Medicinale equivalente (Italian Wikipedia)

Analysis of information sources in references of the Wikipedia article "Medicinale equivalente" in Italian language version.

refsWebsite

Global rank Italian rank

24nih.gov

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12doi.org

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6oadoi.org

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6archive.org

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3normattiva.it

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1fda.gov

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1europa.eu

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1web.archive.org

1^st place

1cptech.org

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1jci.org

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archive.org

DW. Light, RN. Warburton, Extraordinary claims require extraordinary evidence., in J Health Econ, vol. 24, n. 5, Sep 2005, pp. 1030-3; discussion 1034-53, DOI:10.1016/j.jhealeco.2005.07.001, PMID 16087260.
B. M Davit, P. E Nwakama, G. J Buehler, D. P Conner, S. H Haidar, D. T Patel, Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration, in Annals of Pharmacotherapy, vol. 43, n. 10, 2009, pp. 1583–1597, DOI:10.1345/aph.1M141. URL consultato il 22 novembre 2012.
P. Pechlivanoglou, WJ. van der Veen; JH. Bos; MJ. Postma, Analyzing generic and branded substitution patterns in the Netherlands using prescription data., in BMC Health Serv Res, vol. 11, 2011, pp. 89, DOI:10.1186/1472-6963-11-89, PMID 21524312.
DA. Mott, RR. Cline, Exploring generic drug use behavior: the role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution., in Med Care, vol. 40, n. 8, Aug 2002, pp. 662-74, DOI:10.1097/01.MLR.0000020926.85284.8E, PMID 12187180.
WH. Shrank, JN. Liberman; MA. Fischer; J. Avorn; E. Kilabuk; A. Chang; AS. Kesselheim; TA. Brennan; NK. Choudhry, The consequences of requesting dispense as written., in Am J Med, vol. 124, n. 4, Apr 2011, pp. 309-17, DOI:10.1016/j.amjmed.2010.11.020, PMID 21435421.
J. Kersnik, J. Peklar, Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies., in J Clin Pharm Ther, vol. 31, n. 6, Dec 2006, pp. 577-83, DOI:10.1111/j.1365-2710.2006.00776.x, PMID 17176362.

cptech.org

Joseph A. DiMasi, http://www.cptech.org/ip/health/econ/dimasi2003.pdf “The price of innovation: new estimates of drug development cost” (PDF), su cptech.org, Journal of Health Economics 22(2003). URL consultato il 24 novembre 2012.

doi.org

dx.doi.org

B. Waning, E. Diedrichsen; S. Moon, A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries., in J Int AIDS Soc, vol. 13, 2010, pp. 35, DOI:10.1186/1758-2652-13-35, PMID 20840741.
TL. Riggs, Research and development costs for drugs., in Lancet, vol. 363, n. 9404, Jan 2004, pp. 184, DOI:10.1016/S0140-6736(03)15370-6, PMID 14738789.
DW. Light, RN. Warburton, Extraordinary claims require extraordinary evidence., in J Health Econ, vol. 24, n. 5, Sep 2005, pp. 1030-3; discussion 1034-53, DOI:10.1016/j.jhealeco.2005.07.001, PMID 16087260.
Alfredo García-Arieta, John Gordon, Bioequivalence Requirements in the European Union: Critical Discussion, in The AAPS Journal, vol. 14, n. 4, 2012, pp. 738–748, DOI:10.1208/s12248-012-9382-1. URL consultato il 1º dicembre 2012.
B. M Davit, P. E Nwakama, G. J Buehler, D. P Conner, S. H Haidar, D. T Patel, Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration, in Annals of Pharmacotherapy, vol. 43, n. 10, 2009, pp. 1583–1597, DOI:10.1345/aph.1M141. URL consultato il 22 novembre 2012.
P. Pechlivanoglou, WJ. van der Veen; JH. Bos; MJ. Postma, Analyzing generic and branded substitution patterns in the Netherlands using prescription data., in BMC Health Serv Res, vol. 11, 2011, pp. 89, DOI:10.1186/1472-6963-11-89, PMID 21524312.
DA. Mott, RR. Cline, Exploring generic drug use behavior: the role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution., in Med Care, vol. 40, n. 8, Aug 2002, pp. 662-74, DOI:10.1097/01.MLR.0000020926.85284.8E, PMID 12187180.
J. Puig-Junoy, Impact of European pharmaceutical price regulation on generic price competition: a review., in Pharmacoeconomics, vol. 28, n. 8, 2010, pp. 649-63, DOI:10.2165/11535360-000000000-00000, PMID 20515079.
WH. Shrank, JN. Liberman; MA. Fischer; J. Avorn; E. Kilabuk; A. Chang; AS. Kesselheim; TA. Brennan; NK. Choudhry, The consequences of requesting dispense as written., in Am J Med, vol. 124, n. 4, Apr 2011, pp. 309-17, DOI:10.1016/j.amjmed.2010.11.020, PMID 21435421.
A. Simmenroth-Nayda, E. Hummers-Pradier; T. Ledig; R. Jansen; W. Niebling; LM. Bjerre; MM. Kochen; W. Himmel, [Prescription of generic drugs in general practice. Results of a survey of general practitioners]., in Med Klin (Munich), vol. 101, n. 9, Sep 2006, pp. 705-10, DOI:10.1007/s00063-006-1097-6, PMID 16977394.
J. Kersnik, J. Peklar, Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies., in J Clin Pharm Ther, vol. 31, n. 6, Dec 2006, pp. 577-83, DOI:10.1111/j.1365-2710.2006.00776.x, PMID 17176362.
P. Le Corre, [Bioequivalence and generics of index drugs with narrow therapeutic margins]., in Presse Med, vol. 39, n. 2, Feb 2010, pp. 169-76, DOI:10.1016/j.lpm.2009.09.017, PMID 19932591.

europa.eu

eur-lex.europa.eu

Reg. EC 31 marzo 2004, n. 726 in materia di "laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency". testo

fda.gov

accessdata.fda.gov

(EN) The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. CFR - Code of Federal Regulations Title 21, su accessdata.fda.gov.

jci.org

John P. Moore, https://www.jci.org/articles/view/23540, su jci.org, The Journal of clinical investigation, 1º novembre 2004. URL consultato il 24 novembre 2012.

nih.gov

ncbi.nlm.nih.gov

B. Waning, E. Diedrichsen; S. Moon, A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries., in J Int AIDS Soc, vol. 13, 2010, pp. 35, DOI:10.1186/1758-2652-13-35, PMID 20840741.
TL. Riggs, Research and development costs for drugs., in Lancet, vol. 363, n. 9404, Jan 2004, pp. 184, DOI:10.1016/S0140-6736(03)15370-6, PMID 14738789.
DW. Light, RN. Warburton, Extraordinary claims require extraordinary evidence., in J Health Econ, vol. 24, n. 5, Sep 2005, pp. 1030-3; discussion 1034-53, DOI:10.1016/j.jhealeco.2005.07.001, PMID 16087260.
D. Vetchý, K. Frýbortová; M. Rabisková; H. Danecková, [Bioequivalence studies of pharmaceutical preparations]., in Cas Lek Cesk, vol. 146, n. 5, 2007, pp. 431-3, PMID 17554963.
ML. Chen, V. Shah; R. Patnaik; W. Adams; A. Hussain; D. Conner; M. Mehta; H. Malinowski; J. Lazor; SM. Huang; D. Hare, Bioavailability and bioequivalence: an FDA regulatory overview., in Pharm Res, vol. 18, n. 12, Dec 2001, pp. 1645-50, PMID 11785681.
G. Borgheini, The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs., in Clin Ther, vol. 25, n. 6, Jun 2003, pp. 1578-92, PMID 12860486.
AG. Dupont, F. Heller, Generics and cost-effective prescribing in Belgium: does bioequivalence always translate in therapeutic equivalence?, in Acta Clin Belg, vol. 64, n. 5, pp. 406-14, PMID 19999388.
P. Pechlivanoglou, WJ. van der Veen; JH. Bos; MJ. Postma, Analyzing generic and branded substitution patterns in the Netherlands using prescription data., in BMC Health Serv Res, vol. 11, 2011, pp. 89, DOI:10.1186/1472-6963-11-89, PMID 21524312.
DA. Mott, RR. Cline, Exploring generic drug use behavior: the role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution., in Med Care, vol. 40, n. 8, Aug 2002, pp. 662-74, DOI:10.1097/01.MLR.0000020926.85284.8E, PMID 12187180.
A. Nissen, [The market of synonymous preparations in Denmark 1985-1990. A comparison of prices and quantities on the market]., in Ugeskr Laeger, vol. 153, n. 50, Dec 1991, pp. 3558-62, PMID 1776198.
FS. Vieira, P. Zucchi, [Price differences between generic and innovator medicines in Brazil]., in Rev Saude Publica, vol. 40, n. 3, Jun 2006, pp. 444-9, PMID 16810368.
J. Puig-Junoy, Impact of European pharmaceutical price regulation on generic price competition: a review., in Pharmacoeconomics, vol. 28, n. 8, 2010, pp. 649-63, DOI:10.2165/11535360-000000000-00000, PMID 20515079.
L. Bulfone, High prices for generics in Australia - more competition might help., in Aust Health Rev, vol. 33, n. 2, maggio 2009, pp. 200-14, PMID 19563309.
BA. Briesacher, SE. Andrade; H. Fouayzi; KA. Chan, Medication adherence and use of generic drug therapies., in Am J Manag Care, vol. 15, n. 7, Jul 2009, pp. 450-6, PMID 19589012.
WH. Shrank, JN. Liberman; MA. Fischer; J. Avorn; E. Kilabuk; A. Chang; AS. Kesselheim; TA. Brennan; NK. Choudhry, The consequences of requesting dispense as written., in Am J Med, vol. 124, n. 4, Apr 2011, pp. 309-17, DOI:10.1016/j.amjmed.2010.11.020, PMID 21435421.
ML. Andersen, K. Laursen; M. Schaumann; SL. Rubak; P. Olesgaard; J. Mainz; T. Lauritzen, [How do patients evaluate the newly introduced system of substituting prescriptions?]., in Ugeskr Laeger, vol. 162, n. 45, Nov 2000, pp. 6066-9, PMID 11107943.
A. Simmenroth-Nayda, E. Hummers-Pradier; T. Ledig; R. Jansen; W. Niebling; LM. Bjerre; MM. Kochen; W. Himmel, [Prescription of generic drugs in general practice. Results of a survey of general practitioners]., in Med Klin (Munich), vol. 101, n. 9, Sep 2006, pp. 705-10, DOI:10.1007/s00063-006-1097-6, PMID 16977394.
J. Kersnik, J. Peklar, Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies., in J Clin Pharm Ther, vol. 31, n. 6, Dec 2006, pp. 577-83, DOI:10.1111/j.1365-2710.2006.00776.x, PMID 17176362.
E. Hellier, M. Tucker; N. Kenny; A. Rowntree; J. Edworthy, Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-the-counter medicines by laypeople., in J Patient Saf, vol. 6, n. 3, Sep 2010, pp. 158-64, PMID 21491790.
J. Emery, A. McKenzie; C. Bulsara; D. Holman, Controversy over generic substitution., in BMJ, vol. 341, 2010, pp. c3570, PMID 20610498.
SL. Rubak, ML. Andersen; J. Mainz; P. Olesgaard; T. Lauritzen, [How do practitioners evaluate the newly introduced system of substituting prescriptions?]., in Ugeskr Laeger, vol. 162, n. 45, Nov 2000, pp. 6070-3, PMID 11107944.
SL. Rubak, ML. Andersen; J. Mainz; P. Olesgaard; K. Laursen; M. Schaumann; T. Lauritzen, How do pharmacists evaluate the newly introduced system of substituting prescriptions?, in Ugeskr Laeger, vol. 162, n. 45, Nov 2000, pp. 6074-7, PMID 11107945.
LG. Keith, JJ. Oleszczuk; CS. Stika; S. Stine, Generics: what's in a name?, in Int J Fertil Womens Med, vol. 43, n. 3, Giu 1998, pp. 139-49, PMID 9692536.
P. Le Corre, [Bioequivalence and generics of index drugs with narrow therapeutic margins]., in Presse Med, vol. 39, n. 2, Feb 2010, pp. 169-76, DOI:10.1016/j.lpm.2009.09.017, PMID 19932591.

normattiva.it

Decreto legislativo 24 marzo 2006, n. 219, articolo 10, in materia di "Attuazione della direttiva 2001/83/CE (e successive direttive di modifica) relativa ad un codice comunitario concernente i medicinali per uso umano, nonché della direttiva 2003/94/CE"
Legge 29 dicembre 1995, n. 549, articolo 3, in materia di "Misure di razionalizzazione della finanza pubblica"
Legge 26 luglio 2005, n. 149, in materia di "Conversione in legge, con modificazioni, del decreto-legge 27 maggio 2005, n. 87, recante disposizioni urgenti per il prezzo dei farmaci non rimborsabili dal Servizio sanitario nazionale"

oadoi.org

B. Waning, E. Diedrichsen; S. Moon, A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries., in J Int AIDS Soc, vol. 13, 2010, pp. 35, DOI:10.1186/1758-2652-13-35, PMID 20840741.
TL. Riggs, Research and development costs for drugs., in Lancet, vol. 363, n. 9404, Jan 2004, pp. 184, DOI:10.1016/S0140-6736(03)15370-6, PMID 14738789.
Alfredo García-Arieta, John Gordon, Bioequivalence Requirements in the European Union: Critical Discussion, in The AAPS Journal, vol. 14, n. 4, 2012, pp. 738–748, DOI:10.1208/s12248-012-9382-1. URL consultato il 1º dicembre 2012.
J. Puig-Junoy, Impact of European pharmaceutical price regulation on generic price competition: a review., in Pharmacoeconomics, vol. 28, n. 8, 2010, pp. 649-63, DOI:10.2165/11535360-000000000-00000, PMID 20515079.
A. Simmenroth-Nayda, E. Hummers-Pradier; T. Ledig; R. Jansen; W. Niebling; LM. Bjerre; MM. Kochen; W. Himmel, [Prescription of generic drugs in general practice. Results of a survey of general practitioners]., in Med Klin (Munich), vol. 101, n. 9, Sep 2006, pp. 705-10, DOI:10.1007/s00063-006-1097-6, PMID 16977394.
P. Le Corre, [Bioequivalence and generics of index drugs with narrow therapeutic margins]., in Presse Med, vol. 39, n. 2, Feb 2010, pp. 169-76, DOI:10.1016/j.lpm.2009.09.017, PMID 19932591.

web.archive.org

(EN) Two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, will be essentially the same. NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE (PDF), su ema.europa.eu. URL consultato il 22 novembre 2012 (archiviato dall'url originale il 12 giugno 2013).