32: Direct effect PKPD models (Ep. 32)
In this episode I describe direct effect PK-PD models. I describe how they work, a method of creating exploratory plots to identify direct effect models, how to set up...
31: What should you use to present PK results? (Ep. 31)
In this episode I discuss different methods of presenting pharmacokinetic and pharmacometrics results. I spoke about using PowerPoint and R Markdown derived HTML files. While I prefer HTML files...
30: How important is terminal rate constant? (Ep. 30)
This episode covers the terminal elimination rate constant calculated using non-compartmental analysis techniques. I reviewed how the rate constant is used to estimate half-life and extrapolate AUC to infinity,...
29: Parellelization in modeling (Ep. 29)
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...
28: Residual errors and submission packages (Ep. 28)
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...
27: Simulations (Ep. 27)
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...
26: Different work environments (Ep. 26)
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...
25: Biosimilar products (Ep. 25)
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...
24: Choosing an absorption model (Ep. 24)
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,...
23: What is Aplos NCA? (Ep. 23)
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...
22: Big announcement and Hepatic impairment studies (Ep. 22)
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...
21: Project Optimus (Ep. 21)
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...
20: Tackling TMDD Models (Ep. 20)
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...
19: Communication for scientists (Ep. 19)
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,...
18: Cell Therapy and Clinical Pharmacology (Ep. 18)
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...
17: Allometry in Pediatrics and First in Human Studies (Ep. 17)
Happy New Year! Today’s episode is all about allometric scaling in pharmacokinetic and pharmacodynamics. In particular, I’ll discuss how to use it for scaling from adults to pediatrics and...
16: Computer System Validation for Pharmacometrics (Ep. 16)
This is the last podcast for 2023. Thank you for listening throughout the year! In today’s episode I talk about computer system validation for pharmacometrics. I review my experience...
15: QSP, PBPK, PKPD, PopPK … analysis abbreviation soup! (Ep. 15)
In today’s episode I cover 4 different modeling approaches: QSP, PBPK, PopPK, and PKPD. All of these are methods for analyzing data to predict either drug concentrations, or a...
14: Clinical Drug Interaction Studies (Ep. 14)
In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the guidance. Then I will review recommendations for...
13: Handling BLQ samples (Ep. 13)
In today’s episode I discuss BLQ handing for both non-compartmental and modeling analysis approaches. I discuss how BLQ samples are defined, methods for analyzing them, and situations when you...
12: PK in patients with impaired renal function (Ep. 12)
In today’s episode I discuss the evaluation of pharmacokinetics in patients with impaired renal function. I include information from both the US FDA and EMA guidance documents linked below....
11: Model diagnostics and selection (Ep. 11)
This episode is a discussion on model evaluation and selection. I discussed diagnostic plots using predictions and residuals. I covered approaches for model selection and factors to consider. The...
10: Exposure-Response FDA Guidance (Ep. 10)
This episode is a discussion of the FDA guidance “Exposure-Response Relationships”. The relationship between drug exposure and response is critical to any determination of the safety and effectiveness of...
9: Finding a job in Clinical Pharmacology (Ep. 9)
This episode I talk about finding a job in Clinical Pharmacology or Pharmacometrics. I share a few thoughts from my experience followed by an interview with TJ Elder, the...
QT Prolongation Guidance ICH E14 (Ep. 8)
This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”. I start with background...
Pediatric Extrapolation (Ep. 7)
Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Kushal and Parmesh. In this episode, I discuss a general...
6: Bioequivalence Guidances from FDA and EMA (Ep. 6)
Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Drew. In this episode, I discuss bioequivalence studies and generic...
5: Nuances of NCA (Ep. 5)
In this episode, I discuss some nuances of non-compartmental analysis or NCA. I am going to focus on three separate parameters: Cmax, AUC, and the terminal elimination rate constant....
4: Population PK FDA guidance (Ep. 4)
In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission requirements for population PK models. Links...
3: Comparing NCA and PK models (Ep. 3)
In this episode, I discuss two data analysis techniques: (1) non-compartmental analysis or NCA, and (2) PK modeling. I discuss the basic premise of each method and similarities and...
2: Food Effect FDA Guidance (Ep 2)
In this episode, I discuss the 2022 FDA guidance on food effect studies. I discuss the timing of these studies in your development programs, various aspects of study design,...
1: Podcast about clinical pharmacology (Ep 1)
In my inaugural episode, I introduce myself, describe the type of clinical pharmacology and pharmacometrics content I will share, let you know how to get in touch with me,...