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1. GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY TOPIC: STATISTICAL DESIGNING OF EXPERIMENTS NAME OF THE STUDENT: KOUSHIK PAUL UNIVERSITY ROLL NUMBER: 18601919115 ACADEMIC SESSION: 2022-2023 PAPER NAME: BIOSTATISTICS AND RESEARCH METHODOLOGY PAPER CODE: PT 817 Maulana Abul Kalam Azad University of Technology

2. INTRODUCTION [1,2] B. PHARM./ SEM 8 /2022-23/BIOSTATISTICS AND RESEARCH METHODOLOGY / PT 817/Presentation_2 2 Design of experiments (DoE) is a branch of applied statistics that is used for conducting scientific studies of a system or process in which input variables (X1, X2, X3, ...) are manipulated to investigate its effects on measured response variable (y1 y2 y3, ...). WHY WE USE DoE? Reduce time to design/develop new products & processes Improve performance of existing processes Improve reliability and performance of products Achieve product & process robustness Perform evaluation of materials, design alternatives, setting component & system tolerances Figure 01: Example of DoE, diagram of a cake-baking process What is an experiment? An experiment refers to any process that generates a set of data. An experiment involves a test or series of test in which purposeful changes are made to the input variables of a process or system so that changes in the output responses can be observed and identified.

3. FACTORS, LEVELS, RESPONSE [1,2,3] 3 B. PHARM./ SEM 8 /2022-23/BIOSTATISTICS AND RESEARCH METHODOLOGY / PT 817/Presentation_2 FACTORS: Factors are inputs to the process Factors can be classified as either controllable or uncontrollable variables. In this case, the controllable factors are Flour, Eggs, Sugar and Oven. Potential factors can be categorized using the Cause & Effect Diagram LEVELS: Levels represent settings of each factor in the study Examples include the oven temperature setting, no. of spoons of sugar, no. of cups of flour, and no. of eggs RESPONSE: Response is output of the experiment In the case of cake baking, the taste, consistency, and appearance of the cake are measurable outcomes potentially influenced by the factors and their respective levels. BASIC STEPS IN DoE: Four elements associated with DoE: The design of the experiment, The collection of the data, The statistical analysis of the data, and The conclusions reached and recommendations made as a result of experiment. SOFTWARE USED IN DoE: Minitab SPSS (Statistical package for social sciences) SAS (Statistical analysis system) Design expert FACTOP OPTIMA XTAP OMEGA Prisma

4. DRUG DELIVERY OPTIMIZATION: DoE METHODOLOGY [1,2,3] 4 B. PHARM./ SEM 8 /2022-23/BIOSTATISTICS AND RESEARCH METHODOLOGY / PT 817/Presentation_2 Figure 02: Seven-step ladder for optimizing drug delivery systems.

5. APPLICATIONS OF DoE [1,2,3] 5 B. PHARM./ SEM 8 /2022-23/BIOSTATISTICS AND RESEARCH METHODOLOGY / PT 817/Presentation_2 Manufacturing and engineering: DoE can be used to optimize the performance of manufacturing processes and improve the design of engineering systems. This can lead to increased efficiency, reduced costs, and improved product quality. Scientific research: DoE can be used in scientific research to study the effects of different factors on a particular phenomenon. This can include studying the effects of different treatments on a disease, or the effects of different environmental factors on a species. Quality control: DoE can be used in quality control to identify and eliminate sources of variability in a process. This can lead to improved product quality and reduced costs. Medical research: DoE can be used in medical research to study the effects of different treatments or therapies on a disease. This can include studying the effects of different medications or the effects of different surgical procedures. Agriculture and food processing: DoE can be used in agriculture and food processing to optimize the performance of crop production and food processing operations. This can lead to increased yields, improved product quality, and reduced costs. Pharmaceutical industry: DoE can be used in the pharmaceutical industry to optimize the performance of drug synthesis and formulation; this can lead to improved product quality and reduced costs. Environmental engineering: DoE can be used in environmental engineering to optimize the performance of processes that treat water and air pollutants. Energy Industry: DoE can be used in the energy industry to optimize the performance of renewable energy systems and improve energy efficiency. Consumer goods: DoE can be used in the consumer goods industry to optimize the performance of products such as cosmetics, cleaning products and food. Service Industry: DoE can be used in the service industry to optimize the performance of service processes such as customer service, delivery, and logistics.

6. SUMMARY 6 B. PHARM./ SEM 8 /2022-23/BIOSTATISTICS AND RESEARCH METHODOLOGY / PT 817/Presentation_2 Today, DoE software is most valuable tool for engineers, scientists, biologists and new drug developers. Computer software's are available designing of experiments from various software companies, and it includes packages such as JMP, Minitab, Design-Expert, Statistical, SPASS, SAS, stat graphics, R, Microsoft Excel, etc. Minitab and statistica are most popular packages that are equipped with user friendly interfaces and very good graphics output. Microsoft excel is also commonly used software for DoE design and analysis. DoE software's are the fastest and most cost-effective way to design different experiments, increase productivity and face challenges in new drug development.

7. REFERENCE 7 B. PHARM./ SEM 8 /2022-23/BIOSTATISTICS AND RESEARCH METHODOLOGY / PT 817/Presentation_2 Singh, B., R. Kumar, and N. Ahuja, (2005). Optimizing drug delivery systems using systematic "design of experiments." Part I: fundamental aspects. Crit Rev Ther Drug Carrier Syst, 22(1): p. 27-105. Kothari, C.R., (1990). Research Methodology Methods and Techniques (Second Revised Edition). New Age International Publishers: Research Design, (pp. 31-52). Fisher, R.A. (Paperback, 1990). Statistical Methods, Experimental Design, and Scientific Inference: A Re-issue of Statistical Methods for Research Workers, the Design of Experi - ments , and Statistical Methods and Scientific Inference. Oxford University Press.