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  • Key Process Parameter (KPP)

    (CMC-BWG) An adjustable parameter (variable) of the process that, when maintained within a narrow range, ensures optimum process performance. A key process parameter does not meaningfully affect critical product quality attributes. Ranges for KPPs are established during process development, and changes to operating ranges will be managed within the quality system.

  • KGF

    Keratinocyte Growth Factor

  • kGy

    Kilogray

  • KHL

  • KHP

    Potassium Hydrogen Phthalate

  • KHz

    Kilohertz

  • Kidney Plasminogen Activator

    A precursor to the enzyme urokinase that has blood-clotting properties.

  • Kilobase (kb)

    Unit of length for DNA fragments equal to 1000 nucleotides (kilo base pairs of DNA).

  • Kilobyte (KB)

    Approximately one thousand bytes. This symbol is used to describe the size of computer memory or disk storage space. Because computers use a binary number system, a kilobyte is precisely 210 or 1024 bytes.

  • Kilocalorie (kcal)

    It is equal to 1000 cal.

  • Kilogram (kg)

    A metric unit of mass. Equals 1000 grams. Also equals 2.20462 pounds.

  • Kilogray (kGy)

    1000 grays, an SI unit used to measure the absorbed dose of radiation, e.g., in food irradiation.

  • Kinase

    An enzyme catalyzing phosphorylation of an acceptor molecule by adenosine triphosphate (ATP).

  • Kit Identifier

    Unique identifier for a packaged unit used within a clinical trial. (Synonyms: Dispensing Unit, Box Number, Pack ID, IRT Number, Med ID, etc.)

  • Kit Number

    Unique identifier for a packaged unit used within a clinical trial.

  • Kits

    A package of IMP supplies with more than one container within it and usually dispensed as a single unit (with multiple containers) to a patient.

  • KLOC

    One thousand lines of code.

  • KM

    Knowledge Management

  • Knockout

    An animal resulting from an embryonic stem cell in which a normal functional gene has been replaced by a non-functional form of the gene. This technique is used extensively in mice – much can be learned about the function of a gene by studying the phenotype of animals that lack the peptide product of that gene.

  • Knowledge Management

    (ICH Q10) Systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components.

  • Knowledge Space

    (CMC-BWG) Multi-dimensional region encompassing internally and externally derived knowledge. Relating to properties of API, formulation design, quality of raw materials, process type, etc. Explored and/or modeled, relevant to the product under development.

  • Kommerzielle Handelssoftware (IEEE)

  • KPI

    Key Performance Indicator

  • KS

    Kawasaki's Syndrome

  • KS

    Kaposi's Sarcoma