Expertise & Capabilities

During a recent What’s New in JMP 18 seminar, the customers kept asking about other new JMP features. These other new features were new, but they were new in JMP 17! JMP updates software so frequently, many customers don’t have time to learn new features of one version before the next version is out. This complementary seminar will benefit those customers that are still using JMP 17 as well as those that have updated to JMP 18.

Thursday August 1, 2024 from 1:00 – 3:00 Eastern Time

Comparability for Chemistry, Manufacturing, and Controls (CMC) in the Pharmaceutical Industry (1.0 days in two, half-day sessions): The FDA comparability guidance (1996) recognizes the need for manufacturers to improve manufacturing processes and analytical procedures without performing additional clinical studies to demonstrate product safety and efficacy. This guidance was extended in ICH Q5E (2004) to provide additional direction for comparing pre- and post-change manufacturing processes. From that time, both the FDA and EMA (and USP) has issued guidance documents, papers, and presentations outlining the need for comparability studies.

Across the regulatory documents, there are only high-level recommendations for the design of an equivalence/comparability study and for setting acceptance criteria to assess the impact of the change. With few exceptions, these documents do not generally contain prescriptive rules for setting acceptance criteria, study design, or statistical procedures for analysis.  This course presents statistical approaches for demonstrating comparability consistent with these regulatory guidelines. In addition, this course provides JMP scripts for power and sample size determinations as well as appropriate constants for intervals used to calculate quality ranges:

• Explanation of differences between statistical methods used for demonstrating comparability and when each is appropriate.
• A list of considerations for selecting an appropriate
• An approach for setting comparability
• A method to determine reasonable sample sizes

Examples provided in the course include: qualification of reference standards, comparison of manufacturing sites, split-apheresis in gene and cell therapies, analytical bridging studies, tech and analytical transfer, scale-down model (SDM) qualification, analytical similarity of biosimilars, and accelerated stability studies.

Methods discussed in the course include: side-by-side plots, statistical equivalence tests for means and average slopes (TOST), non-inferiority of standard deviations, and quality ranges (min-max intervals, tolerance intervals, 3-sigma intervals, and risk-based side-by-side intervals) for individual data values and individual slopes (accelerated stability studies).

Outline:
1. Comparability Studies
• Comparability Basics and Definitions
• Comparability Tools and Statistical Designs
• CMC Applications

2. Comparability Tools
• Considerations in Selecting an Approach
• Statistical Tests
• Quality Ranges
• Comparison of Methods

3. Defining Acceptance Criteria and Power Calculations
• Power and Statistical Power Calculations
• Other Guidance and Recommendations

4. Analytical Method Case Studies (Optional)
• Reference Standard Qualification
• Analytical Method Transfer
• Method Bridging Study

5. Process Case Studies (Optional)
• Scale Down Model (SDM) Qualification
• Gene and Cell Therapies
• Biosimilar Case Study

6. Comparability in Accelerated Stability Studies
• Considerations for Accelerated Stability Studies
• Equivalence Testing and Quality Range Approaches