Candidate Selection & Intended Use
Discovery turns a target or an unmet need into a defined candidate: the intended use, the population it serves, feasibility, and the early characterisation that decides whether to continue. It is where the product first becomes a specific thing — and the intended use written at this point is inherited by classification, clinical design, labelling and the entire control strategy. Changing it later is not a document edit; it invalidates the reasoning built on top of it.
What an explainer is not
A topic explainer is SPEQ’s synthesis of what a practice involves, cited to the standards that govern it. It does not reproduce their text, and it does not determine which of them apply to your product or process.
[ POSITION IN THE FRAMEWORK ]
7 DIMENSIONS · 21 LINKSIntended use is the assumption every later study, specification and claim inherits — and because it is written when the least is known, it is the cheapest thing to get wrong and the most expensive to revisit.
06 · QUALITY MATURITY — CANDIDATE SELECTION & INTENDED USE, REACTIVE TO ADAPTIVE
A candidate advances because it worked in the assay. Intended use is described in a slide and never fixed.
A target profile exists, written at the start and not revisited, so the programme continues against assumptions the data has already moved.
Intended use is stated precisely enough to derive requirements from, and the profile is updated as evidence arrives rather than defended.
Selection criteria include what the product would have to be manufacturable and administrable as, so a candidate that cannot be made is stopped early.
The organisation kills candidates on the evidence rather than on the calendar, and the target profile is the document decisions are actually made against.
SPEQ’s shared five-stage progression, labelled synthesis — not the FDA QMM rating scale. Where does your organization sit? Score your quality system →
07 · REGULATORY & EVIDENCE
GOVERNING STANDARDS · 4
Derived from the 4 standards SPEQ maps to this subject, across 2 regulatory bodies: ICH, ISO.
RECORDS & OBJECTIVE EVIDENCE
- The target product profile, with its version history
- Selection criteria and the decision record at each stage gate
- Nonclinical evidence supporting the intended use as stated
- Manufacturability and formulation feasibility assessments feeding selection
- Records of candidates stopped, and the evidence that stopped them
COMMON INSPECTION FINDINGS
- An intended use so broad that no requirement can be derived from it
- A target profile unchanged through years of evidence that contradicted it
- Selection made on efficacy alone, with manufacturability discovered later
- Stage gates passed with no recorded decision or criteria
- Claims later pursued that the intended use never contemplated
Intended use is a regulatory instrument, not a marketing sentence
The intended-use statement determines what the product legally is, which regulator reviews it, what evidence it must generate, and what may later be claimed for it. A device intended to aid diagnosis and one intended to make a diagnosis are different products under the same hardware, with different risk classifications and different clinical-evidence obligations.
It is usually drafted early by people focused on the science, in language chosen for a scientific audience, and then inherited unexamined. The discipline worth imposing is to write it as though a regulator will read it as a claim — because that is what happens — and to have the person who will own the submission read it while it can still be changed cheaply.
Target product profile as the forcing document
A target product profile states, in advance, what the finished product must achieve: the population, the indication, the route and dosage form, the efficacy and safety bar, and the competitive position it must reach to be worth developing. Its function is to make the development programme answerable to a specification rather than to accumulated momentum.
The value shows up at decision points. Without a target profile, a candidate that is merely proceeding is indistinguishable from one that is succeeding, because there is no stated standard it is failing to meet. Programmes are terminated late for exactly this reason far more often than they are terminated for a surprising result.
Early risk work that is worth doing at this stage
ICH Q8 places the quality target product profile at the start of pharmaceutical development, from which critical quality attributes are derived. ISO 14971 does the equivalent for devices, and its first step is intended use and reasonably foreseeable misuse — which is a statement about people, made before any design exists.
The point of doing this early is not documentation completeness. It is that a hazard identified at concept can be designed out for nothing, while the same hazard identified after design freeze becomes a control that manufacturing operates for the product’s whole commercial life. The cost asymmetry between those two moments is the largest in the development lifecycle.
SPEQ interpretation — feasibility should include the control burden
Candidate selection weighs efficacy, safety, developability and commercial potential. It rarely weighs what the candidate will cost to control: a molecule requiring containment, a formulation needing cold chain, a device architecture demanding a sterile barrier, a process whose critical parameters are narrow enough to make routine manufacture marginal.
Each of those is knowable at selection and becomes a permanent operating commitment. Putting the anticipated control burden into the selection criteria — not as a veto, but as a stated cost alongside the others — is a small change to a decision paper that determines what operations will be living with for fifteen years.
FREQUENTLY ASKED
Why does the intended-use statement matter so much this early?
Because it determines the product’s legal classification, the regulator that reviews it, the evidence it must generate, and what may later be claimed. A device intended to aid diagnosis and one intended to make a diagnosis are different products with different risk classes and evidence obligations, on identical hardware.
What is a target product profile for?
To make the development programme answerable to a stated specification rather than to momentum. Without one, a candidate that is merely proceeding looks the same as one that is succeeding, because nothing has been written down that it is failing to meet — which is why programmes are terminated late far more often than they are terminated for a surprising result.
Why do early risk assessments matter more than later ones?
Cost asymmetry. A hazard identified at concept can be designed out for almost nothing; the same hazard found after design freeze becomes a control that manufacturing operates for the product’s entire commercial life. It is the largest cost gap anywhere in the development lifecycle.
What is usually left out of candidate selection criteria?
The control burden. Containment requirements, cold-chain dependency, a sterile barrier, or critical parameters narrow enough to make routine manufacture marginal are all knowable at selection and all become permanent operating commitments. They belong in the decision paper as a stated cost alongside efficacy and commercial potential.