The design of experiments (DOE, DOX, or experimental design) is the design of any task that aims to describe and explain the variation of information under conditions that are hypothesized to reflect the variation. The term is generally associated with experiments in which the design introduces conditions that directly affect the variation, but may also refer to the design of quasi-experiments, in which natural conditions that influence the variation are selected for observation.
its simplest form, an experiment aims at predicting the outcome by introducing a change of the preconditions, which is represented by one or more independent variables, also referred to as "input variables" or "predictor variables." The change in one or more independent variables is generally hypothesized to result in a change in one or more dependent variables, also referred to as "output variables" or "response variables." The experimental design may also identify control variables that must be held constant to prevent external factors from affecting the results. Experimental design involves not only the selection of suitable independent, dependent, and control variables, but planning the delivery of the experiment under statistically optimal conditions given the constraints of available resources.
Design of Experiment (DoE), an integral chemometric tool for process optimization, has lately been applied to various research areas. Recent literature reports indicate a significant surge in the applications of DoE principles in phytopharmaceutical sector. DoE approach is followed and accepted worldwide in nutraceutical and phytochemical industries for economical and efficient extraction of bioactive principles from various plant materials. Such approaches not only help economical extraction, but also do conjointly facilitate unearthing and better understanding of scientific trivialities among the critical material attributes, critical process parameters, and product quality attributes in order to manage and control the potential sources of deviation in an extraction process development.
How does the Regulated Industry like Pharmaceutical and Biotechnology & Medical Devices & Automotive industries move forward to achieve the expected changes in the Regulatory agencies?
The answer lies in applying the principles of Quality by Design (QbD) into product and process design phases (e.g., ICHQ8, ICHQ9) and establishing quality systems (e.g., ICHQ10) that support QbD.
What is the simplest tool to be used to apply QbD into Product and Process design phases?
The Answer is 'SIGMA TECH' software. Yes, fully integrated and 21 CFR part 11 Complaint software will help you to apply and achieve QbD principles and benefits to your organization. The data generated through this software can be most useful in compiling your regulatory filing (DMF, ANDA and NDA) for product /market approval.
What Sigma Tech software package can do for you?
It helps in Contract Research Work to reduce time cycle appreciably
while accomplishing the objectives.
It enables to develop robust processes/ Products.
Helps in Process Validation.
Six Sigma compliance process design.
Capable of “fine tuning" a process to consistently hit a target.
Screens cost effective alternative materials, Solvents & Catalysts.
Identifies the CPPs affecting a process consistency and CQAS that affect the product Quality enabling to define Design Space.
Balances multiple output characteristics to achieve desirable outcomes.
Significantly reduces the rejections to improve the bottom line of an organization.
Builds the quality in to the process at the stage of developing a process.
