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Terms
19問 • 1年前
  • ユーザ名非公開
    • 通報

    問題一覧

  • 1

    ANY ingredient used in the manufacture of a drug product, including those that may not be present in the finished product.

    Component

  • 2

    means a specific homogenous quantity of a drug or in case of drug produced according to single manufacturing order during the same cycle of manufacture

    Batch

  • 3

    A batch or any PORTION of a batch having uniform specified quality and a distinctive identifying lot number.

    Lot

  • 4

    Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.

    Lot Number

  • 5

    specificity, linearity, range, accuracy, precision, robustness, and sample and standard stability in which assay methods are validated

    Validation Characteristics

  • 6

    often called “appearance” on a specification and is a qualitative description of the dosage form

    Descriptions

  • 7

    document that is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria

    Specifications

  • 8

    determines the strength or content of the API in the dosage form and is sometimes called a “CONTEST TEST”

    Assay

  • 9

    Particles are loose aggregates

    Flocculated

  • 10

    Formed rapidly in sedimentation

    Flocculated

  • 11

    Arrangement of sediements are loose aggregates that are easily to redispersed

    Flocculated

  • 12

    Appearance is unsighty upon rapid sedimentation

    Flocculated

  • 13

    Sedimentation rate is high

    Flocculated

  • 14

    Particles are seperate entities

    Deflocculated

  • 15

    Formed slowly in sedimentation

    Deflocculated

  • 16

    Sedimentation rate is low

    Deflocculated

  • 17

    Appearance is pleasing, it remains suspended

    Deflocculated

  • 18

    Arrangement of sediements are close aggregates that are difficult to redispersed and prone to caking

    Flocculated

  • 19

    Crytal Growth

    Ostwald Ripening

    • Module 2 Part 1

    Module 2 Part 1

    ユーザ名非公開 · 100問 · 1年前

    Module 2 Part 1

    Module 2 Part 1

    100問 • 1年前
    ユーザ名非公開

    Module 1

    Module 1

    ユーザ名非公開 · 13問 · 1年前

    Module 1

    Module 1

    13問 • 1年前
    ユーザ名非公開

    Module 2

    Module 2

    ユーザ名非公開 · 100問 · 1年前

    Module 2

    Module 2

    100問 • 1年前
    ユーザ名非公開

    Antibiotics

    Antibiotics

    ユーザ名非公開 · 10問 · 1年前

    Antibiotics

    Antibiotics

    10問 • 1年前
    ユーザ名非公開

    Module 2 Part 2

    Module 2 Part 2

    ユーザ名非公開 · 100問 · 1年前

    Module 2 Part 2

    Module 2 Part 2

    100問 • 1年前
    ユーザ名非公開

    Module 2 (Part 2)

    Module 2 (Part 2)

    ユーザ名非公開 · 100問 · 1年前

    Module 2 (Part 2)

    Module 2 (Part 2)

    100問 • 1年前
    ユーザ名非公開

    Module 2 Part 3

    Module 2 Part 3

    ユーザ名非公開 · 85問 · 1年前

    Module 2 Part 3

    Module 2 Part 3

    85問 • 1年前
    ユーザ名非公開

    Module 4

    Module 4

    ユーザ名非公開 · 100問 · 1年前

    Module 4

    Module 4

    100問 • 1年前
    ユーザ名非公開

    Module 4 Part 2

    Module 4 Part 2

    ユーザ名非公開 · 100問 · 1年前

    Module 4 Part 2

    Module 4 Part 2

    100問 • 1年前
    ユーザ名非公開

    Module 4 Part 3

    Module 4 Part 3

    ユーザ名非公開 · 60問 · 1年前

    Module 4 Part 3

    Module 4 Part 3

    60問 • 1年前
    ユーザ名非公開

    Module 2 (Part 4)

    Module 2 (Part 4)

    ユーザ名非公開 · 68問 · 1年前

    Module 2 (Part 4)

    Module 2 (Part 4)

    68問 • 1年前
    ユーザ名非公開

    Randome Questions

    Randome Questions

    ユーザ名非公開 · 13問 · 1年前

    Randome Questions

    Randome Questions

    13問 • 1年前
    ユーザ名非公開

    1

    1

    ユーザ名非公開 · 100問 · 1年前

    1

    1

    100問 • 1年前
    ユーザ名非公開

    Module 2 (Part 5)

    Module 2 (Part 5)

    ユーザ名非公開 · 100問 · 1年前

    Module 2 (Part 5)

    Module 2 (Part 5)

    100問 • 1年前
    ユーザ名非公開

    2

    2

    ユーザ名非公開 · 100問 · 1年前

    2

    2

    100問 • 1年前
    ユーザ名非公開

    Module 2 (Part 6)

    Module 2 (Part 6)

    ユーザ名非公開 · 68問 · 1年前

    Module 2 (Part 6)

    Module 2 (Part 6)

    68問 • 1年前
    ユーザ名非公開

    Module 4 Part 1

    Module 4 Part 1

    ユーザ名非公開 · 5問 · 1年前

    Module 4 Part 1

    Module 4 Part 1

    5問 • 1年前
    ユーザ名非公開

    問題一覧

  • 1

    ANY ingredient used in the manufacture of a drug product, including those that may not be present in the finished product.

    Component

  • 2

    means a specific homogenous quantity of a drug or in case of drug produced according to single manufacturing order during the same cycle of manufacture

    Batch

  • 3

    A batch or any PORTION of a batch having uniform specified quality and a distinctive identifying lot number.

    Lot

  • 4

    Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.

    Lot Number

  • 5

    specificity, linearity, range, accuracy, precision, robustness, and sample and standard stability in which assay methods are validated

    Validation Characteristics

  • 6

    often called “appearance” on a specification and is a qualitative description of the dosage form

    Descriptions

  • 7

    document that is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria

    Specifications

  • 8

    determines the strength or content of the API in the dosage form and is sometimes called a “CONTEST TEST”

    Assay

  • 9

    Particles are loose aggregates

    Flocculated

  • 10

    Formed rapidly in sedimentation

    Flocculated

  • 11

    Arrangement of sediements are loose aggregates that are easily to redispersed

    Flocculated

  • 12

    Appearance is unsighty upon rapid sedimentation

    Flocculated

  • 13

    Sedimentation rate is high

    Flocculated

  • 14

    Particles are seperate entities

    Deflocculated

  • 15

    Formed slowly in sedimentation

    Deflocculated

  • 16

    Sedimentation rate is low

    Deflocculated

  • 17

    Appearance is pleasing, it remains suspended

    Deflocculated

  • 18

    Arrangement of sediements are close aggregates that are difficult to redispersed and prone to caking

    Flocculated

  • 19

    Crytal Growth

    Ostwald Ripening