scholarly journals Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities

2021 ◽  
Vol 14 (4) ◽  
pp. 306
Author(s):  
Beverly Ingram ◽  
Rebecca S. Lumsden ◽  
Adriana Radosavljevic ◽  
Christine Kobryn
Keyword(s):  
Regulatory Science ◽  
European Medicines Agency ◽  
Specific Data ◽  
Safety And Efficacy ◽  
Regulatory Authorities ◽  
Comparative Safety ◽  
Health Canada ◽  
Insight Into ◽  
Distinct Distribution

Slow uptake of biosimilars in some regions is often attributed to a lack of knowledge combined with concerns about safety and efficacy. To alleviate physician and patient apprehensions, regulatory reviews from four major regulatory authorities (RAs) (European Medicines Agency, US Food and Drug Administration, Health Canada, and Japan Pharmaceuticals and Medical Devices Authority) across a portfolio of eight biosimilars were analyzed to provide insight into RA review focus and approach. RA queries were evaluated in an unbiased and systematic manner by major classification (Chemistry, Manufacturing and Controls [CMC], nonclinical, clinical or regulatory) and then via detailed sub-classification. There was a consistent, predominant focus on CMC from all RAs. The review focus based on sub-classification of clinical and regulatory queries was influenced by molecular complexity, with significant differences between categories (monoclonal antibody or protein) in the distribution of query topics; specifically, bioanalytical (p = 0.023), comparative safety and efficacy (p = 0.023), and statutory (including the justification of extrapolation) (p = 0.00033). Each biosimilar had a distinct distribution of clinical query topics, tailored to product-specific data. This analysis elucidated areas of heightened RA interest, and validated their application of regulatory science in the evaluation of biosimilar safety and efficacy.

Classification of Infant Vocalizations by Untrained Listeners

2019 ◽  
Vol 62 (9) ◽  
pp. 3265-3275
Author(s):  
Heather L. Ramsdell-Hudock ◽  
Anne S. Warlaumont ◽  
Lindsey E. Foss ◽  
Candice Perry
Keyword(s):  
Formal Education ◽  
Additional Insight ◽  
Listener Responses ◽  
Infant Vocalization ◽  
Early Infant ◽  
Infant Vocalizations ◽  
Audio Recordings ◽  
Speech And Language Development ◽  
Insight Into

Purpose To better enable communication among researchers, clinicians, and caregivers, we aimed to assess how untrained listeners classify early infant vocalization types in comparison to terms currently used by researchers and clinicians. Method Listeners were caregivers with no prior formal education in speech and language development. A 1st group of listeners reported on clinician/researcher-classified vowel, squeal, growl, raspberry, whisper, laugh, and cry vocalizations obtained from archived video/audio recordings of 10 infants from 4 through 12 months of age. A list of commonly used terms was generated based on listener responses and the standard research terminology. A 2nd group of listeners was presented with the same vocalizations and asked to select terms from the list that they thought best described the sounds. Results Classifications of the vocalizations by listeners largely overlapped with published categorical descriptors and yielded additional insight into alternate terms commonly used. The biggest discrepancies were found for the vowel category. Conclusion Prior research has shown that caregivers are accurate in identifying canonical babbling, a major prelinguistic vocalization milestone occurring at about 6–7 months of age. This indicates that caregivers are also well attuned to even earlier emerging vocalization types. This supports the value of continuing basic and clinical research on the vocal types infants produce in the 1st months of life and on their potential diagnostic utility, and may also help improve communication between speech-language pathologists and families.

scholarly journals Ecotoxicological Assessment of Microplastics in Freshwater Sources—A Review

Water ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 56
Author(s):  
Martina Miloloža ◽  
Dajana Kučić Grgić ◽  
Tomislav Bolanča ◽  
Šime Ukić ◽  
Matija Cvetnić ◽  
...  
Keyword(s):  
Complex Problem ◽  
Living Standards ◽  
Way Of Life ◽  
Inorganic Pollutants ◽  
Ecotoxicological Assessment ◽  
Characterization Methods ◽  
Special Concern ◽  
Micro Organisms ◽  
Insight Into

High living standards and a comfortable modern way of life are related to an increased usage of various plastic products, yielding eventually the generation of an increased amount of plastic debris in the environment. A special concern is on microplastics (MPs), recently classified as contaminants of emerging concern (CECs). This review focuses on MPs’ adverse effects on the environment based on their bioactivity. Hence, the main topic covered is MPs’ ecotoxicity on various aquatic (micro)organisms such as bacteria, algae, daphnids, and fish. The cumulative toxic effects caused by MPs and adsorbed organic/inorganic pollutants are presented and critically discussed. Since MPs’ bioactivity, including ecotoxicity, is strongly influenced by their properties (e.g., types, size, shapes), the most common classification of MPs types present in freshwater are provided, along with their main characteristics. The review includes also the sources of MPs discharge in the environment and the currently available characterization methods for monitoring MPs, including identification and quantification, to obtain a broader insight into the complex problem caused by the presence of MPs in the environment.

scholarly journals Geometrically rational real conic bundles and very transitive actions

2010 ◽  
Vol 147 (1) ◽  
pp. 161-187 ◽  
Author(s):  
Jérémy Blanc ◽  
Frédéric Mangolte
Keyword(s):  
Automorphism Groups ◽  
Algebraic Surfaces ◽  
Algebraic Models ◽  
Transitive Automorphism ◽  
Real Locus ◽  
Real Algebraic Surfaces ◽  
Conic Bundles ◽  
Transitive Actions ◽  
Insight Into

AbstractIn this article we study the transitivity of the group of automorphisms of real algebraic surfaces. We characterize real algebraic surfaces with very transitive automorphism groups. We give applications to the classification of real algebraic models of compact surfaces: these applications yield new insight into the geometry of the real locus, proving several surprising facts on this geometry. This geometry can be thought of as a half-way point between the biregular and birational geometries.

scholarly journals Characterizing block-copolymer micelles used in nanomedicines via solution static scattering techniques

2021 ◽  
Author(s):  
Isamu Akiba ◽  
Kazuo Sakurai
Keyword(s):  
Block Copolymer ◽  
Block Copolymers ◽  
Static Solution ◽  
Theoretical Background ◽  
Hydrophobic Drugs ◽  
Safety And Efficacy ◽  
Critical Quality Attributes ◽  
Regulatory Authorities ◽  
Block Copolymer Micelles ◽  
Copolymer Micelles

AbstractBlock copolymers are well recognized as excellent nanotools for delivering hydrophobic drugs. The formulation of such delivery nanoparticles requires robust characterization and clarification of the critical quality attributes correlating with the safety and efficacy of the drug before applying to regulatory authorities for approval. Static solution scattering from block copolymers is one such technique. This paper first outlines the theoretical background and current models for analyzing this scattering and then presents an overview of our recent studies on block copolymers.

Reader response: Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion

Neurology ◽  
2018 ◽  
Vol 91 (24) ◽  
pp. 1114.2-1115
Author(s):  
Aravind Ganesh ◽  
Bijoy K. Menon ◽  
Mayank Goyal ◽  
Andrew M. Demchuk ◽  
Michael D. Hill
Keyword(s):  
Reader Response ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Vessel Occlusion ◽  
Safety And Efficacy ◽  
Comparative Safety

Permutation Min-Entropy and Statistical Complexity Analysis of Electricity Spot Price

2015 ◽  
Vol 14 (04) ◽  
pp. 1550040 ◽  
Author(s):  
Qingju Fan ◽  
Dan Li
Keyword(s):  
Temporal Dynamics ◽  
Complexity Analysis ◽  
Spot Price ◽  
Temporal Correlations ◽  
Price Series ◽  
Statistical Complexity ◽  
Electricity Spot Price ◽  
Insight Into ◽  
Refined Classification

In this study, we investigate the subtle temporal dynamics of California 1999–2000 spot price series based on permutation min-entropy (PME) and complexity-entropy causality plane. The dynamical transitions of price series are captured and the temporal correlations of price series are also discriminated by the recently introduced PME. Moreover, utilizing the CECP, we provide a refined classification of the monthly price dynamics and obtain an insight into the stochastic nature of price series. The results uncover that the spot price signal presents diverse temporal correlations and exhibits a higher stochastic behavior during the periods of crisis.

Author response: Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion

Neurology ◽  
2018 ◽  
Vol 91 (24) ◽  
pp. 1116-1116
Author(s):  
Nitin Goyal ◽  
Georgios Tsivgoulis ◽  
Andrei V. Alexandrov ◽  
Adam S. Arthur
Keyword(s):  
Large Vessel ◽  
Author Response ◽  
Large Vessel Occlusion ◽  
Vessel Occlusion ◽  
Safety And Efficacy ◽  
Comparative Safety

scholarly journals تخصيص العام بالأدلة المنفصلة " دراسـة تطبيقية "

2018 ◽  
Vol 14 (1) ◽  
pp. 30-64
Author(s):  
الهادي جار النبي أحمد
Keyword(s):  
Applied Study ◽  
The One ◽  
Insight Into

The study entitled specifying prevalent utterance by separate evidence as applied study upon disagreement of fundamentalists in specifying prevalent utterance by separate evidence which might appear to be an obvious problem for the one who made aware of this disagreement particularly if he is not one of the specialists in jurisprudence. Accordingly, the main objective of this research is to identify this disagreement and to have by then insight into it through induction, analysis, and classification to find out whether it is influential disagreement when it runs into application on branches of jurisprudence or it is an only non-influential disagreement of utterance on the purpose of causing controversy along with overcoming in debate as in the case of much disagreements of fundamentalists. It is obviously that self-contained determinants in terms of numbers have been tackled so that a part of fundamentalists indicated them as nine in number, some others divided them into two sections, while others accounted them as four in number, namely mind, sense, text, and custom and by then considering remnants as branches affiliated to each other. In so far as the matter gets to this point, the researcher did not think that it should be indicated determinants as four in number and by then branches them out, but it was thought better to take trace of ancient fundamentalists in their classification. A number of results were reached by the study; some of the most important ones were: no consensus of opinion that achieved terms of being real consensus found relevant to these self-contained determinants, but all determinants have been tackled by disagreement despite the fact that some fundamentalists depicted the determinants as acquiescence in a part of their statements. Based on the results of the research, it was clearly found that it is a disagreement of utterance not disagreement of intangible content, as well as it has no influence on the classification of jurisprudence.

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