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…

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,…

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…

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…

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…

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…

Today’s episode was about Project Optimus, the FDA initiative to improve dose selection and optimization for oncology products. Julie Bullock was a guest on this episode and shared her expertise as a former oncology clinical pharmacology reviewer at the FDA and as a current consultant in the pharmaceutical industry. Links discussed in the show: Project…

Today’s show is about TMDD or target-mediated drug disposition models. I review the scientific and physiologic basis for TMDD models, how to review data and determine if a TMDD model is needed. I review the various modeling approaches along with my recommendations for specific TMDD models. I hope this information helps you understand how to…

Today’s episode is about communication for scientists. I believe that improvements in communication skills can have a greater impact on your career and work than technical skills. Michael Piperno, an expert in communication and leadership skills joins me to discuss communication challenges and solutions for clinical pharmacologists and pharmacometricians. Links discussed in the show: You…

Today’s episode is about cell therapies, including CAR T-cell theraphy for cancer. I give an overview of cell therapy and the challenges of clinical pharmacology in this new area of research. Links discussed in the show: CAR T-cell Therapy Image You can connect with me on LinkedIn and send me a message Send me a…