The Pathfinder #4a - Reimaging Regulatory Pathways: Exploring AI, Modified-Release Dosage Forms, and Quality Management Strategies
The Pathfinder
This week's newsletter covers three topics in the pharmaceutical industry. Volume 1 discusses the critical decisions and considerations required for developing modified-release versions of immediate-release oral solid dosage forms while meeting regulatory requirements. Volume 2 provides a guide for managing and reporting quality-related issues, adverse events, product complaints, and product recalls to ensure patient safety and comply with regulatory requirements. Volume 3 explores the use of AI and IA in drug development to streamline the regulatory CMC process and improve collaboration between organizations and regulatory authorities. The newsletter emphasizes the importance of understanding specific regulatory requirements and selecting the right tools and team to harness the power of AI for drug development. Please share as you see fit!
Developing modified-release versions of immediate-release oral solid dosage forms involves critical strategic decisions and considerations for regulatory CMC. The development team must choose an appropriate modified-release mechanism and establish the optimal release profile while understanding regulatory requirements. Active Pharmaceutical Ingredient (API) characterization and pre-formulation work provide essential information, improve process understanding, and support regulatory submissions. Health authorities expect critical CMC development data, including formulation development, manufacturing process, analytical method development and validation, stability data, in-vitro release studies, biopharmaceutical classification system (BCS) and biowaiver, clinical development plan and data, and comparative data. These data are needed to demonstrate that the modified release product is suitable for its intended use and of suitable quality for regulatory approval.
The article discusses a guide for managing and reporting quality-related issues, adverse events, product complaints, and product recalls in the pharmaceutical industry. It explains the different types of issues that can occur at various stages of the manufacturing process and provides steps for handling and reporting these issues. The article emphasizes the importance of proper documentation and reporting to regulatory agencies to ensure patient safety and comply with regulatory requirements. It also highlights the need to consult with regulatory agencies to understand their specific requirements for handling and reporting these issues.
The use of Artificial Intelligence (AI) and Augmented Intelligence (IA) in drug development can streamline the regulatory process for Chemical, Manufacturing, and Control (CMC) strategies and submissions. AI-based methods, such as predictive analytics and machine learning, can help monitor decision-making regarding quality control and reduce costs associated with corrective action plans. AI can also automate certain aspects of the regulatory CMC process, such as generating CMC documents, and increase collaboration between organizations and regulatory authorities. By understanding the specific goals and objectives of the drug development process, selecting the right AI-powered tools, and having the right team in place, organizations can harness the power of AI to improve the regulatory CMC process.
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What is The PathFinder?
The PathFinder is a Regulatory intelligence newsletter publication that provides Lifesciences organizations with up-to-date information on current and upcoming regulations. The PathFinder focuses on relevant topics such as regulatory developments, compliance trends, legal updates, enforcement actions, industry insights, and best practices. Articles are written by experts in the field to ensure accuracy and help sponsor companies stay informed about changes in their regulatory environment.
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Introducing ENKRISI – the leading consulting group helping organizations comply with drug regulations through a comprehensive drug development model incorporating augmented intelligence (AI) and data analytics. Our team of industry experts is equipped to help both emerging biotechs and established pharmaceuticals understand how to use AI and machine learning to stay on top of rapidly changing regulatory requirements. We're here to help navigate the complex world of compliance more manageable than ever!