生物等效性 (Chinese Wikipedia)

Analysis of information sources in references of the Wikipedia article "生物等效性" in Chinese language version.

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11web.archive.org

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7doi.org

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5nih.gov

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4fda.gov

447^th place

581^st place

2who.int

195^th place

179^th place

2europa.eu

68^th place

209^th place

1archive.org

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1worldcat.org

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12^th place

1magtechjournal.com

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1raps.org

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1peoplespharmacy.com

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1nbcnews.com

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538^th place

archive.org

Tracy TS. Modern pharmacology with clinical applications. Hagerstwon, MD: Lippincott Williams & Wilkins. 2004: 49. ISBN 0-7817-3762-1.

doi.org

Birkett DJ. Generics - equal or not?. Australian Prescriber. 1 August 2003, 26 (4): 85–87. doi:10.18773/austprescr.2003.063 .
Maurer, Hans H. Multi-analyte procedures for screening for and quantification of drugs in blood, plasma, or serum by liquid chromatography-single stage or tandem mass spectrometry (LC-MS or LC-MS/MS) relevant to clinical and forensic toxicology. Clinical Biochemistry (Elsevier BV). 2005, 38 (4): 310–318. ISSN 0009-9120. PMID 15766732. doi:10.1016/j.clinbiochem.2005.01.014.
苏华; 郭瑞臣. 仿制药一致性评价的背景、实施及结局. 中国医院药学杂志. 2022, 42 (14). doi:10.13286/j.1001-5213.2022.14.21.
Wei, Y; Zhu, J; Qiao, J; Zhang, D; Chen, Y; Suchecki, S. The Impact of the Consistency Evaluation Policy of Generic Drugs on R&D Investment Intensity of Pharmaceutical Companies-An Empirical Study Based on the Difference-in-Differences Model.. Frontiers in public health. 2022, 10: 902025. PMC 9218526 . PMID 35757628. doi:10.3389/fpubh.2022.902025.
Liu, Q; Huang, Z; Mao, Z. Has the consistency evaluation policy of generic drugs promoted the innovation quality of Chinese pharmaceutical manufacturing industry? An empirical study based on the difference-in-differences model.. Frontiers in public health. 2023, 11: 1265756. PMC 10722264 . PMID 38106910. doi:10.3389/fpubh.2023.1265756.
Midha KK, McKay G. Bioequivalence; its history, practice, and future. The AAPS Journal. December 2009, 11 (4): 664–70. PMC 2782076 . PMID 19806461. doi:10.1208/s12248-009-9142-z.
Bate R, Mathur A, Lever HM, Thakur D, Graedon J, Cooperman T, et al. Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA. Trends in Pharmacological Sciences. March 2016, 37 (3): 184–191. PMID 26687297. doi:10.1016/j.tips.2015.11.005.

europa.eu

ema.europa.eu

Committee for Medicinal Products for Human Use. Guideline on the Investigation of Bioequivalence (PDF). European Medicines Agency. 20 January 2010 [21 April 2011]. （原始内容存档 (PDF)于2018-06-14）.
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. European Medicines Agency. 2017-03-24 [2020-11-17]. （原始内容存档于2020-10-26）.

fda.gov

Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations (PDF). United States Food and Drug Administration. 2003 [2023-06-26]. （原始内容存档 (PDF)于2017-06-23）. Center for Drug Evaluation and Research (2003). "Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations" （页面存档备份，存于互联网档案馆） (PDF). United States Food and Drug Administration.
Review of therapeutic equivalence: generic bupropion XL 300 mg and Wellbutrin XL 300 mg. Food and Drug Administration. [19 April 2008]. （原始内容存档于6 June 2011）.
Budeprion XL 300 mg not therapeutically equivalent to Wellbutrin XL 300 mg (新闻稿). FDA. 3 October 2012 [23 March 2013]. （原始内容存档于2019-04-24）.
FDA Update. FDA. October 2013 [15 June 2015]. （原始内容存档于2019-04-24）.

magtechjournal.com

journal18.magtechjournal.com

苏华; 郭瑞臣. 仿制药一致性评价的背景、实施及结局. 中国医院药学杂志. 2022, 42 (14). doi:10.13286/j.1001-5213.2022.14.21.

nbcnews.com

Stenson J. Report questions generic antidepressant. NBC News. 12 October 2007 [13 October 2007]. （原始内容存档于2013-10-11）.

nih.gov

ncbi.nlm.nih.gov

Maurer, Hans H. Multi-analyte procedures for screening for and quantification of drugs in blood, plasma, or serum by liquid chromatography-single stage or tandem mass spectrometry (LC-MS or LC-MS/MS) relevant to clinical and forensic toxicology. Clinical Biochemistry (Elsevier BV). 2005, 38 (4): 310–318. ISSN 0009-9120. PMID 15766732. doi:10.1016/j.clinbiochem.2005.01.014.
Wei, Y; Zhu, J; Qiao, J; Zhang, D; Chen, Y; Suchecki, S. The Impact of the Consistency Evaluation Policy of Generic Drugs on R&D Investment Intensity of Pharmaceutical Companies-An Empirical Study Based on the Difference-in-Differences Model.. Frontiers in public health. 2022, 10: 902025. PMC 9218526 . PMID 35757628. doi:10.3389/fpubh.2022.902025.
Liu, Q; Huang, Z; Mao, Z. Has the consistency evaluation policy of generic drugs promoted the innovation quality of Chinese pharmaceutical manufacturing industry? An empirical study based on the difference-in-differences model.. Frontiers in public health. 2023, 11: 1265756. PMC 10722264 . PMID 38106910. doi:10.3389/fpubh.2023.1265756.
Midha KK, McKay G. Bioequivalence; its history, practice, and future. The AAPS Journal. December 2009, 11 (4): 664–70. PMC 2782076 . PMID 19806461. doi:10.1208/s12248-009-9142-z.
Bate R, Mathur A, Lever HM, Thakur D, Graedon J, Cooperman T, et al. Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA. Trends in Pharmacological Sciences. March 2016, 37 (3): 184–191. PMID 26687297. doi:10.1016/j.tips.2015.11.005.

peoplespharmacy.com

Generic drug equality questioned. [13 October 2007]. （原始内容存档于20 October 2012）.

raps.org

存档副本. [2023-06-26]. （原始内容存档于2023-06-26）.

web.archive.org

WHO Guidance for organizations performing in vivo bioequivalence studies. (PDF). WHO Technical Report Series No. 996, Annex 9 (报告) (World Health Organization). 2016 [2023-06-26]. （原始内容存档 (PDF)于2022-03-08）.
Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations (PDF). United States Food and Drug Administration. 2003 [2023-06-26]. （原始内容存档 (PDF)于2017-06-23）. Center for Drug Evaluation and Research (2003). "Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations" （页面存档备份，存于互联网档案馆） (PDF). United States Food and Drug Administration.
WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability WHO Technical Report Series, No. 1003, 2017, Annex 6 (PDF). [2023-06-26]. （原始内容存档 (PDF)于2022-03-31）.
Committee for Medicinal Products for Human Use. Guideline on the Investigation of Bioequivalence (PDF). European Medicines Agency. 20 January 2010 [21 April 2011]. （原始内容存档 (PDF)于2018-06-14）.
存档副本. [2023-06-26]. （原始内容存档于2023-06-26）.
Generic drug equality questioned. [13 October 2007]. （原始内容存档于20 October 2012）.
Stenson J. Report questions generic antidepressant. NBC News. 12 October 2007 [13 October 2007]. （原始内容存档于2013-10-11）.
Review of therapeutic equivalence: generic bupropion XL 300 mg and Wellbutrin XL 300 mg. Food and Drug Administration. [19 April 2008]. （原始内容存档于6 June 2011）.
Budeprion XL 300 mg not therapeutically equivalent to Wellbutrin XL 300 mg (新闻稿). FDA. 3 October 2012 [23 March 2013]. （原始内容存档于2019-04-24）.
FDA Update. FDA. October 2013 [15 June 2015]. （原始内容存档于2019-04-24）.
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. European Medicines Agency. 2017-03-24 [2020-11-17]. （原始内容存档于2020-10-26）.

who.int

WHO Guidance for organizations performing in vivo bioequivalence studies. (PDF). WHO Technical Report Series No. 996, Annex 9 (报告) (World Health Organization). 2016 [2023-06-26]. （原始内容存档 (PDF)于2022-03-08）.
WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability WHO Technical Report Series, No. 1003, 2017, Annex 6 (PDF). [2023-06-26]. （原始内容存档 (PDF)于2022-03-31）.

worldcat.org

Maurer, Hans H. Multi-analyte procedures for screening for and quantification of drugs in blood, plasma, or serum by liquid chromatography-single stage or tandem mass spectrometry (LC-MS or LC-MS/MS) relevant to clinical and forensic toxicology. Clinical Biochemistry (Elsevier BV). 2005, 38 (4): 310–318. ISSN 0009-9120. PMID 15766732. doi:10.1016/j.clinbiochem.2005.01.014.