Results 81 to 90 of about 3,107,552 (340)

Switching patients from other inhaled corticosteroid devices to the Easyhaler(®) : historical, matched-cohort study of real-life asthma patients [PDF]

, 2014
Peer reviewedPublisher ...
Gould, Shuna, Hutton, Catherine, King, Christine, Price, David, Thomas, Vicky, von Ziegenweidt, Julie   +5 more
core   +1 more source

Structural insights into an engineered feruloyl esterase with improved MHET degrading properties

FEBS Letters, EarlyView.
A feruloyl esterase was engineered to mimic key features of MHETase, enhancing the degradation of PET oligomers. Structural and computational analysis reveal how a point mutation stabilizes the active site and reshapes the binding cleft, expading substrate scope.
Panagiota Karampa, Konstantinos Makryniotis, Theofani‐Iosifina Sousani, Evangelos Topakas, Vangelis Daskalakis, Maria Dimarogona   +5 more
wiley   +1 more source

In vitro and in vivo comparison of the anti-staphylococcal efficacy of generic products and the innovator of oxacillin

BMC Infectious Diseases, 2010
Background Oxacillin continues to be an important agent in the treatment of staphylococcal infections; many generic products are available and the only requirement for their approval is demonstration of pharmaceutical equivalence.
Agudelo Maria, Rodriguez Carlos A, Zuluaga Andres F, Vesga Omar   +3 more
doaj   +1 more source

Bioequivalence and therapeutic equivalence of psychotropic drugs

Postępy Psychiatrii i Neurologii, 2015
Introduction to the market of generic drugs has increased access to modern therapies and enabled significant reduction of their cost, leading to containment of public expenditures on drug reimbursement. The assessment of bioequivalence of reference and generic drugs is based on the assumption that two different drug products are equivalent when their ...
K. Rokita, E. Balkowiec-Iskra, G. Cessak
openaire   +1 more source

A methionine‐lined active site governs carbocation stabilization and product specificity in a bacterial terpene synthase

FEBS Letters, EarlyView.
This study reveals a unique active site enriched in methionine residues and demonstrates that these residues play a critical role by stabilizing carbocation intermediates through novel sulfur–cation interactions. Structure‐guided mutagenesis further revealed variants with significantly altered product profiles, enhancing pseudopterosin formation. These
Marion Ringel, Carl P. O. Helmer, Shani Zev, Ronja Driller, Emily Buhr, Markus Reinbold, Renana Schwartz, Gabriel Foley, Mikael Boden, Daniel Garbe, Gerhard Schenk, Dan Thomas Major, Bernhard Loll, Thomas Brück   +13 more
wiley   +1 more source

A new multivariate similarity factor for in vitro therapeutic equivalence assessment

, 2014
Pharmaceutical equivalence is an important issue in the regulatory approval of generic and similar drug products, particularly for those that will not be tested for bioequivalence.
Augusto Lyrio Traple Marcus, Takao Okamoto Rogrio, Noriko Yamamoto Rosa, D. Terezinha, Rebello Loureno Felipe   +4 more
semanticscholar   +1 more source

Valosin‐containing protein counteracts ATP‐driven dissolution of FUS condensates through its ATPase activity in vitro

FEBS Letters, EarlyView.
Biomolecular condensates formed by fused in sarcoma (FUS) are dissolved by high ATP concentrations yet persist in cells. Using a reconstituted system, we demonstrate that valosin‐containing protein (VCP), an AAA+ ATPase, counteracts ATP‐driven dissolution of FUS condensates through its D2 ATPase activity.
Hitomi Kimura, Shin‐ichi Tate, Kyota Yasuda   +2 more
wiley   +1 more source

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]

, 2018
Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa, Castaneda-Hernandez, CBER, CBER, CBER, CBER, CBER, CBER, CBER, CDSCO, CFDA, Christl, Cofepris, Gautam, Lozda, MCC, Minghetti, Olech, Priori, Rushvi, Schiestl   +20 more
core   +5 more sources

Linking neurogenesis, oligodendrogenesis, and myelination defects to neurodevelopmental disruption in primary mitochondrial disorders

FEBS Letters, EarlyView.
Mitochondrial remodeling shapes neural and glial lineage progression by matching metabolic supply with demand. Elevated OXPHOS supports differentiation and myelin formation, while myelin compaction lowers mitochondrial dependence, revealing mitochondria as key drivers of developmental energy adaptation.
Sahitya Ranjan Biswas, Porter L. Tomsick, Alicia M. Pickrell, Paul D. Morton   +3 more
wiley   +1 more source

Generic therapy: the problem of choice

Кардиоваскулярная терапия и профилактика, 2009
The main differences between original and generic medications are discussed, and the criteria necessary for official generic registration are presented.
S. N. Tolpygina
doaj