICSRs) within specified timelines. A serious unexpected ADR must be reported within 10 working days of receipt. 1 Volume 10 Eudralex Clinical trials guidelines. 2 ICH Topic E 2 A. Clinic...

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Regulatory Affairs by Kara Daly. Challenges in developing NIR methods for release testing, assay and/or uniformity of content. October 17th, 2012. Currently the US Pharmacopeia monograph requires content uniformity tests to be performed on solid-dosage form samples at a frequency of 10 per batch. The FDA asserts that “quality cannot be tested into products, it should be built in or should be by design”. 1 US FDA Guidance for Industry PAT- A Framework for Innovative Pharmaceutical. October 17th, 2012.

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