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Review Article

Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms

Pages 2179-2189 | Accepted 12 Jun 2009, Published online: 14 Jul 2009

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Rattanachai Chanchai, Rungsrit Kanjanavanit, Krit Leemasawat, Anong Amarittakomol, Paleerat Topaiboon & Arintaya Phrommintikul. (2018) Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic. Journal of Drug Assessment 7:1, pages 8-13.
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Mario Del Tacca, Giuseppe Pasqualetti, Giovanni Gori, Pasquale Pepe, Antonello Di Paolo, Marianna Lastella, Ferdinando De Negri & Corrado Blandizzi. (2013) Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers. Therapeutics and Clinical Risk Management 9, pages 303-311.
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Dong-Jin Jang, Taeyong Sim & Euichaul Oh. (2013) Formulation and optimization of spray-dried amlodipine solid dispersion for enhanced oral absorption. Drug Development and Industrial Pharmacy 39:7, pages 1133-1141.
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Paul J Declerck & Steven Simoens. (2012) A European perspective on the market accessibility of biosimilars. Biosimilars 2, pages 33-40.
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Paul J. Declerck, Feyza Darendeliler, Miklós Góth, Stanislava Kolouskova, Ioana Micle, Cees Noordam, Valentina Peterkova, Natalia N. Volevodz, Jiřina Zapletalová & Michael B. Ranke. (2010) Biosimilars: controversies as illustrated by rhGH. Current Medical Research and Opinion 26:5, pages 1219-1229.
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André Cotia, Haliton Alves Oliveira Junior, Jessica Y. Matuoka & Ícaro Boszczowski. (2023) Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis. Antibiotics 12:5, pages 935.
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R. Gomathi, R. Ganesamoorthy, S. Madeswaran, R. Parameswari, G. Vinitha & C. Ramki. (2023) Synthesis and characterization of cyclohexylammonium hydrogen maleate hemihydrate single crystal and its anti-bacterial activities. Materials Today: Proceedings.
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Georges Hatem, Nare Navasardyan, Elsa Lahoud, Sanaa Awada, Rana Itani, Roula Ajrouche & Mathijs Goossens. (2022) Predictors of substitution to generic drugs and physicians’ perceived exclusivity of substitution: A cross sectional survey among physicians. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 19:1, pages 23-32.
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Kyung-Bok Son. (2022) Who initiates price competition when generic entrants are introduced into the South Korean pharmaceutical market?. Frontiers in Public Health 10.
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Gulam Mustafa, Md Ali Mujtaba, Sabna Kotta, Abdullah Habeeballah, Nabil A. Alhakamy, Hibah M. Aldawsari, Shahid Karim & Shadab Md. 2022. Regulatory Affairs in the Pharmaceutical Industry. Regulatory Affairs in the Pharmaceutical Industry 215 240 .
Jacinthe Leclerc, Claudia Blais, Louis Rochette, Denis Hamel, Line Guénette, Claudia Beaudoin & Paul Poirier. (2020) Public Health Outcomes May Differ After Switching from Brand-Name to Generic Angiotensin II Receptor Blockers. Drugs in R&D 20:2, pages 135-145.
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Maria Agudelo, Carlos A. Rodriguez, Andres F. Zuluaga & Omar Vesga. (2019) Nontherapeutic equivalence of a generic product of imipenem-cilastatin is caused more by chemical instability of the active pharmaceutical ingredient (imipenem) than by its substandard amount of cilastatin. PLOS ONE 14:2, pages e0211096.
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Hema Kapoor, Mohd. Aqil, Syed Sarim Imam, Yasmin Sultana & Asgar Ali. (2019) Formulation of amlodipine nano lipid carrier: Formulation design, physicochemical and transdermal absorption investigation. Journal of Drug Delivery Science and Technology 49, pages 209-218.
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L Pasina, SAM Urru & S Mandelli. (2016) Why do patients have doubts about generic drugs in Italy?. European Journal of Clinical Pharmacology.
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Yang Yu, Steven Teerenstra, Cees Neef, David Burger & Marc Maliepaard. (2016) A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials. British Journal of Clinical Pharmacology 81:4, pages 667-678.
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A. O’Leary, C. Usher, M. Lynch, M. Hall, L. Hemeryk, S. Spillane, P. Gallagher & M. Barry. (2015) Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland. BMC Research Notes 8:1.
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Aleksandra Drozdowska & Tomasz Hermanowski. (2015) Solution-driven approaches to generic substitution challenges - a survey among international experts. Fundamental & Clinical Pharmacology 29:6, pages 592-603.
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Nazila Yousefi, Gholamhossein Mehralian, Farzad Peiravian & Samaneh NourMohammadi. (2015) Consumers’ perception of generic substitution in Iran. International Journal of Clinical Pharmacy 37:3, pages 497-503.
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Daniele Piovani, Antonio Clavenna, Massimo Cartabia, Angela Bortolotti, Ida Fortino, Luca Merlino & Maurizio Bonati. (2015) Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation. Pharmacoepidemiology and Drug Safety 24:2, pages 121-128.
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Y Yu, S Teerenstra, F Vanmolkot, C Neef, D Burger & M Maliepaard. (2013) Interchangeability of Gabapentin Generic Formulations in the Netherlands: A Comparative Bioavailability Study. Clinical Pharmacology & Therapeutics 94:4, pages 519-524.
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Jette Rathe, Pia Larsen, Morten Andersen, Maja Paulsen, Dorte Jarbøl, Janus Thomsen & Jens Soendergaard. (2013) Associations between generic substitution and patients' attitudes, beliefs and experiences. European Journal of Clinical Pharmacology 69:10, pages 1827-1836.
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Rhonda M. Cooper-DeHoff & William J. Elliott. (2013) Generic Drugs for Hypertension: Are They Really Equivalent?. Current Hypertension Reports 15:4, pages 340-345.
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Marta Herranz, Susana Morales-Alcelay, Ma Teresa Corredera-Hernández, José María de la Torre-Alvarado, Antonio Blázquez-Pérez, Ma Luisa Suárez-Gea, Covadonga Álvarez & Alfredo García-Arieta. (2012) Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison. European Journal of Clinical Pharmacology 69:5, pages 1157-1162.
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Hans C Ebbers, Stacy A Crow, Arnold G Vulto & Huub Schellekens. (2012) Interchangeability, immunogenicity and biosimilars. Nature Biotechnology 30:12, pages 1186-1190.
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G. W.'t Jong. (2012) In Vivo Inferiority of Generic Product Compared With Branded Vancomycin: A Paradigm Shift. Therapeutic Drug Monitoring 34:1, pages 2-3.
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Hans C. Ebbers, Toine Pieters, Hubert G. Leufkens & Huub Schellekens. (2012) Effective pharmaceutical regulation needs alignment with doctors. Drug Discovery Today 17:3-4, pages 100-103.
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Hee Youn ChoiJae Woo KimHyeong-Seok LimSang-Heon ChoJong-Lyul GhimSangmin ChoeJin Ah JungJonglae LimKyun-Seop Bae. (2012) Comparison of Pharmacokinetic Characteristics and the Safety between Amlodipine Maleate Tablet 5 mg and Amlodipine Besylate Tablet 5 mg. Journal of Korean Society for Clinical Pharmacology and Therapeutics 20:1, pages 42.
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Atholl Johnston, Roland Asmar, Björn Dahlöf, Kate Hill, David Albert Jones, Jens Jordan, Michael Livingston, Graham MacGregor, Michael Sobanja, Panagiotis Stafylas, Enrico Agabiti Rosei & José Zamorano. (2011) Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe. British Journal of Clinical Pharmacology 72:5, pages 727-730.
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Michael A Veronin. (2011) Should we have concerns with generic versus brand antimicrobial drugs? A review of issues. Journal of Pharmaceutical Health Services Research 2:3, pages 135-150.
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Antoni Sicras Mainar & Ruth Navarro Artieda. (2010) Influencia de la sustitución de medicamentos de marca por genéricos en el cumplimiento terapéutico de la hipertensión arterial y la dislipidemia. Gaceta Sanitaria 24:6, pages 473-482.
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