LC‐NMR
, a hyphenated system of liquid chromatography (
LC
) and nuclear magnetic resonance (
NMR
), is an efficient technique used in various fields such as metabolites analysis, drug impurity profiling, structure elucidation, identification of volatile oils, analysis of pesticides, and other natural products. The technique provides quantitative information on chemical compositions, including the structure and type of functional groups. The major drawback of
LC‐NMR
is its low sensitivity that can be overcome by using cryogenic probes and higher magnetic field strength.
In this article, the
LC‐NMR
instrumentation, modes of operation, and sample preparation are introduced. Applications, advancement in the field, and performance of
LC‐NMR
compared with other analytical techniques are also discussed.
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Inebilizumab-cdon (Uplizna™) was currently approved by the United States Food and Drug Administration (USFDA) for the treatment of NMOSD (neuromyelitis optica spectrum disorder).
It was developed by Viela Bio (Nasdaq: VIE) USA. Inebilizumab-cdon (formerly MEDI-551) is a humanized antibody, which induces CD19 + B cell depletion by increasing antibody-dependent cell cytotoxicity (ADCC) and cell phagocytosis (ADCP) of effector cells. Various clinical trials exhibit its safe and effective pharmacokinetic and pharmacodynamic profile. In June 2019, Viela Bio submitted Biologics License Application (BLA) to the FDA based on the findings obtained from the N-Momentum trial. This article summarizes the milestones in the development of Inebilizumab-cdon leading to approval for the treatment of advanced NMOSD.
Pegfilgrastim-apgf (nyvepria) was currently approved by FDA for the treatment of febrile neutropenia associated with non-myeloid malignancies receiving myelosuppressive anticancer drugs. It was developed by Pfizer, USA. It is a PEGylated leukocyte growth stimulating factor indicated to reduce the incidence of febrile neutropenia in patients receiving anticancer drugs. Nyvepria is biosimilar to pegfilgrastim, approved by FDA on June 10, 2020. It is the fourth FDA-approved drug for the treatment of infection exhibiting febrile neutropenia. This review abridges the indicators in the development of nyvepria foremost to approval for the treatment of febrile neutropenia (FN), a biosimilar regulatory framework and current updates on the clinical trials (CTs).
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