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In calculus, the Product Rule provides a method for differentiating expressions that are the product of two functions. It states that the derivative of the product of two differentiable functions equals the first function times the rate of change of the second, plus the second function times the rate of change of the first.This rule ensures that the rate of change of the product accounts for the simultaneous variation of both functions.A compelling way to understand the Product Rule is through...
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Mechanistic models, a category encompassing both physiological and compartmental modeling, differ from empirical models' approaches to incorporating known factors about the systems being modeled. Empirical models describe data with minimal assumptions, while mechanistic models aim to provide a robust description of available data by specifying assumptions and integrating known factors about the system. Compartmental analysis is a key example of a mechanistic model in pharmacokinetics and...
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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Promoting Model-based Definition to Establish a Complete Product Definition.

Shawn P Ruemler1, Kyle E Zimmerman1, Nathan W Hartman1

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The manufacturing industry is shifting to 3D models for product data, known as Model-based Definition (MBD). While a Common Information Model wasn't established, survey insights will guide future investigations.

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Area of Science:

  • Manufacturing Engineering
  • Product Lifecycle Management
  • Data Management

Background:

  • The manufacturing industry is increasingly adopting 3D models for product data and definition, termed Model-based Definition (MBD).
  • This transition, part of the Model-based Enterprise (MBE) strategy, aims to replace traditional paper-based documentation.
  • Understanding information requirements for MBD is crucial for efficient product lifecycle processes.

Purpose of the Study:

  • To investigate the information needed for transitioning from drawings to 3D models in manufacturing.
  • To identify common data across different model stages to establish a Common Information Model (CIM).
  • To understand how 3D models are utilized in various industry workflows.

Main Methods:

  • A survey was administered to industry professionals across diverse sectors.
  • Data was collected on the use of 3D models and associated information within different workflows.
  • Analysis of survey responses to identify common data elements for CIM development.

Main Results:

  • A Common Information Model could not be established based on the survey results.
  • The survey provided valuable insights into industry practices and information needs for MBD.
  • Key data requirements for effective MBD implementation were highlighted.

Conclusions:

  • Further investigation is needed to establish a robust Common Information Model.
  • The findings offer a foundation for future research into MBD data standardization.
  • Industry insights are critical for advancing the Model-based Enterprise.