4,893 research outputs found
Data for '106W, picosecond Yb-doped fiber MOPA system with a radially polarized output beam'
No full textThis is original data for the paper: 106W, picosecond Yb-doped fiber MOPA system with a radially polarized output beam, published in the journal Optics Letters by the authors Di Lin, Neda Baktash, Shaif-ul Alam and David J. Richardson.
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Dataset for 'High-average-power picosecond mid-infrared OP-GaAs OPO'
No full textThis dataset supports the publication: Qiang Fu, Lin Xu, Sijing Liang, Peter Shardlow, David Shepherd, Shaif-Ul Alam, David Richardson High-average-power picosecond mid-infrared OP-GaAs OPO. Optics Express
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Advancing Generic Drug Development: A Comprehensive Approach to Azacitidine Bioequivalence Studies
No full text<p>The successful development of generic drug products requires meticulous attention to pharmaceutical, bioequivalent, and therapeutic equivalence compared to the reference listed drug (RLD). This entails matching the generic product's active ingredient, dosage form, strength, and route of administration with no significant differences in absorption rates. Bioequivalence testing, utilizing methods such as in vivo or in vitro assessments, is a crucial aspect of this process.</p>
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<p>Regulated by 21 CFR 320.24, applicants are mandated to employ the most accurate and reproducible approaches for bioequivalence testing. The FDA aids this by offering guidance, including the "Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA)" (August 2021), assisting in methodology selection for generic drug development.</p>
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<p>To further support the generic pharmaceutical industry, the FDA releases product-specific guidances (PSGs) outlining expectations for developing generic drug products equivalent to specific RLDs. These PSGs are instrumental in facilitating drug product development, ANDA submission, and approval, thereby enhancing access to generic drugs.</p>
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<p>Under the Generic Drug User Fee Amendments Reauthorization of 2022 (GDUFA III), the FDA commits to issuing PSGs based on specific goals. These goals include issuing PSGs for complex products approved after October 1, 2022, and continuing PSG development for complex products approved before that date. The FDA also targets issuing PSGs for non-complex drug products with new chemical entities within two years of approval for 90 percent of such products.</p>
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<p>Beyond GDUFA III PSG goals, the FDA considers various factors when prioritizing PSG development, including industry and stakeholder interest, drug availability, and public health priorities. Continuous assessment of ongoing research ensures PSGs align with current scientific understanding.</p>
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<p>For sponsors and investigators involved in investigational studies supporting an ANDA, referencing the current RLD labeling, including safety information, is crucial during study design and conduct. This encompasses considerations for subject screening, inclusion/exclusion criteria, and clinical safety monitoring. The FDA underscores the importance of contemplating BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS sections of the RLD labeling in study planning.</p>
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<p>In conclusion, strict adherence to FDA guidance and PSGs is paramount to ensuring the quality, safety, and efficacy of generic drug products, contributing significantly to their availability in the market.</p>
<p>Azacitidine, a vital drug in the treatment of hematological malignancies, presents a significant opportunity for generic drug development. The U.S. Food and Drug Administration (FDA) provides detailed guidance on conducting bioequivalence studies to ensure the safety and efficacy of generic versions. In this article, we explore the comprehensive approach recommended for the bioequivalence study of Azacitidine tablets.</p>
Invaluable CTD and Mixed Layer Depth data in northern coast of the Bay of Bengal
No full textThese CTD (Conductivity, Temperature, and Depth) profiles were collected with the help of the Bangladesh Navy by allowing boarded on BNS Sangu under the research project "Evaluation of Satellite-Derived Ocean Chlorophyll-a in the EEZ of Bangladesh" funded by the University Grant Commission, Bangladesh. The datasets contain the CTD profiles which ultimately give the vertical distributions of highly precise ocean temperature (°C), salinity (PSU), density (kg m-3), with the corresponding depth levels. The salinity and density were derived from the conductivity sensor and the depth further estimated by the pressure sensor, where it was considered as 1 dbar pressure almost equal to 1 m depth (in the shallow water). Later on, the Mixed Layer Depth was calculated based on the density threshold criteria where the density difference of 0.2 kg per cubic meter was considered to get the Mixed Layer Depth. Then the binary files (.srd) from the CTD (CTD90M HYDRO-BIOS Apparatebau GmbH, Germany) were processed as comma-separated-values (.csv) files by the data processing software SST-SDA provided by Sea & Sun Technology GmbH, Germany. However, these datasets were for 12 stations. The stations' latitude and longitude are attached here in a text file named "Station_information.txt". Mixed Layer Depth values are included in the MLD.txt file
Invaluable CTD and Mixed Layer Depth data in northern coast of the Bay of Bengal
No full textThese CTD (Conductivity, Temperature, and Depth) profiles were collected by the help of the Bangladesh Navy by allowing boarded on BNS Sangu under the research project "Evaluation of Satellite-Derived Ocean Chlorophyll-a in the EEZ of Bangladesh" funded by the University Grant Commission, Bangladesh. The datasets contain the CTD profiles which ultimately give the vertical distributions of highly precise ocean temperature (°C), salinity (PSU), density (kg m-3), with the corresponding depth levels. The salinity and density were derived from the conductivity sensor and the depth further estimated by the pressure sensor, where it was considered as 1 dbar pressure almost equal to 1 m depth (in the shallow water). Later on, the Mixed Layer Depth was calculated based on the density threshold criteria where the density difference of 0.2 kg per cubic meter was considered to get the Mixed Layer Depth. Then the binary files (.srd) from the CTD (CTD90M HYDRO-BIOS Apparatebau GmbH, Germany) were processed as comma-separated-values (.csv) files by the data processing software SST-SDA provided by Sea & Sun Technology GmbH, Germany. However, these datasets were for 12 stations. The stations' latitude and longitude are attached here in a text file named "Station_information.txt". Mixed Layer Depth values are included in the MLD.txt file
Advanced fibre circuitry for all-optical signal processing
No full textThis thesis presents results of new types of fibre lasers and oscillators as well as a new all-fibre nonlinear modulator with nearly instantaneous response time. The development of a simple and stable, passively mode-locked source of picosecond pulses is described in chapter 2. Here the mode locking of the laser was obtained by using the combined effect of frequency-shifted feedback and a nonlinear amplifying loop mirror. The new cavity configuration allowed tuning of the laser continuously over 25 nm of the erbium gain bandwidth by using a bulk diffraction grating. The shortest reported pulse width (1.2 ps) from this type of laser has been demonstrated. A complete characterisation of the laser, including its mode locking build-up time, is presented. Cascaded nonlinearity in quadratic nonlinear materials is the basis in realising nonlinearity free optical amplifiers. Experimental results on cascaded nonlinearity in a periodically poled lithium niobate sample are presented in chapter 3. A nonlinear phase shift of more than 1.5p was obtained from only a 4 mm long sample due to its large effective nonlinear refractive index coefficient (~1 x 10-13 cm2/W). Experiments on the nonlinear phase shift compensation in an optical fibre and amplifier are presented in chapter 4. Phase shift compensation of more than 1.5p has been successfully demonstrated. Chapter 5 presents theoretical investigations on the modulation of optical signals using the stimulated Raman scattering (SRS) process in silica fibre. Numerical results reveal that to modulate signals in this scheme it is necessary to consider other competing nonlinear effects such as cascaded SRS, modulation instability etc. actively. Signal modulation as fast as 250 - 300 GHz can be realised using this intensity modulator. Chapter 6 describes the experimental results on the modulation of optical signal using SRS in optical fibre. With this Raman intensity modulator, bit-by-bit modulation of 10 Gbit/s simulated data stream has been demonstrated. An extinction ratio (modulation depth) of more than 15 dB was realised. The proposed intensity modulator can also be used as a time domain scalpel and can create a dark pulse in a bright background
100W fully-fiberised ytterbium doped master oscillator power amplifier incorporating adaptive pulse shaping
No full textWe report a pulsed, fully-fiberised, Yb-doped MOPA with a maximum average output power of 100W. Adaptive pulse shaping was incorporated to reduce the impact of nonlinearities, delivering 2mJ flat-topped pulses with 20kW peak power
Dataset for High beam quality, watt-level, widely tunable, mid-infrared OP-GaAs optical parametric oscillator
No full textData supporting the publications: Fu, Q., Xu, L., Liang, S., Shardlow, P., Shepherd, D., Alam, S-U., & Richardson, D. (Accepted/In press). High beam quality, watt-level, widely tunable, mid-infrared OP-GaAs optical parametric oscillator. Optics Letters. </span
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