'Ich q8' presentation slideshows

Ich q8 - PowerPoint PPT Presentation

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???????????????? QbD ??. ?????????? ??? chenguiliang@smda.gov.cn 13918584368 021-50798191. ??. ???????????? ???? ????????? ? QbD ??? QbD ?????????????? QbD ?? HPLC ? ???? ???????? QbD ??????. ???????????. ???? - ???? - ???? - ????????. US FDA. ICH Q6A ????. ???? ???? ?? ??

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725 views • 36 slides
A Bayesian Approach to the ICH Q8 Definition of Design Space

A Bayesian Approach to the ICH Q8 Definition of Design Space

A Bayesian Approach to the ICH Q8 Definition of Design Space. 2008 Graybill Conference, Fort Collins, Co. June 11 th -13 th , 2008. John J. Peterson Senior Director, Research Statistics Unit GlaxoSmithKline Pharmaceuticals john.peterson@gsk.com. Graphically accessible.

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669 views • 34 slides
A Bayesian Approach to the ICH Q8 Definition of Design Space

A Bayesian Approach to the ICH Q8 Definition of Design Space

A Bayesian Approach to the ICH Q8 Definition of Design Space. 2008 Graybill Conference, Fort Collins, Co. June 11 th -13 th , 2008. John J. Peterson Senior Director, Research Statistics Unit GlaxoSmithKline Pharmaceuticals john.peterson@gsk.com. Graphically accessible.

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519 views • 34 slides
Quality Risk Management ICH Q9 History

Quality Risk Management ICH Q9 History

Quality Risk Management ICH Q9 History. Disclaimer: This presentation includes the authors views on quality risk management theory and practice. The presentation does not represent official guidance or policy of authorities or industry. Purpose of this part is to:.

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233 views • 19 slides
ICH Quality Plenary Meeting

ICH Quality Plenary Meeting

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269 views • 17 slides
ICH Quality Topics Update

ICH Quality Topics Update

ICH Quality Topics Update. Moheb M. Nasr, Ph.D. Office of New Drug Quality Assessment (ONDQA), OPS, CDER Advisory Committee for Pharmaceutical Science (ACPS) October 5, 2006. Presentation . Topic Introduction Moheb Nasr, Ph.D., CDER, FDA

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PROCESS VALIDATION - ACTUAL REGULATION, PERFORMING AND INSPECTION

PROCESS VALIDATION - ACTUAL REGULATION, PERFORMING AND INSPECTION

PROCESS VALIDATION - ACTUAL REGULATION, PERFORMING AND INSPECTION. Eurasian Economic Commission?? decision ? 77 new revision. Annex 15 harmonization with EMA regulation Main idea : inclusion of the principles of ICH ( Q8, Q9, Q10 ) in Annex 15. ICH Q8 Pharmaceutical Development

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80 views • 7 slides

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