The dossier and its documents

An application to market a medicine carries its evidence in a dossier, assembled in the Common Technical Document's modules, and the writing for it produces the dossier's documents and the product information drawn from them. This branch covers that dossier, and its parts divide by the document or part of the dossier being written: the format as a whole and its overviews, the quality module and the pharmacopoeial standards it draws on, the nonclinical documentation, the bioanalytical, modelling and integrated summary documents that carry clinical pharmacology and pooled evidence, the justifications filed beside them for a biowaiver, the environmental risk assessment and the F value, and the product information and packaging text. It leaves the application and the procedures it runs through to applications and authorisation procedures, clinical study reports to their own branch under clinical trials, and the risk management plan to risk management under pharmacovigilance.

• The Common Technical Document — the five modules and what each holds, the summaries and how long each Module 2 document runs, what an overview is for and how to plan and write one, the clinical overview above all, the conventions for presenting the dossier, its electronic form, the regions that depart from it, and the separate dossiers it replaced
• Quality documentation in the CTD — what Module 3 holds on the active substance and the drug product: manufacture, pharmaceutical development, excipients, specifications, analytical procedures, impurities, reference standards, container closure and stability, how much detail an application commits the sponsor to, and country-specific dossiers built from one master dossier
• Compendial standards and the pharmacopoeias — what a compendium is, the USP–NF, the place of compendial standards in US law, what compendial tests are used for, compendial science, and what medical writers know about the compendia
• Nonclinical documentation in the CTD — the documents that carry nonclinical content, the Module 2 overview and summaries and the Module 4 study reports, SEND data, planning back from the modules to the source documents and their state, what the overview and its subsections assess, nonclinical results in the label, the written and tabulated summaries, the FDA's review, and condensing and consistency
• Bioanalytical reports — what depends on measured concentrations and the writer's contribution, accuracy, precision, incurred sample reanalysis and the validated range, the guidelines and regulations that apply, the method validation report and the analytical report section by section, and bioanalysis in the Common Technical Document
• Modelling and simulation reports — what pharmacometric models are for, modelling in regulatory guidance, the requirements on the report, the path from data to submission, generating the report from the analysis code with its advantages and drawbacks, modelling in rare-disease dossiers, and writing about modelling
• Biowaivers — when in vitro evidence can replace an in vivo bioequivalence study: additional strengths, dosage forms that need no equivalence data, the Biopharmaceutics Classification System, and documenting the waiver
• Integrated summaries of safety and efficacy — the levels of clinical summary in the dossier, pooled and study-by-study presentation, the data and statistical strategies for pooling, choosing the studies, endpoints and time points, analysing the pool without Simpson's paradox, writing the summaries as a team, the writers' tasks on each summary document, and oncology programmes
• Environmental risk assessment for human medicines — the EU obligation and its legal basis, the phased assessment of a medicine that is not a genetically modified organism and the separate assessment of one that is, Module 1.6 and the structure of the assessment, labelling and risk mitigation, evaluation questions and updates after authorisation, the assessment's shortcomings, and the medical writer's contribution
• Child-resistant packaging and the F value report — the number of dose units that can seriously harm a small child, how it is set from the evidence available, often without data from children, worked calculations, and preparing the report that justifies it
• Product information and packaging text — the summary of product characteristics and prescribing information, the package leaflet and patient insert, the labelling and packaging text, and electronic product information