This episode covered parallelization in modeling analyses. I spoke about across model parallelization and within model parallelization. I recommended some approaches for choosing how many cores to use in parallelization and also discussed different modeling computer systems you can use.

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Today I covered 2 different topics. First, I spoke about residual error models when modeling. I discussed additive, proportional, and power models. I also reviewed combined models and when they can be helpful. Then I spoke about modeling report submission packages. I explained what I put in those packages, how they are used, and some potential changes coming in the future.

Links discussed in the show:

• Publication on model master file
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This episode discusses simulations. I group simulations into 4 categories: (1) average response, (2) population, (3) individual, and (4) clinical trial simulations. I discuss details of each of these types of simulations and the different variability terms included in each one. I strongly recommend that we implement more clinical trial simulations in our work. This will help us design and execute more successful clinical trials that take advantage of our existing knowledge about a drug. Enjoy the show and connect with me using the links below if you have any questions.

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Today’s show is about different work environments and not scientific topics. Throughout my career I have worked in many different types of companies, and I would like to share some observations with you from those experiences. I have held positions at startup companies or small biotechnology companies, large pharmaceutical companies, contract research laboratories, consulting firms, and working for myself as a consultant, and now as a software developer. Although my work has been focused on clinical pharmacology and pharmacometrics, the jobs and work environments are very different.

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Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of interchangeability between the biosimilar and reference products.

Links discussed in the show:

• FDA Guidance on Clinical Pharmacology Data to support Biosimilarity (May 2016)
• FDA Guidance on Demonstrating Interchangeability (May 2019)
• FDA Q&A on Biosimilarity and Interchangeability (Sep 2023)
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Today’s show discussed approaches for modeling absorption profiles. I discussed the rationale behind modeling absorption and then described some common models. These included first-order absorption, zero-order absorption, transit compartments, distributed delay, Weibull, and zero/first order absorption. I also provided my recommendations on how to model absorption.

Links discussed in the show:

• Distributed delay modeling in PK and PD
• Modeling biphasic formulation of methylphenidate
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Today’s show was an overview of Aplos Analytics and the development story for Aplos NCA. Please consider participating in the Early Access Program. Use the link below to learn more about Aplos NCA.

Links discussed in the show:

• Aplos Analytics website
• Aplos Analytics Contact Us Page
• You can connect with me on LinkedIn and send me a message
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Today’s show is about hepatic impairment clinical studies. I cover the rationale behind evaluating hepatic impairment, common study designs, and key factors in the analysis and interpretation of the study results. I also share a huge announcement about Aplos NCA, a cloud-based solution for calculating NCA PK parameters. Use the link below to learn more about Aplos NCA.

Links discussed in the show:

• FDA guidance
• EMA guideline
• Aplos Analytics website
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter

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