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Candidate formulations must satisfy necessary and sufficient conditions.
Molecular building blocks are represented as points on the diagram, and the synthesis of candidate formulations is achieved by adding molecular fragments using linear mixing rules.
Structured databases, appropriate pure component as well as mixture property models, rule-based selection criteria and CAMD techniques are employed together to obtain one or more candidate formulations.
A combination experimental approach, utilizing semi-empirical excipient screening followed by statistical modeling using design of experiments (DOE), was undertaken to identify stabilizing candidate formulations for a lyophilized live attenuated Flavivirus vaccine candidate.
In addition to reducing the solution viscosities to acceptable levels for parenteral administration (using currently available and acceptable delivery devices), the candidate formulations did not result in notable losses of physicochemical stability of the 2 antibodies on storage for 6 months at 25°C.
The selection of final candidate formulations must therefore be based on a balance between improvement in immunogenicity and increase in reactogenicity.
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In product development, it is used to assist in the selection of a candidate formulation, in research to detect the influence of critical manufacturing variables, such as the binder effect, mixing effect, granulation procedure, coating parameters, and excipient type [ 1].
Yet, a combination of increased stability together with specific features of WIV which promote vaccine availability, like strong immunogenicity, dose sparing quality and manufacturing simplicity (46), make dry-powder WIV an apt candidate formulation for pre-pandemic stockpiling.
The rationale for reporting these two studies together is to characterize the immunogenicity, reactogenicity, and safety of the QIV candidate formulation alongside that of the TIV to evaluate the acceptability of the new manufacturing process particularly regarding the European Union Committee for Medicinal Products for Human Use (CHMP) immunogenicity acceptance criteria.
Section 4 elaborates candidates' formulations, their parameter estimation, and an algorithm for exploring the best-fitted candidate.
67 (1993) 438) and have been included in candidate vaccine formulations.
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