Results 191 to 200 of about 3,107,552 (340)

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

European Journal of Pharmaceutical Sciences, 2011
Mei-ling Chen, V. Shah, D. Crommelin, L. Shargel, Dennis Bashaw, M. Bhatti, H. Blume, J. Dressman, M. Ducharme, P. Fackler, T. Hyslop, Lorelei Lutter, J. Morais, E. Ormsby, Saji Thomas, Y. Tsang, R. Velagapudi, Lawrence X. Yu   +17 more
semanticscholar   +2 more sources

Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization. [PDF]

Front Med (Lausanne)
Niazi SK.
europepmc   +1 more source

Prognostic Implications of Sleep Architecture for Patients Admitted to the Intensive Care Unit With Status Epilepticus

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective Status epilepticus (SE) is associated with significant mortality. Sleep architecture may reflect normal brain function. Impaired sleep architecture is associated with poorer outcomes in numerous conditions. Here we investigate the association of sleep architecture in continuous EEG (cEEG) with survival in SE.
Ran R. Liu, Marcus C. Ng, Gavin P. Winston, Sabrina Schaly, Garima Shukla, Lysa Boissé Lomax   +5 more
wiley   +1 more source

Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration. [PDF]

BMJ Open Ophthalmol
Balser S, Capsius B, Hole R, Papp A, Preissinger N, Rozenknop A, Tiko T.   +6 more
europepmc   +1 more source

Developmental, Neuroanatomical and Cellular Expression of Genes Causing Dystonia

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective Dystonia is one of the most common movement disorders, with variants in multiple genes identified as causative. However, an understanding of which developmental stages, brain regions, and cell types are most relevant is crucial for developing relevant disease models and therapeutics.
Darren Cameron, Nicholas E. Clifton, Daniel Cabezas de la Fuente, Peter Holmans, Nicholas J. Bray, Kathryn J. Peall   +5 more
wiley   +1 more source

ALS With and Without Upper Motor Neuron Signs: A Comparative Study Supporting the Gold Coast Criteria

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective The Gold Coast criteria permit diagnosis of amyotrophic lateral sclerosis (ALS) even without upper motor neuron (UMN) signs. However, whether ALS patients with UMN signs (ALSwUMN) and those without (ALSwoUMN) share similar characteristics and prognoses remains unclear.
Hee‐Jae Jung, E‐nae Cheong, Jungmin So, Heung‐Won Kang, Yangsean Choi, Eun‐Jae Lee, Hyunjin Kim, Young‐Min Lim   +7 more
wiley   +1 more source

A Randomized Phase 1 Study Comparing the PK, PD, Safety, and Immunogenicity of Proposed Biosimilar RGB-14-X and Denosumab in Healthy Adult Males. [PDF]

Clin Transl Sci
Biver E, Body JJ, Sachdeva A, Študentová H, Nagy Z, Kun A, Horvát-Karajz K, Kiefer J, Pap T, Jókai E, Vasas FB, Seefried L.   +11 more
europepmc   +1 more source

Therapeutic Equivalence Requires Pharmaceutical, Pharmacokinetic, and Pharmacodynamic Identities: True Bioequivalence of a Generic Product of Intravenous Metronidazole

Antimicrobial Agents and Chemotherapy, 2012
Maria Agudelo, O. Vesga
semanticscholar   +1 more source

Predicting Loss of Ambulation in Limb Girdle Muscular Dystrophy R9

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Limb girdle muscular dystrophy type R9 (LGMDR9) results from biallelic variants in FKRP. There is limited data to predict loss of ambulation (LOA) among those with LGMDR9. Methods Participants in an ongoing dystroglycanopathy natural history study (NCT00313677) with FKRP variants who had achieved ambulation and were more than 3 ...
Chandra L. Miller, Lauren N. Coffey, Shelley R. H. Mockler, Katie M. Laubscher, Carrie M. Stephan, M. Bridget Zimmerman, Katherine D. Mathews   +6 more
wiley   +1 more source

Efficacy and safety of denosumab biosimilars in the treatment of postmenopausal osteoporosis: A systematic review of randomized clinical trials. [PDF]

Clin Exp Med
Shakibaei F, Malekshahi S, Heidari N, Heidari A.   +3 more
europepmc   +1 more source