-
1
-
-
84872371625
-
-
FDA. Guidance on bioavailability and bioequivalence studies for orally administrated drug products - general considerations. Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD,
-
FDA. Guidance on bioavailability and bioequivalence studies for orally administrated drug products - general considerations. Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, 2003. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
-
(2003)
-
-
-
2
-
-
84872384435
-
-
Health Canada. Guidance document: conduct and analysis of comparative bioavailability studies. Health Canada, Ottawa, ON,
-
Health Canada. Guidance document: conduct and analysis of comparative bioavailability studies. Health Canada, Ottawa, ON, 2002. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd_cbs_ebc_ld-eng.pdf.
-
(2002)
-
-
-
3
-
-
84872385765
-
-
European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. Committee for Medicinal Products for Human Use, London, January 20,
-
European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. Committee for Medicinal Products for Human Use, London, January 20, 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
-
(2010)
-
-
-
4
-
-
84872387851
-
Quantitative evaluation of bioequivalence/biosimilarity
-
doi:10.4172/jbb.S1-002.
-
Chow S-C.Quantitative evaluation of bioequivalence/biosimilarity. Journal of Bioequivalence and Bioavailability 2011; S1. doi:10.4172/jbb.S1-002.
-
(2011)
Journal of Bioequivalence and Bioavailability
, vol.1 S
-
-
Chow, S.-C.1
-
5
-
-
80052264051
-
Biosimilars: an overview
-
Sekhon BS.Biosimilars: an overview. Biosimilars 2011; 1:1-11.
-
(2011)
Biosimilars
, vol.1
, pp. 1-11
-
-
Sekhon, B.S.1
-
6
-
-
84872411560
-
-
FDA. Draft guidance for industry - scientific considerations in demonstrating biosimilarity to a reference product. Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, February
-
FDA. Draft guidance for industry - scientific considerations in demonstrating biosimilarity to a reference product. Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, February 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf.
-
(2012)
-
-
-
7
-
-
84872373874
-
-
European Medicines Agency (EMEA). Guideline on similar medicinal biological products. Committee for Medicinal Products for Human Use, London, October 30,
-
European Medicines Agency (EMEA). Guideline on similar medicinal biological products. Committee for Medicinal Products for Human Use, London, October 30, 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf.
-
(2005)
-
-
-
8
-
-
84872373151
-
-
Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs). Health Products and Food Branch, Ottawa, ON, March 5,
-
Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs). Health Products and Food Branch, Ottawa, ON, March 5, 2010. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf.
-
(2010)
-
-
-
9
-
-
84872382780
-
-
WHO. Guidelines on evaluation of similar biotherapeutic products (SBPs). World Health Organization, Geneva, October 19-23,
-
WHO. Guidelines on evaluation of similar biotherapeutic products (SBPs). World Health Organization, Geneva, October 19-23, 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.
-
(2009)
-
-
-
10
-
-
84872423569
-
-
Nightingale SL (FDA Assoc. Commissioner). Therapeutic equivalence of generic drugs - letter to health practitioners, January 28,
-
Nightingale SL (FDA Assoc. Commissioner). Therapeutic equivalence of generic drugs - letter to health practitioners, January 28, 1998. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm.
-
(1998)
-
-
-
13
-
-
0027244039
-
On population and individual bioequivalence
-
Schall R, Luus HG.On population and individual bioequivalence. Statistics in Medicine 1993; 12:1109-1124.
-
(1993)
Statistics in Medicine
, vol.12
, pp. 1109-1124
-
-
Schall, R.1
Luus, H.G.2
-
14
-
-
0026481178
-
Bioequivalence revisited
-
Sheiner LB.Bioequivalence revisited. Statistics in Medicine 1992; 11:1777-1788.
-
(1992)
Statistics in Medicine
, vol.11
, pp. 1777-1788
-
-
Sheiner, L.B.1
-
15
-
-
84872372215
-
-
FDA. Guidance for industry - statistical approaches to establishing bioequivalence. Center for Drug Evaluation and Research, US Food and Drug Administration:Rockville, MD, January
-
FDA. Guidance for industry - statistical approaches to establishing bioequivalence. Center for Drug Evaluation and Research, US Food and Drug Administration:Rockville, MD, January 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf.
-
(2001)
-
-
-
16
-
-
0030949859
-
Individual bioequivalence - a regulatory update (with discussion)
-
Chen M-L.Individual bioequivalence - a regulatory update (with discussion). Journal of Biopharmaceutical Statistics 1997; 7:105-111.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 105-111
-
-
Chen, M.-L.1
-
17
-
-
0030464885
-
Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence
-
Hauck WW, Chen M-L, Hyslop T, Patnaik R, Schuirmann D, Williams RL.Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. International Journal of Clinical Pharmacology and Therapeutics 1996; 34:535-541.
-
(1996)
International Journal of Clinical Pharmacology and Therapeutics
, vol.34
, pp. 535-541
-
-
Hauck, W.W.1
Chen, M.-L.2
Hyslop, T.3
Patnaik, R.4
Schuirmann, D.5
Williams, R.L.6
-
18
-
-
0031857671
-
Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence
-
Endrenyi L, Hao Y.Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence. International Journal of Clinical Pharmacology and Therapeutics 1998; 36:450-457.
-
(1998)
International Journal of Clinical Pharmacology and Therapeutics
, vol.36
, pp. 450-457
-
-
Endrenyi, L.1
Hao, Y.2
-
19
-
-
0034735583
-
Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence
-
Endrenyi L, Taback N, Tothfalusi L.Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence. Statistics in Medicine 2000; 19:2867-2878.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2867-2878
-
-
Endrenyi, L.1
Taback, N.2
Tothfalusi, L.3
-
20
-
-
0034735561
-
A small sample confidence interval approach to assess individual bioequivalence
-
Hyslop T, Hsuan F, Holder DJ.A small sample confidence interval approach to assess individual bioequivalence. Statistics in Medicine 1997; 19:2885-2897.
-
(1997)
Statistics in Medicine
, vol.19
, pp. 2885-2897
-
-
Hyslop, T.1
Hsuan, F.2
Holder, D.J.3
-
21
-
-
0033038778
-
Individual bioequivalence - a review of the FDA draft guidance
-
Chow S-C.Individual bioequivalence - a review of the FDA draft guidance. Drug Information Journal 1999; 33:435-444.
-
(1999)
Drug Information Journal
, vol.33
, pp. 435-444
-
-
Chow, S.-C.1
-
22
-
-
0031721971
-
Individual bioequivalence: attractive in principle, difficult in practice
-
Endrenyi L, Amidon GL, Midha KK, Skelly JP.Individual bioequivalence: attractive in principle, difficult in practice. Pharmaceutical Research 1998; 15:1321-1325.
-
(1998)
Pharmaceutical Research
, vol.15
, pp. 1321-1325
-
-
Endrenyi, L.1
Amidon, G.L.2
Midha, K.K.3
Skelly, J.P.4
-
23
-
-
84872366946
-
-
BPCI Act. Biologics Price Competition and Innovation Act of 2009. Federal Register. 2010; H.R. 3590-686-702.
-
BPCI Act. Biologics Price Competition and Innovation Act of 2009. Federal Register. 2010; H.R. 3590-686-702. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf.
-
-
-
-
24
-
-
84872414107
-
-
FDA. Draft guidance for industry - quality considerations in demonstrating biosimilarity to a reference protein product. Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, February
-
FDA. Draft guidance for industry - quality considerations in demonstrating biosimilarity to a reference protein product. Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, February 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf.
-
(2012)
-
-
-
25
-
-
84872375313
-
-
FDA. Draft guidance for industry - biosimilars: questions and answers regarding implementation of the Price Competition and Implementation Act of 2009. Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, February
-
FDA. Draft guidance for industry - biosimilars: questions and answers regarding implementation of the Price Competition and Implementation Act of 2009. Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, February 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm273001.pdf.
-
(2012)
-
-
-
26
-
-
84872394051
-
-
European Medicines Agency (EMA). Concept paper on the revision of the guideline of similar biological medicinal product. Committee for Medicinal Products for Human Use, London, November 17,
-
European Medicines Agency (EMA). Concept paper on the revision of the guideline of similar biological medicinal product. Committee for Medicinal Products for Human Use, London, November 17, 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500117987.pdf.
-
(2011)
-
-
-
27
-
-
84872369265
-
-
European Medicines Agency (EMA). Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Committee for Medicinal Products for Human Use, London, September 22,
-
European Medicines Agency (EMA). Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Committee for Medicinal Products for Human Use, London, September 22, 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/10/WC500115611.pdf.
-
(2011)
-
-
-
28
-
-
84872383085
-
-
European Medicines Agency (EMEA). Guideline on similar medicinal biological products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Committee for Medicinal Products for Human Use, London, February 22,
-
European Medicines Agency (EMEA). Guideline on similar medicinal biological products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Committee for Medicinal Products for Human Use, London, February 22, 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf.
-
(2006)
-
-
-
29
-
-
84860285348
-
On the regulatory approval pathway of biosimilar products
-
Wang J, Chow S-C.On the regulatory approval pathway of biosimilar products. Pharmaceuticals 2012; 5(4):353-368.
-
(2012)
Pharmaceuticals
, vol.5
, Issue.4
, pp. 353-368
-
-
Wang, J.1
Chow, S.-C.2
|