Results 21 to 30 of about 513,714 (276)

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

open access: yesAnnals of the New York Academy of Sciences, 2021
The diverse nature of complex drug products poses challenges for the development of regulatory guidelines for generic versions. While complexity is not new in medicines, the technical capacity to measure and analyze data has increased.
Kevin Klein   +5 more
semanticscholar   +1 more source

Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs.

open access: yesBlood Advances, 2021
Since the introduction of imatinib, the management of chronic myeloid leukemia (CML) has changed considerably. Tyrosine kinase inhibitors (TKIs) are the mainstay of CML treatment; however, the high financial burden of TKIs can be problematic for both the
Abdulkadir Erçalışkan   +2 more
semanticscholar   +1 more source

Evaluating the bioequivalence of levetiracetam brand and generic oral tablets available in the Saudi market in vivo

open access: yesSaudi Pharmaceutical Journal, 2023
Background: Epilepsy is a common global neurological disorder. About 30% of epileptic patients are managed with anti-epileptic Drugs (AEDs). Since 2000, Levetiracetam (LEV) has been marketed around the world as an AED under the brand name Keppra, and ...
Danah ALRabeeah   +3 more
doaj   +1 more source

Research and Education Needs for Complex Generics

open access: yesPharmaceutical Research, 2021
Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics ...
Sydney Stern   +9 more
semanticscholar   +1 more source

Language Signaling High Proportions and Generics Lead to Generalizing, but Not Essentializing, for Novel Social Kinds

open access: yesCognitive Sciences, 2021
Generics (e.g., "Dogs bark") are thought by many to lead to essentializing: to assuming that members of the same category share an internal property that causally grounds shared behaviors and traits, even without evidence of such a shared property ...
E. Hoicka   +4 more
semanticscholar   +1 more source

Availability of different branded generic vildagliptin after off-patenting: An observation from India

open access: yesJournal of Diabetology, 2023
Background: Branded generics offer comparable therapeutic benefits at a lower cost, making them essential in healthcare systems worldwide. Vildagliptin, a widely prescribed antidiabetic medication, is available in various branded generic forms.
Shambo S Samajdar   +5 more
doaj   +1 more source

Generics and the metaphysics of kinds

open access: yesPhilosophy Compass, 2021
Recent years have seen renewed interest in the semantics of generics. And a relatively mainstream view in this work is that the semantics of generics must appeal to kinds. But what are kinds?
David Liebesman, R. Sterken
semanticscholar   +1 more source

Beyond Generics [PDF]

open access: yesMAB, 2002
Op 25 oktober 2001 heeft Roland Speklé zijn proefschrift verdedigd aan de Erasmus Universiteit te Rotterdam. Het is een dun boekje geworden: afgezien van de literatuurlijst en een Nederlandse samenvatting, bevat het slechts 112 bladzijden.
Jan Van Helden
doaj   +3 more sources

Key problems of the foreign medicines contract production organization in developing countries

open access: yesRUDN Journal of Economics, 2023
Contract manufacturing is gaining momentum in the pharmaceutical industry. Many pharmaceutical companies that do not have enough time and financial resources to build a fullfledged drug development chain transfer some or all phases of development and ...
Sergey U. Chernikov   +2 more
doaj   +1 more source

Does the price matter? potency comparative study for different Ceftriaxone generics in the Egyptian market [PDF]

open access: yesERU Research Journal, 2023
There are a lot of ceftriaxone sodium generics in the Egyptian market with a huge variation in prices, this raises a tremendous question mark, does the difference in prices reflect a difference in potency?
Mohamed abdelaziz   +41 more
doaj   +1 more source

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