References for Pharmacometrics Modeling Skills
What to read, in what order, and what has actually been checked
Nothing below has been read or checked. The queue was written from memory on 2026-10-02 as a starting list. Authors, years and journals need confirming before any entry is cited in a skill.
The working document is the specification, and the folder’s other documents are on the project index.
Status markers
- ❌ Not checked. The entry has not been read, and its description here comes from memory or a search result.
- ⚠️ Transcribed, unverified. A checklist item or recommendation in a skill came from this source but has not been checked against it.
- ✅ Checked. Verified against the source.
On a reading-queue entry, ✅ means the question under the entry has been answered, by reading the source or by deciding it is out of scope. Change a marker when the check is done, not when the source is opened.
Reading queue
The question under every entry is the same: which checks or recommendations does this source give, and which topic in Section 3 of the specification do they belong to?
1. Byon et al. 2013 — an internal population PK analysis guidance ❌
CPT: Pharmacometrics & Systems Pharmacology. A company’s account of writing and using an internal guidance for population modeling. The closest published precedent for this project; read first.
2. FDA 2022 — Population Pharmacokinetics, guidance for industry ❌
What the agency expects of a population PK analysis: data, model development, evaluation and reporting.
3. EMA 2007 — Guideline on reporting the results of population pharmacokinetic analyses ❌
The European counterpart, on reporting.
4. ICH M15 — General principles for model-informed drug development ❌
Model risk, model credibility and the documentation a model analysis owes. Check the status of the guideline before citing it.
5. Dykstra et al. 2015 — reporting guidelines for population PK analyses ❌
Journal of Pharmacokinetics and Pharmacodynamics. A reporting checklist written by modelers.
6. Nguyen et al. 2017 — model evaluation of continuous data pharmacometric models ❌
CPT: Pharmacometrics & Systems Pharmacology. The metrics and graphics for evaluating a model, with what each one can and cannot show. The likely backbone of a model evaluation skill.
7. Mould and Upton 2012 and 2013, Upton and Mould 2014 — population modeling tutorials ❌
CPT: Pharmacometrics & Systems Pharmacology, three parts: basic concepts, model building and evaluation, covariate modeling.
8. Bergstrand et al. 2011 — prediction-corrected visual predictive checks ❌
The AAPS Journal. The standard form of the visual predictive check where dose or covariates differ across subjects.