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11 records – page 1 of 2.

[Biopharmaceutical characteristics of pediatric pressed paracetamol suppositories]

https://arctichealth.org/en/permalink/ahliterature42716
Source
Farm Zh. 1975 Mar-Apr;(2):81-3
Publication Type
Article

Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: innovators, biosimilars, and intended copies.

https://arctichealth.org/en/permalink/ahliterature264908
Source
Joint Bone Spine. 2014 Dec;81(6):471-7
Publication Type
Article
Date
Dec-2014
Author
Gilberto Castañeda-Hernández
Zoltan Szekanecz
Eduardo Mysler
Valderilio F Azevedo
Renato Guzman
Miguel Gutierrez
Wilfredo Rodríguez
Dmitry Karateev
Source
Joint Bone Spine. 2014 Dec;81(6):471-7
Date
Dec-2014
Language
English
Publication Type
Article
Keywords
Biopharmaceutics
Biosimilar Pharmaceuticals
Drugs, Generic
Europe
Humans
India
Latin America
Rheumatic Diseases - drug therapy
Russia
Abstract
A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and formulation. Regulatory authorities strive to ensure the absence of clinically meaningful differences between biosimilars and their reference drugs. However, small molecular differences may potentially affect pharmacodynamics (including affinity), pharmacokinetics, and immunogenicity. Intended copies are non-innovator biopharmaceutical products that, unlike biosimilars, do not have enough clinical evidence to demonstrate biosimilarity. For approval of a biosimilar, most countries require preclinical and clinical studies demonstrating comparability with the reference drug. The margin for determining equivalence or non-inferiority is determined on a case-by-case basis in each country, as there are no general criteria. The European Medicines Agency and US Food and Drug Administration have stringent regulatory processes to ensure comparability of biosimilars with their reference drugs. There are also post-marketing surveillance requirements to monitor safety. Only one biosimilar, CT-P13, has been approved for rheumatoid arthritis. However, in countries with less stringent regulation, intended copies are being commercialized and safety problems have been documented. Consequently, in such countries, there is an urgent need for appropriate regulatory processes to be established. Attempts to close the affordability gap of biopharmaceuticals should not open another gap between patients treated with an innovator drug and an intended copy.
PubMed ID
24956990 View in PubMed
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[Insulin specialities. A survey of insulin specialities registrated in Norway January 1, 1973]

https://arctichealth.org/en/permalink/ahliterature49053
Source
Tidsskr Nor Laegeforen. 1973 Aug 20;93(23):1618-9
Publication Type
Article
Date
Aug-20-1973

[Kinetics of dimedrol absorption in the presence of high-molecular pharmaceutic aids in the rat intestine]

https://arctichealth.org/en/permalink/ahliterature8865
Source
Farm Zh. 1977 Nov-Dec;(6):74-5
Publication Type
Article

Relative bioavailability of commercial ampicillin formulations in man.

https://arctichealth.org/en/permalink/ahliterature254180
Source
Can Med Assoc J. 1973 Nov 17;109(10):989-93
Publication Type
Article
Date
Nov-17-1973
Author
M. Mayersohn
L. Endrenyi
Source
Can Med Assoc J. 1973 Nov 17;109(10):989-93
Date
Nov-17-1973
Language
English
Publication Type
Article
Keywords
Administration, Oral
Adult
Ampicillin - administration & dosage - blood - metabolism
Analysis of Variance
Biological Assay
Biopharmaceutics
Canada
Drug Compounding
Female
Humans
Intestinal Absorption
Male
Time Factors
Abstract
The relative bioavailability of three commercial ampicillin products was examined in 12 human subjects using a crossover experimental design. Based upon the areas under the ampicillin plasma concentration-time curves after the oral administration of 250 mg. ampicillin and using an analysis of variance technique no statistically significant differences were found between the products examined. These findings are in contrast to those of a recent report and appear to be explained by formulation differences. These relatively minor differences in formulation reflect the importance of formulation variables in providing efficient drug therapy. The intrasubject variation associated with several of these products is quite marked and is consistent with the incomplete and erratic absorption of this antibiotic in man.
Notes
Cites: Curr Ther Res Clin Exp. 1968 Jun;10(6):292-3034969836
Cites: J Pharm Sci. 1968 Nov;57(11):1945-85725926
Cites: Antimicrob Agents Chemother (Bethesda). 1969;9:35-415396513
Cites: Med J Aust. 1971 Apr 3;1(14):74-65573126
Cites: Antimicrob Agents Chemother (Bethesda). 1970;10:442-545521366
Cites: J Pharm Sci. 1972 Aug;61(8):1340-15050398
Cites: Can Med Assoc J. 1972 Aug 5;107(3):203-95052904
Cites: Pharmacology. 1972;8(1):33-434644654
Cites: J Pharm Sci. 1973 Jan;62(1):69-764630199
Cites: J Pharm Pharmacol. 1972 Dec;24:Suppl:152P-1534144878
Cites: J Pharmacokinet Biopharm. 1973 Apr;1(2):89-984764427
Cites: Am J Med Sci. 1963 May;245:544-5514033373
PubMed ID
4758871 View in PubMed
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11 records – page 1 of 2.