iii. The drug categorization research conducted at the University of Michigan and
the University of Uppsala on the permeability of drug substances; and
iv. The Scale-up and Post Approval Changes (SUPAC) Task Force established by
the Centre for Drug Evaluation and Research (CDER) Chemistry, Manufacturing
and Controls Coordinating Committee to develop guidance on scale-up and other
3.3 TERMINOLOGIES USED IN GUIDANCE DOCUMENT
A specific quantity of a drug or other material produced according to a single
manufacturing order during the same cycle of manufacture and intended to have
uniform character and quality, within specified limits [21 CFR 210.3(b)(2)].
Continuous or unbroken site or a set of buildings in adjacent city blocks.
Case A Dissolution of Q = 85% in 15 minutes in 900 millilitres (mL) of 0.1 N
hydrochloride (HCl), using the United States Pharmacopeia (USP) <711> Apparatus 1
at 100 revolutions per minute (rpm) or Apparatus 2 at 50 rpm.
Case B Multi-point dissolution profile in the application/compendial medium at
15, 30, 45, 60, and 120 minutes or until an asymptote is reached for the proposed and
currently accepted formulation.
Case C Multi-point dissolution profiles performed in water, 0.1 N HCl, and USP
buffer media at pH 4.5, 6.5, and 7.5 (five separate profiles) for the proposed and
currently accepted formulations. Adequate sampling should be performed at 15, 30,
45, 60, and 120 minutes until either 90% of the drug from the drug product is dissolved
or an asymptote is reached. A surfactant may be used with appropriate justification.
A drug product is a finished dosage form (e.g. tablet, capsule, or solution) that contains
a drug substance, generally, but not necessarily, in association with one or more other
ingredients [21 CFR 314.3(b)]. A solid oral dosage form includes tablets, chewable
tablets, capsules, and soft gelatine capsules.
An active ingredient that is intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease, or to
affect the structure of any function of the human body, but does not include
intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)].
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