This document discusses factorial design, which is an experimental design technique used for optimization. It involves studying the effects of two or more factors simultaneously. There are two main types: full factorial design, which tests all possible combinations of factors and levels, and fractional factorial design, which reduces the number of runs when there are many factors. Factorial designs allow evaluation of both main effects and interaction effects. They are useful for formulation development and method optimization in chromatography. Software is used to analyze the results of factorial experiments.
This document discusses various optimization techniques used in pharmaceutical development. It begins with defining optimization and providing an outline of topics to be covered, including key terms, parameters, experimental designs, applied methods, and references. Experimental designs discussed include factorial, response surface, central composite, Box-Behnken, Plackett-Burman, and Taguchi designs. Applied optimization methods include classic optimization techniques using calculus as well as statistical methods like EVOP. The objective of pharmaceutical optimization is to develop the optimal formulation while reducing costs through fewer experiments.
Concept of optimization, optimization parameters and factorial designManikant Prasad Shah
Optimization involves systematically designing experiments to improve formulations by accounting for all influencing factors. Factorial design is a technique used in optimization that involves studying the effect of multiple factors simultaneously. It depends on factors, their levels, and variables. There are two main types of factorial design: full factorial design and fractional factorial design. Full factorial design tests every combination of factors and levels but becomes impractical with more than 5 factors. Fractional factorial design reduces the number of runs needed to study many factors.
Chetan dhal-Optimization techniques in pharmaceutics, formulation and processingChetan Dhal
This document provides an overview of optimization techniques used in pharmaceutical formulation and processing. It discusses key optimization parameters like variables (independent and dependent) and problem types (constrained and unconstrained). Classical optimization methods like response surface methodology are described. The document focuses on experimental design techniques like factorial designs (full and fractional), response surface methodology using central composite design and Box-Behnken design, and adding center points. It provides examples of different types of experimental designs and how they are used to optimize pharmaceutical processes and formulations.
Optimizationinpharmaceuticsprocessing SIDDANNA M BALAPGOLSiddanna Balapgol
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The goal is to make the formulation or process as effective as possible given existing constraints. Modern optimization uses systematic experimental design (DoE) to understand the effects of multiple variables and their interactions on a response. Key aspects of optimization include identifying independent variables that can be modified, dependent response variables to measure effects, and using statistical techniques like factorial designs to efficiently gather information on variable effects and optimize the system. Optimization aims to find the best settings for variables to achieve a desired response.
The document discusses optimization in pharmaceutical formulation and processing. It defines optimization as choosing the best alternative from available options. Optimization in pharmacy involves formulating drug products using the best combination of ingredients and processing parameters. Experimental design techniques are used to optimize multiple variables. Response surface methodology and central composite designs are commonly used to model quadratic relationships between variables. The document outlines different types of experimental designs and their applications in pharmaceutical optimization.
This document provides information on design of experiments (DOE). It discusses the objectives of experiments including determining influential variables and their optimal settings. It defines key terms like factors, levels, effects, and treatments. Factorial and fractional factorial experiment designs are explained. Examples of 2-level factor experiments are provided and the calculation of main effects and interactions are shown. The document also discusses regression models in DOE and assessing model adequacy through residuals.
Factorial design ,full factorial design, fractional factorial designSayed Shakil Ahmed
This document discusses factorial designs and their application in formulation. It defines factorial experiments as those involving two or more factors, each with different levels. Full factorial designs involve every combination of all factors and levels, while fractional factorial designs examine multiple factors efficiently with fewer runs. Applications mentioned include formulation and processing, clinical chemistry, and studying the effects of factors like disintegrant and lubricant concentration on tablet dissolution. IVIVC and BCS classification are also discussed in relation to predicting oral absorption of immediate release formulations.
This document discusses factorial design, which is an experimental design technique used for optimization. It involves studying the effects of two or more factors simultaneously. There are two main types: full factorial design, which tests all possible combinations of factors and levels, and fractional factorial design, which reduces the number of runs when there are many factors. Factorial designs allow evaluation of both main effects and interaction effects. They are useful for formulation development and method optimization in chromatography. Software is used to analyze the results of factorial experiments.
This document discusses various optimization techniques used in pharmaceutical development. It begins with defining optimization and providing an outline of topics to be covered, including key terms, parameters, experimental designs, applied methods, and references. Experimental designs discussed include factorial, response surface, central composite, Box-Behnken, Plackett-Burman, and Taguchi designs. Applied optimization methods include classic optimization techniques using calculus as well as statistical methods like EVOP. The objective of pharmaceutical optimization is to develop the optimal formulation while reducing costs through fewer experiments.
Concept of optimization, optimization parameters and factorial designManikant Prasad Shah
Optimization involves systematically designing experiments to improve formulations by accounting for all influencing factors. Factorial design is a technique used in optimization that involves studying the effect of multiple factors simultaneously. It depends on factors, their levels, and variables. There are two main types of factorial design: full factorial design and fractional factorial design. Full factorial design tests every combination of factors and levels but becomes impractical with more than 5 factors. Fractional factorial design reduces the number of runs needed to study many factors.
Chetan dhal-Optimization techniques in pharmaceutics, formulation and processingChetan Dhal
This document provides an overview of optimization techniques used in pharmaceutical formulation and processing. It discusses key optimization parameters like variables (independent and dependent) and problem types (constrained and unconstrained). Classical optimization methods like response surface methodology are described. The document focuses on experimental design techniques like factorial designs (full and fractional), response surface methodology using central composite design and Box-Behnken design, and adding center points. It provides examples of different types of experimental designs and how they are used to optimize pharmaceutical processes and formulations.
Optimizationinpharmaceuticsprocessing SIDDANNA M BALAPGOLSiddanna Balapgol
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The goal is to make the formulation or process as effective as possible given existing constraints. Modern optimization uses systematic experimental design (DoE) to understand the effects of multiple variables and their interactions on a response. Key aspects of optimization include identifying independent variables that can be modified, dependent response variables to measure effects, and using statistical techniques like factorial designs to efficiently gather information on variable effects and optimize the system. Optimization aims to find the best settings for variables to achieve a desired response.
The document discusses optimization in pharmaceutical formulation and processing. It defines optimization as choosing the best alternative from available options. Optimization in pharmacy involves formulating drug products using the best combination of ingredients and processing parameters. Experimental design techniques are used to optimize multiple variables. Response surface methodology and central composite designs are commonly used to model quadratic relationships between variables. The document outlines different types of experimental designs and their applications in pharmaceutical optimization.
This document provides information on design of experiments (DOE). It discusses the objectives of experiments including determining influential variables and their optimal settings. It defines key terms like factors, levels, effects, and treatments. Factorial and fractional factorial experiment designs are explained. Examples of 2-level factor experiments are provided and the calculation of main effects and interactions are shown. The document also discusses regression models in DOE and assessing model adequacy through residuals.
Factorial design ,full factorial design, fractional factorial designSayed Shakil Ahmed
This document discusses factorial designs and their application in formulation. It defines factorial experiments as those involving two or more factors, each with different levels. Full factorial designs involve every combination of all factors and levels, while fractional factorial designs examine multiple factors efficiently with fewer runs. Applications mentioned include formulation and processing, clinical chemistry, and studying the effects of factors like disintegrant and lubricant concentration on tablet dissolution. IVIVC and BCS classification are also discussed in relation to predicting oral absorption of immediate release formulations.
computer aided formulation developmentSUJITHA MARY
The document discusses optimization techniques used in computer aided formulation development. It defines optimization as choosing the best alternative while considering all influencing factors. Optimization techniques help minimize experimental trials, reduce costs and save time compared to traditional trial and error methods. The document describes various experimental design approaches like factorial designs, response surface methodology and mixture designs that are used to optimize formulations. It also discusses simultaneous techniques like evolutionary operations and simplex method as well as sequential techniques like mathematical modeling and search methods. Optimization is important for developing formulations with desired performance and ensuring reproducible, large-scale manufacturing.
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The primary goal may not be absolute optimization but rather an effective compromise that produces the best formulation given certain restrictions. Optimization involves systematically varying factors like concentration, temperature, and polymer grade to determine their effects on responses such as dissolution time, hardness, and reproducibility. Statistical experimental designs are commonly used for optimization and include factorial, response surface, and block designs. These designs help establish relationships between independent variables and dependent responses to find the ideal formulation parameters.
Optimization techniques are used to improve pharmaceutical formulations by systematically varying factors and measuring responses. Statistical experimental designs are important tools for optimization that involve planning experiments to determine relationships between factors and responses. Common statistical designs include factorial designs, which examine multiple factors simultaneously, and response surface designs that model those relationships to find optimal conditions. The goal of optimization is to develop the best formulation possible given restrictions, with the primary objective being to improve quality, efficacy or reduce costs rather than absolutely optimize.
Optimization technique is a rational approach for selecting the excipients, their concentrations and process conditions for obtaining the best possible product satisfying the quality characteristics.
Optimization is an act, process or methodology of making design, system or decisions as fully perfect, functional or as effective as possible.
This document discusses optimization techniques used in pharmaceutical formulations. It begins with defining optimization and describing how experimental design can be used to shorten experimentation time. It then covers various optimization parameters, classic optimization methods using calculus, and common optimization methods like factorial designs, response surface methodology, and simplex lattice designs. Applications mentioned include improving process yield, reducing costs and development time. Finally, some commonly used software for optimization is listed along with references.
Factorial Design:- It identifies the chance variation ( present in the process
due to accident) and the assignable variations ( which
are due to specific cause.)
• Factorial design are helpful to deduce IVIVC.
• IVIVC are helpful to serve a surrogate measure of rate
and extent of oral absorption.
• BCS classification is based on solubility and permeability
issue of drugs, which are predictive of IVIVC.
• Sound IVIVC omits the need of bioequivalence study.
• IVIVC is predicted at three levels:
• Level A- point to point relationship of in vitro
dissolution and in vivo performance.
• Level B- mean in vitro and mean in vivo dissolution is
compared and co-related.
• Level C- correlation between the amount of drug dissolved
at one time and one pharmacokinetic parameter is
deduced.
TYPES OF FACTORIAL DESIGN (FD)
1. Full Factorial Design(FD)
a. Two Levels Full FD
b. Three level Full FD
2. Fractional Factorial Design
a. Homogenous fractional
b. Mixed level fractional
c. Box-Hunter
d. Plackett - Burman
e. Taguchi
f. Latin square
Full Factorial Design
• A design in which every setting of every factor
appears with setting of every other factor is
full factorial design
• If there is k factor , each at Z level , a Full FD
has zk
(Levels)factor zk
Factorial Design :22 23 32 33
22 FD = 2 Factors , 2 Levels = 4 runs
23 FD = 3 Factors , 2 Levels = 8 runs
32 FD = 2 Factors , 3 Levels = 9 runs
33 FD = 3 factors , 3 Levels = 27 runs
• TWO Levels Full FD :
2 factors : X1 and X2 (Independent variables)
2 levels : Low and High + -
Coding : (-1) LOW , (+1) HIGH
Three level Full FD :
In three level factorial design ,
three levels are use ,
1) low (-1)
2) intermediate (0)
3) high (+1)
• It is written as 3k factorial design.
• It means that k factors are considered each at 3
levels.
• These are usually referred to as low, intermediate
• & high values.
• These values are usually expressed as 0, 1 & 2
• The third level for a continuous factor facilitates
investigation of a quadratic relationship between the
response and each of the factors
Factorial Design :22 23 32 33
22 FD = 2 Factors , 2 Levels = 4 runs
23 FD = 3 Factors , 2 Levels = 8 runs
32 FD = 2 Factors , 3 Levels = 9 runs
33 FD = 3 factors , 3 Levels = 27 runs
• TWO Levels Full FD :
2 factors : X1 and X2 (Independent variables)
2 levels : Low and High + -
Coding : (-1) LOW , (+1) HIGH
Three level Full FD :
In three level factorial design ,
three levels are use ,
1) low (-1)
2) intermediate (0)
3) high (+1)
• It is written as 3k factorial design.
• It means that k factors are considered each at 3
levels.
• These are usually referred to as low, intermediate
• & high values.
• These values are usually expressed as 0, 1 & 2
• The third level for a continuous factor facilitates
investigation of a quadratic relationship between the
response and each of the factors
Homogenous fractional
• Useful when large number of factors must be
screened
Mixed level fractional
• Useful when variety of factors needed to be
evaluated fo
Optimization in pharmaceutics & processingJamia Hamdard
Optimization techniques are used to develop pharmaceutical formulations that are effective and functional while using resources efficiently. Statistical experimental design techniques help identify the key factors that influence a formulation or process and their optimal levels. Response surface methodology uses designs like central composite designs to understand the relationship between multiple factors and responses and identify optimal conditions. Optimization methods like evolutionary operations and simplex lattice testing are applied to iteratively improve formulations or processes through small, statistically analyzed changes until no further improvement is possible.
Design Of Experiments (DOE) Applied To Pharmaceutical and Analytical QbD.SALMA RASHID SHAIKH
According to ICH Q8 Quality should be built into the product.
Design of Experiments (DoE) generate knowledge about a product or process and established a Mathematical relationship of dependent variables and independent variables.
The most common screening designs, such as two-level full factorial, fractionate factorial, and Plackett- Burman designs.
Optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs.
Analysis of variance (ANOVA) used in multiple regression analysis to evaluate regression significance, residual error, and lack-of-fit adjustment.
Determination coefficients (R2, R2 -adj, and R2 -pred) is also evaluated.
Quality By Design:
QbD is “a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”
Goals Of Pharmaceutical QbD:
To achieve meaningful product quality specifications
To increase process capability and reduce product variability
To increase pharmaceutical development and manufacturing efficiencies and
To enhance cause-effect analysis and regulatory flexibility.
Introduction & Basics of DoE
Terminologies
Key steps in DOE
Softwares used for DOE
Factorial Designs ( Full and Fractional)
Mixture Designs
Response Surface Methodology
Central Composite Design
Box -Behnken Design
Conclusion
References
Optimization in pharmaceutics & processingJamia Hamdard
The document discusses various optimization techniques used in pharmaceutical formulation, processing, and manufacturing. It describes techniques like evolutionary operations, simplex methods, and statistical experimental designs that are used to optimize factors in pharmaceutical experiments to develop formulations with desirable responses. The document also provides examples of applying these techniques to optimize different variables like concentration levels, processing parameters, and component ratios.
OPTIMIZATION IN PHARMACEUTICS,FORMULATION & PROCESSINGJamia Hamdard
Optimization techniques are used in pharmaceutical formulation, processing, and manufacturing to improve quality and efficiency. Statistical experimental design techniques like factorial designs and response surface methodology are commonly used to optimize multiple variables and their interactions. These techniques generate mathematical models to describe the response based on the variables, which can then be analyzed to find the optimum conditions. Common optimization methods include evolutionary operations, simplex lattice, and gradient search algorithms, with the simplex method being widely applied for analytical problems involving a small number of variables.
The document discusses optimization techniques used in pharmaceutical formulation and processing. It describes how optimization aims to find the best formulation and processing conditions by systematically varying factors and levels. Various experimental designs like factorial designs and response surface methodology are used to optimize multiple variables. Optimization helps develop formulations that meet requirements while allowing efficient mass production.
Optimization technology and screening design sathish h tSatishHT1
This document discusses various design of experiment methodologies including screening designs and optimization designs. It provides examples of factorial designs, response surface designs like central composite designs and Box-Behnken designs, and three-level full factorial designs. It also gives an example of using a fractional factorial design to screen critical processing parameters in a wet granulation coating process and selecting a three-level full factorial design to optimize two factors, blending speed and time, in a dry mixing process to investigate their interactive and quadratic effects on the response.
Optimization refers to changing variables to improve problematic solutions by reducing costs, errors, and time while improving safety, reproducibility, and innovation. Key aspects of optimization include factors, levels, responses, effects, interactions, coding, experimental design, response surfaces, mathematical models, parameters, variables, and steps. Experimental designs help obtain necessary information efficiently by systematically varying factors and levels, and include completely randomized, randomized block, factorial, and response surface designs like central composite and Box-Behnken designs. The objective is to understand relationships between variables and develop models to find optimal values.
This document discusses optimization techniques used in pharmaceutical development. It defines optimization as making a formulation or process perfect by finding the best use of resources while considering all influencing factors. It describes independent and dependent variables, different optimization methods like evolutionary operation, simplex method, and statistical experimental designs including factorial, response surface, and Plackett-Burman designs. The advantages of optimization include determining important variables, measuring interactions, and allowing extrapolation to find the best product. Optimization has applications in formulation development, dissolution testing, tablet coating, and capsule preparation.
OPTIMIZATION TECHNIQUES IN PHARMACEUTICAL SCIENCESprasad_bsreegiri
This document provides an overview of optimization in pharmaceutical formulations and processes. It defines optimization and discusses optimization parameters such as independent and dependent variables. It also describes various optimization methods including classical optimization, statistical design of experiments, evolutionary operations, simplex method, and Lagrangian method. Statistical design of experiments involves factorial designs, response surface designs, and other experimental designs. The overall goal of optimization is to develop a formulation or process that meets requirements in a cost-effective and efficient manner.
The document discusses experimental design and outlines several types of designs:
1) One factor designs investigate the effect of changing a single factor on the response.
2) Factorial designs study the effects of multiple factors simultaneously. Full factorial designs test all possible combinations of factors and levels. Two-level factorial designs restrict factors to two levels.
3) Fractional factorial designs test only a fraction of all possible factor level combinations to reduce the number of required experiments. Taguchi orthogonal arrays are highly fractional designs that estimate main effects using few experimental runs.
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It begins with introducing concepts of optimization and defining optimization parameters such as independent and dependent variables. It then describes different experimental design approaches including classical optimization, statistical design of experiments, and various optimization methods like evolutionary operations, simplex method, and Lagrangian method. Specific examples are provided to illustrate full factorial design and simplex optimization approach.
This document discusses design of experiments (DOE) and summarizes several key aspects:
- DOE is a statistical methodology that aims to obtain maximum information from experiments using a minimum number of trials. It recognizes major factors that affect experimental outcomes.
- Factors are input variables that can be changed, and have different levels. Full factorial designs involve varying one factor at a time through all levels of all factors. Taguchi methods use orthogonal arrays to study multiple factors simultaneously.
- The document provides examples of orthogonal arrays like L4, L8, and L9 that can be used for experiments with different numbers of factors and levels. It also outlines the general steps of Taguchi method DOE including defining objectives
Quality-by-Design In Pharmaceutical DevelopmentPrabhjot kaur
Quality-by-Design In Pharmaceutical Development: Introduction, ICH Q8 guideline, Regulatory and industry views on QbD, Scientifically based QbD - examples of application. M. Pharmacy 2nd Semester (Computer aided drug delivery system)
computer aided formulation developmentSUJITHA MARY
The document discusses optimization techniques used in computer aided formulation development. It defines optimization as choosing the best alternative while considering all influencing factors. Optimization techniques help minimize experimental trials, reduce costs and save time compared to traditional trial and error methods. The document describes various experimental design approaches like factorial designs, response surface methodology and mixture designs that are used to optimize formulations. It also discusses simultaneous techniques like evolutionary operations and simplex method as well as sequential techniques like mathematical modeling and search methods. Optimization is important for developing formulations with desired performance and ensuring reproducible, large-scale manufacturing.
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The primary goal may not be absolute optimization but rather an effective compromise that produces the best formulation given certain restrictions. Optimization involves systematically varying factors like concentration, temperature, and polymer grade to determine their effects on responses such as dissolution time, hardness, and reproducibility. Statistical experimental designs are commonly used for optimization and include factorial, response surface, and block designs. These designs help establish relationships between independent variables and dependent responses to find the ideal formulation parameters.
Optimization techniques are used to improve pharmaceutical formulations by systematically varying factors and measuring responses. Statistical experimental designs are important tools for optimization that involve planning experiments to determine relationships between factors and responses. Common statistical designs include factorial designs, which examine multiple factors simultaneously, and response surface designs that model those relationships to find optimal conditions. The goal of optimization is to develop the best formulation possible given restrictions, with the primary objective being to improve quality, efficacy or reduce costs rather than absolutely optimize.
Optimization technique is a rational approach for selecting the excipients, their concentrations and process conditions for obtaining the best possible product satisfying the quality characteristics.
Optimization is an act, process or methodology of making design, system or decisions as fully perfect, functional or as effective as possible.
This document discusses optimization techniques used in pharmaceutical formulations. It begins with defining optimization and describing how experimental design can be used to shorten experimentation time. It then covers various optimization parameters, classic optimization methods using calculus, and common optimization methods like factorial designs, response surface methodology, and simplex lattice designs. Applications mentioned include improving process yield, reducing costs and development time. Finally, some commonly used software for optimization is listed along with references.
Factorial Design:- It identifies the chance variation ( present in the process
due to accident) and the assignable variations ( which
are due to specific cause.)
• Factorial design are helpful to deduce IVIVC.
• IVIVC are helpful to serve a surrogate measure of rate
and extent of oral absorption.
• BCS classification is based on solubility and permeability
issue of drugs, which are predictive of IVIVC.
• Sound IVIVC omits the need of bioequivalence study.
• IVIVC is predicted at three levels:
• Level A- point to point relationship of in vitro
dissolution and in vivo performance.
• Level B- mean in vitro and mean in vivo dissolution is
compared and co-related.
• Level C- correlation between the amount of drug dissolved
at one time and one pharmacokinetic parameter is
deduced.
TYPES OF FACTORIAL DESIGN (FD)
1. Full Factorial Design(FD)
a. Two Levels Full FD
b. Three level Full FD
2. Fractional Factorial Design
a. Homogenous fractional
b. Mixed level fractional
c. Box-Hunter
d. Plackett - Burman
e. Taguchi
f. Latin square
Full Factorial Design
• A design in which every setting of every factor
appears with setting of every other factor is
full factorial design
• If there is k factor , each at Z level , a Full FD
has zk
(Levels)factor zk
Factorial Design :22 23 32 33
22 FD = 2 Factors , 2 Levels = 4 runs
23 FD = 3 Factors , 2 Levels = 8 runs
32 FD = 2 Factors , 3 Levels = 9 runs
33 FD = 3 factors , 3 Levels = 27 runs
• TWO Levels Full FD :
2 factors : X1 and X2 (Independent variables)
2 levels : Low and High + -
Coding : (-1) LOW , (+1) HIGH
Three level Full FD :
In three level factorial design ,
three levels are use ,
1) low (-1)
2) intermediate (0)
3) high (+1)
• It is written as 3k factorial design.
• It means that k factors are considered each at 3
levels.
• These are usually referred to as low, intermediate
• & high values.
• These values are usually expressed as 0, 1 & 2
• The third level for a continuous factor facilitates
investigation of a quadratic relationship between the
response and each of the factors
Factorial Design :22 23 32 33
22 FD = 2 Factors , 2 Levels = 4 runs
23 FD = 3 Factors , 2 Levels = 8 runs
32 FD = 2 Factors , 3 Levels = 9 runs
33 FD = 3 factors , 3 Levels = 27 runs
• TWO Levels Full FD :
2 factors : X1 and X2 (Independent variables)
2 levels : Low and High + -
Coding : (-1) LOW , (+1) HIGH
Three level Full FD :
In three level factorial design ,
three levels are use ,
1) low (-1)
2) intermediate (0)
3) high (+1)
• It is written as 3k factorial design.
• It means that k factors are considered each at 3
levels.
• These are usually referred to as low, intermediate
• & high values.
• These values are usually expressed as 0, 1 & 2
• The third level for a continuous factor facilitates
investigation of a quadratic relationship between the
response and each of the factors
Homogenous fractional
• Useful when large number of factors must be
screened
Mixed level fractional
• Useful when variety of factors needed to be
evaluated fo
Optimization in pharmaceutics & processingJamia Hamdard
Optimization techniques are used to develop pharmaceutical formulations that are effective and functional while using resources efficiently. Statistical experimental design techniques help identify the key factors that influence a formulation or process and their optimal levels. Response surface methodology uses designs like central composite designs to understand the relationship between multiple factors and responses and identify optimal conditions. Optimization methods like evolutionary operations and simplex lattice testing are applied to iteratively improve formulations or processes through small, statistically analyzed changes until no further improvement is possible.
Design Of Experiments (DOE) Applied To Pharmaceutical and Analytical QbD.SALMA RASHID SHAIKH
According to ICH Q8 Quality should be built into the product.
Design of Experiments (DoE) generate knowledge about a product or process and established a Mathematical relationship of dependent variables and independent variables.
The most common screening designs, such as two-level full factorial, fractionate factorial, and Plackett- Burman designs.
Optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs.
Analysis of variance (ANOVA) used in multiple regression analysis to evaluate regression significance, residual error, and lack-of-fit adjustment.
Determination coefficients (R2, R2 -adj, and R2 -pred) is also evaluated.
Quality By Design:
QbD is “a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”
Goals Of Pharmaceutical QbD:
To achieve meaningful product quality specifications
To increase process capability and reduce product variability
To increase pharmaceutical development and manufacturing efficiencies and
To enhance cause-effect analysis and regulatory flexibility.
Introduction & Basics of DoE
Terminologies
Key steps in DOE
Softwares used for DOE
Factorial Designs ( Full and Fractional)
Mixture Designs
Response Surface Methodology
Central Composite Design
Box -Behnken Design
Conclusion
References
Optimization in pharmaceutics & processingJamia Hamdard
The document discusses various optimization techniques used in pharmaceutical formulation, processing, and manufacturing. It describes techniques like evolutionary operations, simplex methods, and statistical experimental designs that are used to optimize factors in pharmaceutical experiments to develop formulations with desirable responses. The document also provides examples of applying these techniques to optimize different variables like concentration levels, processing parameters, and component ratios.
OPTIMIZATION IN PHARMACEUTICS,FORMULATION & PROCESSINGJamia Hamdard
Optimization techniques are used in pharmaceutical formulation, processing, and manufacturing to improve quality and efficiency. Statistical experimental design techniques like factorial designs and response surface methodology are commonly used to optimize multiple variables and their interactions. These techniques generate mathematical models to describe the response based on the variables, which can then be analyzed to find the optimum conditions. Common optimization methods include evolutionary operations, simplex lattice, and gradient search algorithms, with the simplex method being widely applied for analytical problems involving a small number of variables.
The document discusses optimization techniques used in pharmaceutical formulation and processing. It describes how optimization aims to find the best formulation and processing conditions by systematically varying factors and levels. Various experimental designs like factorial designs and response surface methodology are used to optimize multiple variables. Optimization helps develop formulations that meet requirements while allowing efficient mass production.
Optimization technology and screening design sathish h tSatishHT1
This document discusses various design of experiment methodologies including screening designs and optimization designs. It provides examples of factorial designs, response surface designs like central composite designs and Box-Behnken designs, and three-level full factorial designs. It also gives an example of using a fractional factorial design to screen critical processing parameters in a wet granulation coating process and selecting a three-level full factorial design to optimize two factors, blending speed and time, in a dry mixing process to investigate their interactive and quadratic effects on the response.
Optimization refers to changing variables to improve problematic solutions by reducing costs, errors, and time while improving safety, reproducibility, and innovation. Key aspects of optimization include factors, levels, responses, effects, interactions, coding, experimental design, response surfaces, mathematical models, parameters, variables, and steps. Experimental designs help obtain necessary information efficiently by systematically varying factors and levels, and include completely randomized, randomized block, factorial, and response surface designs like central composite and Box-Behnken designs. The objective is to understand relationships between variables and develop models to find optimal values.
This document discusses optimization techniques used in pharmaceutical development. It defines optimization as making a formulation or process perfect by finding the best use of resources while considering all influencing factors. It describes independent and dependent variables, different optimization methods like evolutionary operation, simplex method, and statistical experimental designs including factorial, response surface, and Plackett-Burman designs. The advantages of optimization include determining important variables, measuring interactions, and allowing extrapolation to find the best product. Optimization has applications in formulation development, dissolution testing, tablet coating, and capsule preparation.
OPTIMIZATION TECHNIQUES IN PHARMACEUTICAL SCIENCESprasad_bsreegiri
This document provides an overview of optimization in pharmaceutical formulations and processes. It defines optimization and discusses optimization parameters such as independent and dependent variables. It also describes various optimization methods including classical optimization, statistical design of experiments, evolutionary operations, simplex method, and Lagrangian method. Statistical design of experiments involves factorial designs, response surface designs, and other experimental designs. The overall goal of optimization is to develop a formulation or process that meets requirements in a cost-effective and efficient manner.
The document discusses experimental design and outlines several types of designs:
1) One factor designs investigate the effect of changing a single factor on the response.
2) Factorial designs study the effects of multiple factors simultaneously. Full factorial designs test all possible combinations of factors and levels. Two-level factorial designs restrict factors to two levels.
3) Fractional factorial designs test only a fraction of all possible factor level combinations to reduce the number of required experiments. Taguchi orthogonal arrays are highly fractional designs that estimate main effects using few experimental runs.
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It begins with introducing concepts of optimization and defining optimization parameters such as independent and dependent variables. It then describes different experimental design approaches including classical optimization, statistical design of experiments, and various optimization methods like evolutionary operations, simplex method, and Lagrangian method. Specific examples are provided to illustrate full factorial design and simplex optimization approach.
This document discusses design of experiments (DOE) and summarizes several key aspects:
- DOE is a statistical methodology that aims to obtain maximum information from experiments using a minimum number of trials. It recognizes major factors that affect experimental outcomes.
- Factors are input variables that can be changed, and have different levels. Full factorial designs involve varying one factor at a time through all levels of all factors. Taguchi methods use orthogonal arrays to study multiple factors simultaneously.
- The document provides examples of orthogonal arrays like L4, L8, and L9 that can be used for experiments with different numbers of factors and levels. It also outlines the general steps of Taguchi method DOE including defining objectives
Similar to Factorial Design (M. Pharmacy- 1st Semester) (20)
Quality-by-Design In Pharmaceutical DevelopmentPrabhjot kaur
Quality-by-Design In Pharmaceutical Development: Introduction, ICH Q8 guideline, Regulatory and industry views on QbD, Scientifically based QbD - examples of application. M. Pharmacy 2nd Semester (Computer aided drug delivery system)
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
How to Manage Reception Report in Odoo 17Celine George
A business may deal with both sales and purchases occasionally. They buy things from vendors and then sell them to their customers. Such dealings can be confusing at times. Because multiple clients may inquire about the same product at the same time, after purchasing those products, customers must be assigned to them. Odoo has a tool called Reception Report that can be used to complete this assignment. By enabling this, a reception report comes automatically after confirming a receipt, from which we can assign products to orders.
A Free 200-Page eBook ~ Brain and Mind Exercise.pptxOH TEIK BIN
(A Free eBook comprising 3 Sets of Presentation of a selection of Puzzles, Brain Teasers and Thinking Problems to exercise both the mind and the Right and Left Brain. To help keep the mind and brain fit and healthy. Good for both the young and old alike.
Answers are given for all the puzzles and problems.)
With Metta,
Bro. Oh Teik Bin 🙏🤓🤔🥰
THE SACRIFICE HOW PRO-PALESTINE PROTESTS STUDENTS ARE SACRIFICING TO CHANGE T...indexPub
The recent surge in pro-Palestine student activism has prompted significant responses from universities, ranging from negotiations and divestment commitments to increased transparency about investments in companies supporting the war on Gaza. This activism has led to the cessation of student encampments but also highlighted the substantial sacrifices made by students, including academic disruptions and personal risks. The primary drivers of these protests are poor university administration, lack of transparency, and inadequate communication between officials and students. This study examines the profound emotional, psychological, and professional impacts on students engaged in pro-Palestine protests, focusing on Generation Z's (Gen-Z) activism dynamics. This paper explores the significant sacrifices made by these students and even the professors supporting the pro-Palestine movement, with a focus on recent global movements. Through an in-depth analysis of printed and electronic media, the study examines the impacts of these sacrifices on the academic and personal lives of those involved. The paper highlights examples from various universities, demonstrating student activism's long-term and short-term effects, including disciplinary actions, social backlash, and career implications. The researchers also explore the broader implications of student sacrifices. The findings reveal that these sacrifices are driven by a profound commitment to justice and human rights, and are influenced by the increasing availability of information, peer interactions, and personal convictions. The study also discusses the broader implications of this activism, comparing it to historical precedents and assessing its potential to influence policy and public opinion. The emotional and psychological toll on student activists is significant, but their sense of purpose and community support mitigates some of these challenges. However, the researchers call for acknowledging the broader Impact of these sacrifices on the future global movement of FreePalestine.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
How to Setup Default Value for a Field in Odoo 17Celine George
In Odoo, we can set a default value for a field during the creation of a record for a model. We have many methods in odoo for setting a default value to the field.
Gender and Mental Health - Counselling and Family Therapy Applications and In...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
3. Introduction
• Optimisation Techniques
Optimization is choosing the best element from some set of available alternative. It is
the process of finding the best way of using the existing resources while taking in to
account all the factors that influence decision in any experiment. It is used for quality
selection.
• Factorial Design
Factorial design is an experiment which consist of two or more factors each with
different possible values or levels. It was introduced by fisher in 1926. It is applied in
optimization techniques.
4. Introduction
• Factorial Design
- By a factorial design , it is meant that in each complete trial or replication of the
experiment all possible combination of the levels of the factors are investigated.
- Eg: This is an example of a 2×2 factorial design because there are two independent
variables, each with two levels:
Dependent variable: Plant Growth
Independent variable #1: Sunlight
Levels: Low, High
Independent variable #2: Watering Frequency
Levels: Daily, Weekly
5. Terms Related to Factorial Design
Factors : The term factor is broadly used to include the independent variable that is manipulated
by the investigator in the experiment or that is manipulated through selection.
Main Effect : This is the simplest effect of a factor on a dependent variable. It is the effect of the
factor alone averaged across the level of other factors.
Interaction : When the effect of one independent variable depends on the level of another
independent variable. Types of interactions include: Antagonistic, Synergistic and Celling effect
interaction.
Randomisation : Randomisation is the process by which experimental units are allocated to
treatment; that is by a random process and not by any subjective process. The treatment should be
allocated to units in such a way that each treatment is equally likely to be applied to each unit.
Blocking: This is the procedure by which experimental units are grouped into homogenous cluster
in an attempt to improve the comparison of treatment by randomly allocating the treatment within
each cluster or block.
6. Types Of Factorial Design
Full Factorial and fractional factorial designs are two common methods of design of experiments
(DOE) in industrial engineering. DOE is a systematic approach to plan, conduct, and analyze
experiments that involve multiple factors and responses.
Full Factorial Design Fractional Factorial Design
- A design in which every setting of
every factor appears with setting of
every other factor is full factorial
design.
- If there is k factor, each at Z level,
a full FD has Zk.
- Number of runs (N) = y x
where , y = number of levels,
x = number of factors
E.g. 3 Factors, 2 levels each 23= 8
-In full FD, as a number of factor or
level increases ,the number of
experiment required exceeds to
unmanageable levels. In such cases ,
the number of experiment can be
reduced systematically and resulting
design is called as Fractional
Factorial Design (FFD).
-Applied if no. of factors are more
than 5.
7. Full Factorial Design Types
Two Levels Full FD
2 Factors: X1 and X1 (Independent variables)
2 levels : Low and High
Coding : (-1),(+1)
22 = 4 Runs
FACTORS INTERACTIONS
Runs tc A B AB
1 (1) -1 -1 +1
2 a +1 -1 -1
3 b -1 +1 -1
4 ab +1 +1 +1
8. Full Factorial Design Types
Three level Full FD
3 factors: X1, X 2and X3 3 levels : low(-1), intermediate (0), high (+1)
32= 8 Runs
FACTORS INTERACTIONS
Runs tc A B C AB AC BC ABC
1 (1) -1 -1 -1 +1 +1 +1 -1
2 a +1 -1 -1 -1 -1 +1 +1
3 b -1 +1 -1 -1 +1 -1 +1
4 ab +1 +1 -1 +1 -1 -1 -1
5 c -1 -1 +1 +1 -1 -1 +1
6 ac +1 -1 +1 -1 +1 -1 -1
7 bc -1 +1 +1 -1 -1 +1 -1
8 abc +1 +1 +1 +1 +1 +1 +1
9. Fraction Factorial Design Types
1. Homogenous fractional
Useful when large number of factors must be screened
2. Mixed level
Useful when variety of factors needed to be evaluated for main effects and higher level interactions
can be assumed to be negligible. Ex-objective is to generate a design for one variable, A, at 2
levels and another, X, at three levels , mixed &evaluated.
3. Box-Hunter
Fractional designs with factors of more than two levels can be specified as homogenous fractional
or mixed level fractional
10. Fraction Factorial Design Types
4. Plackett - Burman
Popular class of screening design. These designs are very efficient screening designs when only the
main effects are of interest. These are useful for detecting large main effects economically,
assuming all interactions are negligible when compared with important main effects. Used to
investigate n-1 variables in n experiments proposing experimental designs for more than seven
factors.
5. Taguchi
It is similar to PBDs. It allows estimation of main effects while minimizing variance.
Taguchi Method treats optimization problems in two categories,
STATIC PROBLEMS: Generally, a process to be optimized has several control factors which
directly decide the target or desired value of the output.
DYNAMIC PROBLEMS: If the product to be optimized has a signal input that directly decides
the output.
11. Advantages and Disadvantages of Factorial Design
Type Advantages Disadvantages
Full Factorial Design More efficient and
informative; more
robust and realistic;
more flexible and
adaptable
Costly; complex
analysis and
interpretation
Fraction Factorial
Design
More economical and
feasible
Complex and technical;
sensitive and
dependent on the
assumptions and
judgments of the
experimenter
12. Applications of Factorial Design
1. Formulation and processing
2. Clinical Chemistry
3. Medicinal chemistry
4. HPLC Analysis
5. Formulation of culture medium in virological studies
6. Study of pharmacokinetic parameters