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Process analytical technology
Results: 90

#	Item
51	Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-05 09:20:34 Quality Clinical research Design for X Process analytical technology Quality by Design Food and Drug Administration Quality management system Center for Drug Evaluation and Research Validation Pharmaceutical sciences Pharmaceutical industry Pharmacology
52	. AMGEN Amgen One Amzen Center Drive [removed] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:23:29 Quality Clinical research Validity Validation Food and Drug Administration Specification Amgen Process analytical technology Pharmaceutical sciences Pharmaceutical industry Pharmacology
53	November 05,2003 Suite[removed]Bethesda Metro Center Bethesda, MD[removed]USA Tel: ([removed] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:23:29 Science Pharmaceutics Validity Clinical research Validation Process analytical technology Specification Food and Drug Administration Software development process Pharmaceutical industry Quality Pharmaceutical sciences
54	yen Squi WorMwide Medicines Group November 3,2003 Dockets Management Branch Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:23:28 Pharmaceutical industry Bristol-Myers Squibb Food and Drug Administration Pharmaceuticals policy Title 21 CFR Part 11 Didanosine Medical device Process analytical technology Validation Medicine Pharmaceutical sciences Pharmacology
55	DOC Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:28:56 Science Pharmaceutical sciences Validity Clinical research Validation Process analytical technology Specification Food and Drug Administration Software development process Pharmaceutical industry Technology Quality
56	QbD Considerations for Analytical Methods - FDA Perspective IFPAC Annual Meeting Baltimore, January 25, 2013 Sharmista Chatterjee, Ph.D. Add to Reading List Source URL: www.fda.gov Language: English QBD Science Pharmaceutical industry Electronics Knowledge Quality Process analytical technology Methodology Software development process Software engineering
57	Preliminary feedback on Lessons learnt from EU-FDA QbD pilot Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Process analytical technology Pharmaceutical sciences Pharmaceutical industry Clinical research
58	Federal Institute for Drugs and Medical Devices Challenges of Implementation of ICH Q 8 A Regulatory Perspective Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 04:07:15 Technology Medical device Federal Institute for Drugs and Medical Devices Quality by Design Federal Ministry of Health Process analytical technology Food and Drug Administration Regulatory requirement Medicine Pharmaceutical industry Health
59	A Regulatory Perspective on NIR Method Robustness Yubing Tang, Ph.D. FDA/CDER/ONDQA IFPAC, Baltimore MD Add to Reading List Source URL: www.fda.gov Language: English Knowledge Quality control Validity Spectroscopy Cheminformatics Process analytical technology Validation Near-infrared spectroscopy Chemometrics Science Pharmaceutical industry Chemistry
60	Multivariate Tools for Modern Pharmaceutical Control – FDA Perspective IFPAC Annual Meeting 22 January 2013 Christine M. V. Moore, Ph.D. Add to Reading List Source URL: www.fda.gov Language: English Computational chemistry Regression analysis Econometrics Chemometrics Multivariate analysis Process analytical technology Partial least squares regression Linear regression Principal component analysis Statistics Statistical methods Multivariate statistics

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