质量源于设计 (Chinese Wikipedia)

Analysis of information sources in references of the Wikipedia article "质量源于设计" in Chinese language version.

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18web.archive.org

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7ich.org

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5doi.org

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5fda.gov

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3nih.gov

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2qualitydigest.com

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1archive.today

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1sciencedirect.com

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archive.org

Herman GA; Stevens C, Van Dyck K, Bergman A, Yi B, De Smet M, Snyder K, Hilliard D, Tanen M, Tanaka W, Wang AQ, Zeng W, Musson D, Winchell G, Davies MJ, Ramael S, Gottesdiener KM, Wagner JA. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005-12, 78 (6): 675–88. PMID 16338283. doi:10.1016/j.clpt.2005.09.002.

archive.today

Roadmap for implementation of quality by design (QbD) for biotechnology products

doi.org

Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, United States; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality. International Journal of Pharmaceutics. 2016, 515: 390–402. doi:10.1016/j.ijpharm.2016.10.038.
Herman GA; Stevens C, Van Dyck K, Bergman A, Yi B, De Smet M, Snyder K, Hilliard D, Tanen M, Tanaka W, Wang AQ, Zeng W, Musson D, Winchell G, Davies MJ, Ramael S, Gottesdiener KM, Wagner JA. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005-12, 78 (6): 675–88. PMID 16338283. doi:10.1016/j.clpt.2005.09.002.
Evans SS, Clemmons AB. Obinutuzumab: A Novel Anti-CD20 Monoclonal Antibody for Chronic Lymphocytic Leukemia. Journal of the Advanced Practitioner in Oncology. 2015, 6 (4): 370–4. PMC 4677809 . PMID 26705497. doi:10.6004/jadpro.2015.6.4.7.
Cameron F, McCormack PL. Obinutuzumab: first global approval. Drugs. January 2014, 74 (1): 147–54. PMID 24338113. S2CID 40983655. doi:10.1007/s40265-013-0167-3.

fda.gov

Pharmaceutical Quality for the 21st Century: A Risk-Based Approach https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm128080.htm （页面存档备份，存于互联网档案馆）
Process Validation: General Principles and Practices (PDF). FDA Guidance. 2019-06-05 [2023-05-16]. （原始内容存档 (PDF)于2009-09-16）.
Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report Share Tweet Linkedin Email Print Department of Health and Human Services U.S. Food and Drug Administration. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report Share Tweet Linkedin Email Print. U.S. FDA. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report Share Tweet Linkedin Email Print Department of Health and Human Services U.S. Food and Drug Administration. [2023-05-17]. （原始内容存档于2023-05-17）.
FDA Approves New Treatment for Diabetes （页面存档备份，存于互联网档案馆） 2006-10-17.
Department of Health and Human Services U.S. Food and Drug Administration. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report. [2023-05-17]. （原始内容存档于2023-05-17）.

ich.org

PHARMACEUTICAL DEVELOPMENT Q8(R2) (PDF). [2023-05-16]. （原始内容存档 (PDF)于2011-05-16）.
QUALITY RISK MANAGEMENT Q9 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2011-05-16）.
PHARMACEUTICAL QUALITY SYSTEM Q10 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2011-05-15）.
DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2012-07-11）.
TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT Q12 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2019-06-06）.
ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products dated 14 November 2018 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2019-06-06）.
ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation dated 14 November 2018 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2019-06-06）.

nih.gov

ncbi.nlm.nih.gov

Herman GA; Stevens C, Van Dyck K, Bergman A, Yi B, De Smet M, Snyder K, Hilliard D, Tanen M, Tanaka W, Wang AQ, Zeng W, Musson D, Winchell G, Davies MJ, Ramael S, Gottesdiener KM, Wagner JA. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005-12, 78 (6): 675–88. PMID 16338283. doi:10.1016/j.clpt.2005.09.002.
Evans SS, Clemmons AB. Obinutuzumab: A Novel Anti-CD20 Monoclonal Antibody for Chronic Lymphocytic Leukemia. Journal of the Advanced Practitioner in Oncology. 2015, 6 (4): 370–4. PMC 4677809 . PMID 26705497. doi:10.6004/jadpro.2015.6.4.7.
Cameron F, McCormack PL. Obinutuzumab: first global approval. Drugs. January 2014, 74 (1): 147–54. PMID 24338113. S2CID 40983655. doi:10.1007/s40265-013-0167-3.

nps.org.au

National Prescribing Service. Sitagliptin for Type 2 Diabetes. 2010-08 [2010-08-27]. （原始内容存档于2010-07-18）.

pharmtech.com

Schweitzer, Mark; et al. Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharmaceutical Technology. February 2010, 34 (2): 52–59 [2023-05-16]. （原始内容存档于2016-06-24）.

qbdworks.com

1st QBD Approval for Biologics: Gazyva Design Space. 2014-03-18 [2023-05-16]. （原始内容存档于2014-03-18）.

qualitydigest.com

Early, John. Quality by Design, Part 1. Quality Digest. 2013-02-14 [2023-05-16]. （原始内容存档于2021-04-13）.
Early, John. Quality by Design, Part 2. Quality Digest. 2013-02-19 [2023-05-16]. （原始内容存档于2021-04-13）.

sciencedirect.com

Development of a new predictive modelling technique to find with confidence equivalence zone and design space of chromatographic analytical methods^{[失效連結]}

semanticscholar.org

api.semanticscholar.org

Cameron F, McCormack PL. Obinutuzumab: first global approval. Drugs. January 2014, 74 (1): 147–54. PMID 24338113. S2CID 40983655. doi:10.1007/s40265-013-0167-3.

web.archive.org

Schweitzer, Mark; et al. Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharmaceutical Technology. February 2010, 34 (2): 52–59 [2023-05-16]. （原始内容存档于2016-06-24）.
Early, John. Quality by Design, Part 1. Quality Digest. 2013-02-14 [2023-05-16]. （原始内容存档于2021-04-13）.
Early, John. Quality by Design, Part 2. Quality Digest. 2013-02-19 [2023-05-16]. （原始内容存档于2021-04-13）.
Pharmaceutical Quality for the 21st Century: A Risk-Based Approach https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm128080.htm （页面存档备份，存于互联网档案馆）
Process Validation: General Principles and Practices (PDF). FDA Guidance. 2019-06-05 [2023-05-16]. （原始内容存档 (PDF)于2009-09-16）.
Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report Share Tweet Linkedin Email Print Department of Health and Human Services U.S. Food and Drug Administration. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report Share Tweet Linkedin Email Print. U.S. FDA. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report Share Tweet Linkedin Email Print Department of Health and Human Services U.S. Food and Drug Administration. [2023-05-17]. （原始内容存档于2023-05-17）.
FDA Approves New Treatment for Diabetes （页面存档备份，存于互联网档案馆） 2006-10-17.
National Prescribing Service. Sitagliptin for Type 2 Diabetes. 2010-08 [2010-08-27]. （原始内容存档于2010-07-18）.
1st QBD Approval for Biologics: Gazyva Design Space. 2014-03-18 [2023-05-16]. （原始内容存档于2014-03-18）.
Presentation: GlycArt Biotechnology AG From Inception to trade sale – and what happened after... by Dr. Joël Jean-Mairet. Brussels, 2011-03-31
PHARMACEUTICAL DEVELOPMENT Q8(R2) (PDF). [2023-05-16]. （原始内容存档 (PDF)于2011-05-16）.
QUALITY RISK MANAGEMENT Q9 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2011-05-16）.
PHARMACEUTICAL QUALITY SYSTEM Q10 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2011-05-15）.
DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2012-07-11）.
TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT Q12 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2019-06-06）.
ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products dated 14 November 2018 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2019-06-06）.
ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation dated 14 November 2018 (PDF). [2023-05-16]. （原始内容存档 (PDF)于2019-06-06）.
Department of Health and Human Services U.S. Food and Drug Administration. Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report. [2023-05-17]. （原始内容存档于2023-05-17）.