ISO/TR 12417-2:2017 心臓血管インプラントと体外システム—血管デバイスと薬剤の組み合わせ製品—パート2：地域の規制情報 | ページ 6

3.1

active pharmaceutical ingredient

API

drug substance

pharmacologically active (drug or medicinal) substance used as a raw material, which is coated on, bound to or incorporated into the device to achieve an ancillary device function, such as minimizing vascular restenosis

3.2

batch

quantity of VDDCP at the final stage or pre-final stage of manufacture which is manufactured according to a single manufacturing order and has undergone the same manufacturing cycle, using the same components (e.g. same coating solution, same device size), and meets the same specifications

Note 1 to entry: Validation testing can be conducted to demonstrate that manufacturing variables do not impact specifications such as drug content or drug release, and thereby permit such manufacturing variables within a batch.

3.3

change

alteration to an activity to improve or maintain the composition or performance of a VDDCP

Note 1 to entry: This include small alterations to a VDDCP, a manufacturing process, or a test procedure, even if it is not necessarily captured by a Corrective Action/Preventative Action (CAPA) system, and may require reporting to local regional authorities

3.4

clinical event

complication, failure or device-related observation that might be observed with clinical use of a VDDCP

Note 1 to entry: Such events might not have clinical significance and might not be attributable to the VDDCP.

3.5

critical component

component whose specifications, if not met, could result in unacceptable risk to the patient, clinician or others, or could have a significant impact on performance

3.6

device part of the VDDCP

DP

part of the VDDCP intended to treat vascular disease by temporary or long-term intervention or implantation that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but might be assisted in its function by such means

3.7

drug product

medicinal product

active pharmaceutical ingredient, in its final formulation for administration to the patient (e.g. tablet, solution, spray), that is intended to prevent, diagnose, or treat disease and that achieves its principle intended action in or on the human body by pharmacological, immunological, or metabolic means

3.8

drug-containing part of the VDDCP

DCP

part of the VDDCP that consists of the active pharmaceutical ingredient or matrix and associated device interfaces intended to assist in the primary mode of action of the device and/or diminish or ameliorate an unintended effect that placement of the device part might stimulate

Note 1 to entry: Some VDDCPs have medicinal substance(s) bound with the primary intent to optimize the surface properties of the device.

3.9

DCP interface

common boundary or interconnection between the various components of the device part(s) and the drug-containing part(s) of a VDDCP

3.10

drug content

total labelled amount of active pharmaceutical ingredient in a VDDCP

Note 1 to entry: Drug content could be expressed as µg/DCP of a certain size.

3.11

drug delivery

local interaction between the VDDCP drug and the in vivo environment, whether the drug is released from, eluted from or remains bound to the VDDCP

3.12

drug release profile

in vitro characterization of the active pharmaceutical ingredient released from the DCP of a VDDCP over time

Note 1 to entry: For example, the drug release might be characterized by a drug elution test, and could include a curve shape (or profile), a drug release rate, or both.

3.13

efficacy

ability of the VDDCP to achieve the planned and desired physiological result

3.14

evaluate

appraise or analyse qualitatively

3.15

excipient

additional material, other than the API, that are intentional components of the drug-containing part of a VDDCP

3.16

functionality

ability of the VDDCP to perform physically, chemically and/or mechanically, as designed

Note 1 to entry: Functionality does not include the physiological response to the VDDCP (i.e. efficacy).

3.17

matrix

organic or inorganic material, other than living cells, intentionally applied by a manufacturer to a vascular device and designed for the purpose of drug storage, local drug activity at the surface and/or enabling, retarding, delaying or modifying drug release

Note 1 to entry: The matrix can be permanent or temporary (dissolvable, absorbable or degradable); include surface treatments such as primers; be a coating with or without an active pharmaceutical ingredient, or consist of multiple excipients and/or multiple active pharmaceutical ingredients.

3.18

mode of action

means by which a product achieves an intended therapeutic effect or action

3.19

pharmacokinetics

absorption, distribution, metabolism and elimination of a drug in vivo

3.20

primary mode of action

single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the combination product

Note 1 to entry: Additional guidance on the drug-related aspects of the drug-containing part of the VDDCP can be found in International Conference on Harmonization Guideline IC H Q1A.

3.21

uniformity of drug content

comparison of the uniformity of the drug content between individual VDDCPs within each batch as compared to the labelled claim

3.22

vascular device-drug combination product

VDDCP

vascular medical device (primary mode of action) that incorporates one or more active pharmaceutical ingredients as an integral part (ancillary mode of action)

Note 1 to entry: The VDDCP can be permanently deployed (i.e. it can be an implant like a drug-eluting stent) or temporarily deployed (i.e. it can be a drug-eluting balloon, for instance).

3.23

VDDCP specification

required list of test procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for the tests described

Note 1 to entry: A specification is a critical quality standard. It establishes the set of criteria to which a VDDCP has to conform.

Note 2 to entry: Additional guidance on the drug-related aspects of the drug-containing part of the VDDCP can be found in International Conference on Harmonization Guideline IC H Q6A.