Packages/Submission package
NDA · BLA · MAA

Make the dossier's MIDD evidence review-ready

Scope this package
Delivery
Up to 6 weeks from a clean dataset
Price
Fixed, quoted after the call
Typical model risk
Rated per analysis

What is at stake

At filing, every modeling result will be read, and often rerun, by the agency. Inconsistent reports, missing datasets or code that does not run lead to information requests in the middle of review.

Question of interest

Is the MIDD evidence in the dossier complete, consistent and ready for review?

The package assembles the final population PK, exposure-response and other MIDD analyses for the marketing application. Each analysis keeps its own question of interest, context of use and assessment table.

What reviewers will ask

Can the results be reproduced from the submitted code and data?

Every reported number is regenerated by independent re-execution before submission.

Are covariate-based dose recommendations justified?

They appear only where the covariate effect matters clinically, judged against the exposure-response.

Are the analyses consistent across documents?

Reports, Module 2.7.2 and the label text are generated from the same outputs.

What you receive

  • Population PK and exposure-response reports for Module 5.3.3.5
  • ADPPK datasets, define.xml and reviewer guide
  • Code as plain text, with run logs
  • Module 2.7.2 sections and clinical pharmacology labelling text
  • Responses to information requests on our analyses

What we need from you

  • Final locked datasets from the pivotal and supporting studies
  • Previous MIDD reports and models, if any were done elsewhere
  • The submission timeline and the publishing team's specifications
MAR · PMX-101 PopPKContents
  1. 1Question of interest and context of use4
  2. 2M15 assessment table6
  3. 3Data and data handling8
  4. 4Methods14
  5. 5Results22
  6. 6Model evaluation31
  7. 7Simulations38
  8. 8Limitations44
  9. 9Verification summary47
  10. ARun log, code and dataset index50
Scientific approach

Analyses. Final population PK with the full covariate assessment, and exposure-response for efficacy and safety, built on the analysis plans agreed earlier in the program where they exist.

Covariates and labelling. Forest plots of covariate effects on exposure against a reference range, translated into dose-adjustment language only where the evidence supports it.

Standards. Datasets to CDISC ADaM conventions for ADPPK, with define.xml and reviewer guide. Code and outputs traceable from the report to the run log.

Review readiness. Every number in the report regenerated from delivered code by an independent re-execution before submission.

Relevant guidance: FDA and EMA population PK guidance; FDA exposure-response guidance; FDA study data technical conformance guide; ICH M4 (CTD); ICH M15.

Is this the decision in front of you?

Fixed price, paid in two milestones. A guaranteed date. Agency questions on this analysis answered at no extra cost. Pricing · How we work

Scope this package