scholarly journals Uncertainty of Size-Exclusion Chromatography Method in Quality Control of Bevacizumab Batches

Separations ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 133
Author(s):  
Alexis Oliva ◽  
Matías Llabrés
Keyword(s):  
Manufacturing Process ◽  
Variance Components ◽  
Control Process ◽  
Real Data ◽  
Size Exclusion ◽  
Likelihood Method ◽  
Monitoring And Control ◽  
Chromatography Method ◽  
Validation Data ◽  
Specification Limits

In addition to the analytical challenges related to the size and complexity of biopharmaceutical drugs, the inherent variability that arises due to their manufacturing process requires monitoring throughout the production process to ensure the safety and efficacy of the finished product. In this step, validation data should demonstrate that the process is controlled and reproducible, whereas the manufacturing process must ensure the quality and consistency of the product. For this, the manufacturer sets specification limits according with regulatory guidance. In such a situation, the comparison of different batches is required in order to describe and analyze the variability between them. However, it is unclear how great the variability of the analytical method would be or that in producing the batches. The estimation of the β-expectation tolerance intervals based on the variance components to account for both between-batch and within-batch variability was proposed as a specification limit to control the heterogeneity between batches at the time of manufacture and to verify whether batches meet specification limits. At this point, the variance components were computed by the maximum likelihood method using a linear random model. For this, the protein content, expressed as a percentage of the actual concentration relative to the claim value, and the dimer content (expressed as percentage) were used as critical quality attributes (CQAs) in the monitoring and control process. We used real data from six bevacizumab commercial batches.

scholarly journals Genetic parameters for weight, morphometry and oviposition of Africanized honeybee queens using simulated data

2020 ◽  
Vol 72 (5) ◽  
pp. 1959-1964
Author(s):  
E.H. Martins ◽  
G. Tarôco ◽  
G.A. Rovadoscki ◽  
M.H.V. Oliveira ◽  
G.B. Mourão ◽  
...  
Keyword(s):  
Variance Components ◽  
Genetic Parameters ◽  
Genetic Correlations ◽  
Simulated Data ◽  
Real Data ◽  
Biological Data ◽  
Likelihood Method ◽  
Phenotypic Correlations ◽  
Genetic Evaluations ◽  
The Impact

ABSTRACT This study aimed to estimate genetic parameters for simulated data of body weight (BW), abdominal width (AW), abdominal length (AL), and oviposition. Simulation was performed based on real data collected at apiaries in the region of Campo das Vertentes, Minas Gerais, Brazil. Genetic evaluations were performed using single- and two-trait models and (co)variance components were estimated by the restricted maximum likelihood method. The heritability for BW, AW, AL and oviposition were 0.54, 0.47, 0.31 and 0.66, respectively. Positive genetic correlations of high magnitude were obtained between BW and AW (0.80), BW and oviposition (0.69), AW and oviposition (0.82), and AL and oviposition (0.96). The genetic correlations between BW and AL (0.11) and between AW and AL (0.26) were considered moderate and low. In contrast, the phenotypic correlations were positive and high between BW and AW (0.97), BW and AL (0.96), and AW and AL (0.98). Phenotypic correlations of low magnitude and close to zero were obtained for oviposition with AL (0.02), AW (-0.02), and BW (-0.03). New studies involving these characteristics should be conducted on populations with biological data in order to evaluate the impact of selection on traits of economic interest.

scholarly journals New Method for Generating New Families of Distributions

Symmetry ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 726
Author(s):  
Lamya A. Baharith ◽  
Wedad H. Aljuhani
Keyword(s):  
Exponential Distribution ◽  
Real Data ◽  
Rate Function ◽  
New Method ◽  
Likelihood Method ◽  
Alpha Power ◽  
Unknown Parameters ◽  
Failure Rate Function ◽  
New Approach ◽  
Numerical Studies

This article presents a new method for generating distributions. This method combines two techniques—the transformed—transformer and alpha power transformation approaches—allowing for tremendous flexibility in the resulting distributions. The new approach is applied to introduce the alpha power Weibull—exponential distribution. The density of this distribution can take asymmetric and near-symmetric shapes. Various asymmetric shapes, such as decreasing, increasing, L-shaped, near-symmetrical, and right-skewed shapes, are observed for the related failure rate function, making it more tractable for many modeling applications. Some significant mathematical features of the suggested distribution are determined. Estimates of the unknown parameters of the proposed distribution are obtained using the maximum likelihood method. Furthermore, some numerical studies were carried out, in order to evaluate the estimation performance. Three practical datasets are considered to analyze the usefulness and flexibility of the introduced distribution. The proposed alpha power Weibull–exponential distribution can outperform other well-known distributions, showing its great adaptability in the context of real data analysis.

Analysis of the information management system in the manufacturing process of cigarette enterprises using fuzzy AHP

2021 ◽  
pp. 1-11
Author(s):  
Song Gang ◽  
Wang Xiaoming ◽  
Wu Junfeng ◽  
Li Shufang ◽  
Liu Zhuowen ◽  
...  
Keyword(s):  
Quality Control ◽  
Production Process ◽  
Information Management ◽  
Manufacturing Process ◽  
Management System ◽  
Fuzzy Ahp ◽  
Control Process ◽  
Information Management System ◽  
Manufacturing Execution System ◽  
Quality Control Process

In view of the production quality management of filter rods in the manufacturing and execution process of cigarette enterprises, this paper analyzes the necessity of implementing the manufacturing execution system (MES) in the production process of filter rods. In this paper, the filter rod quality system of cigarette enterprise based on MES is fully studied, and the constructive information management system demand analysis, cigarette quality control process, system function module design, implementation and test effect are given. This paper utilizes the Fuzzy analytic hierarchy process to find the optimal system for processing the manufacturing of cigarette. The implementation of MSE based filter rod quality information management system for a cigarette enterprise ensures the quality control in the cigarette production process. Through visualization, real-time and dynamic way, the information management of cigarette production is completed, which greatly improves the quality of cigarette enterprise manufacturing process.

scholarly journals The Censored Beta-Skew Alpha-Power Distribution

Symmetry ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1114
Author(s):  
Guillermo Martínez-Flórez ◽  
Roger Tovar-Falón ◽  
María Martínez-Guerra
Keyword(s):  
Power Distribution ◽  
Information Matrix ◽  
Real Data ◽  
Likelihood Method ◽  
Data Sets ◽  
Alpha Power ◽  
Score Functions ◽  
New Family ◽  
Two Parameters ◽  
Family Of Distributions

This paper introduces a new family of distributions for modelling censored multimodal data. The model extends the widely known tobit model by introducing two parameters that control the shape and the asymmetry of the distribution. Basic properties of this new family of distributions are studied in detail and a model for censored positive data is also studied. The problem of estimating parameters is addressed by considering the maximum likelihood method. The score functions and the elements of the observed information matrix are given. Finally, three applications to real data sets are reported to illustrate the developed methodology.

scholarly journals Theory and Applications of the Unit Gamma/Gompertz Distribution

Mathematics ◽  
2021 ◽  
Vol 9 (16) ◽  
pp. 1850
Author(s):  
Rashad A. R. Bantan ◽  
Farrukh Jamal ◽  
Christophe Chesneau ◽  
Mohammed Elgarhy
Keyword(s):  
Stochastic Ordering ◽  
Real Data ◽  
Rate Function ◽  
The Other ◽  
Likelihood Method ◽  
Model Parameters ◽  
Data Sets ◽  
Gompertz Distribution ◽  
Probability And Statistics ◽  
Analytical Behavior

Unit distributions are commonly used in probability and statistics to describe useful quantities with values between 0 and 1, such as proportions, probabilities, and percentages. Some unit distributions are defined in a natural analytical manner, and the others are derived through the transformation of an existing distribution defined in a greater domain. In this article, we introduce the unit gamma/Gompertz distribution, founded on the inverse-exponential scheme and the gamma/Gompertz distribution. The gamma/Gompertz distribution is known to be a very flexible three-parameter lifetime distribution, and we aim to transpose this flexibility to the unit interval. First, we check this aspect with the analytical behavior of the primary functions. It is shown that the probability density function can be increasing, decreasing, “increasing-decreasing” and “decreasing-increasing”, with pliant asymmetric properties. On the other hand, the hazard rate function has monotonically increasing, decreasing, or constant shapes. We complete the theoretical part with some propositions on stochastic ordering, moments, quantiles, and the reliability coefficient. Practically, to estimate the model parameters from unit data, the maximum likelihood method is used. We present some simulation results to evaluate this method. Two applications using real data sets, one on trade shares and the other on flood levels, demonstrate the importance of the new model when compared to other unit models.

scholarly journals Hyperbolastic Models from a Stochastic Differential Equation Point of View

Mathematics ◽  
2021 ◽  
Vol 9 (16) ◽  
pp. 1835
Author(s):  
Antonio Barrera ◽  
Patricia Román-Román ◽  
Francisco Torres-Ruiz
Keyword(s):  
Differential Equation ◽  
Simulated Data ◽  
Real Data ◽  
Point Of View ◽  
Likelihood Method ◽  
Numerical Resolution ◽  
The Family ◽  
The Common ◽  
Linear Differential ◽  
Mean Function

A joint and unified vision of stochastic diffusion models associated with the family of hyperbolastic curves is presented. The motivation behind this approach stems from the fact that all hyperbolastic curves verify a linear differential equation of the Malthusian type. By virtue of this, and by adding a multiplicative noise to said ordinary differential equation, a diffusion process may be associated with each curve whose mean function is said curve. The inference in the resulting processes is presented jointly, as well as the strategies developed to obtain the initial solutions necessary for the numerical resolution of the system of equations resulting from the application of the maximum likelihood method. The common perspective presented is especially useful for the implementation of the necessary procedures for fitting the models to real data. Some examples based on simulated data support the suitability of the development described in the present paper.

scholarly journals Robust estimation for multivariate wrapped models

METRON ◽  
2021 ◽  
Author(s):  
Giovanni Saraceno ◽  
Claudio Agostinelli ◽  
Luca Greco
Keyword(s):  
Robust Estimation ◽  
Numerical Study ◽  
Real Data ◽  
Likelihood Method ◽  
Weighted Likelihood ◽  
Finite Sample ◽  
Pearson Residuals ◽  
Data Points ◽  
Wrapped Distributions ◽  
Standard Techniques

AbstractA weighted likelihood technique for robust estimation of multivariate Wrapped distributions of data points scattered on a $$p-$$ p - dimensional torus is proposed. The occurrence of outliers in the sample at hand can badly compromise inference for standard techniques such as maximum likelihood method. Therefore, there is the need to handle such model inadequacies in the fitting process by a robust technique and an effective downweighting of observations not following the assumed model. Furthermore, the employ of a robust method could help in situations of hidden and unexpected substructures in the data. Here, it is suggested to build a set of data-dependent weights based on the Pearson residuals and solve the corresponding weighted likelihood estimating equations. In particular, robust estimation is carried out by using a Classification EM algorithm whose M-step is enhanced by the computation of weights based on current parameters’ values. The finite sample behavior of the proposed method has been investigated by a Monte Carlo numerical study and real data examples.

Empirical Likelihood Testing for Longitudinal Varying Coefficient Models

2014 ◽  
Vol 518 ◽  
pp. 356-360
Author(s):  
Chang Qing Liu
Keyword(s):  
Data Analysis ◽  
Empirical Likelihood ◽  
Real Data ◽  
Likelihood Method ◽  
Varying Coefficient Models ◽  
Empirical Likelihood Method ◽  
Real Data Analysis ◽  
Varying Coefficient ◽  
Testing Method

By using the empirical likelihood method, a testing method is proposed for longitudinal varying coefficient models. Some simulations and a real data analysis are undertaken to investigate the power of the empirical likelihood based testing method.

scholarly journals Mixture of Inverse Weibull and Lognormal Distributions: Properties, Estimation, and Illustration

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
K. S. Sultan ◽  
A. S. Al-Moisheer
Keyword(s):  
Information Matrix ◽  
Real Data ◽  
Likelihood Method ◽  
Model Parameters ◽  
Component Mixture ◽  
Data Set ◽  
Hazard Functions ◽  
Lognormal Distributions ◽  
Proposed Model ◽  
Estimation Of Model Parameters

We discuss the two-component mixture of the inverse Weibull and lognormal distributions (MIWLND) as a lifetime model. First, we discuss the properties of the proposed model including the reliability and hazard functions. Next, we discuss the estimation of model parameters by using the maximum likelihood method (MLEs). We also derive expressions for the elements of the Fisher information matrix. Next, we demonstrate the usefulness of the proposed model by fitting it to a real data set. Finally, we draw some concluding remarks.

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