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EDI WOW > QUIZ 1 LEC > Flashcards

QUIZ 1 LEC Flashcards

1
Q

Addresses the requirements for control of the quality of methods of analysis (validation)and registration of the pharmaceuticals for Human Use

A

INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) Guidelines

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2
Q

Standardized the requirements of
medicine regulation.

A

INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) guideline

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3
Q

Facilitates access to quality-assured, safe and effective health products by assessing medicines, vaccines and medical devices for priority diseases, while working to fight the growing issue or antibacterial resistance.

A

WORLD HEALTH ORGANIZATION (WHO)

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4
Q

Leading the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products.

A

PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/s)

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5
Q

Provide assistance to each other in the form of training and research facilities in the educational, professional, technical and administrative spheres.

A

ASSOCIATION OF SOUTHEAST ASIAN NATIONS (ASEAN)

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6
Q

ASEAN countries

A

Brunei Darussalam
Burma
Cambodia
Indonesia
Laos
Malaysia
Philippines
Singapore
Thailand
Vietnam

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7
Q

an independent,
non-governmental international organization with a membership of 170 national standards bodies.

A

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

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8
Q

International standards ensure that
the products and services you use
daily are safe, reliable, and of high
quality.

A

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

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9
Q

provides an exact
description of how the analysis is carried out. It should describe in detail the steps
necessary to perform each analytical test.

A

ANALYTICAL PROCEDURE

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10
Q

mainly used to quantify any compound in the sample or to determine the amount of each compound present in the sample.

A

TECHNIQUE OF ANALYSIS

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11
Q

5 methods of analysis

A

CHEMICAL METHOD
ELECTRICAL METHOD
INSTRUMENTAL METHOD
CHROMATOGRAPHIC METHOD AND ELECTROPHORETIC METHOD
BIOLOGICAL AND MICROBIOLOGICAL METHOD

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12
Q

Used to determine the concentration of component in the sample

A

INSTRUMENTAL METHOD OF ANALYSIS

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13
Q

Employed to measure physical properties of substance like absorbance, transmittance, fluorescence etc.

A

INSTRUMENTAL METHOD OF ANALYSIS

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14
Q

Study of the interaction of LIGHT/EMR with matter

A

SPECTROSCOPY

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15
Q

Involves measurement of the amount of EMR that is absorbed, emitted or scattered by a sample to perform an assay.

A

SPECTROCOPY

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16
Q

Quantitative in nature

A

SPECTROSCOPY

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17
Q

A branch of electromagnetic spectroscopy concerned with the quantitative measurement of the reflection or transmission properties of a material as a function of wavelength.

A

SPECTROPHOTOMETRY

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18
Q

Pharmacopoeial methods rely heavily
simple analysis by UV/Visible spectrophotometry to determine
active ingredients in formulations.

A

SPECTROPHOTOMETRY

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19
Q

RADIATION SOURCES/ LIGHT SOURCES

A
  1. Deuterium Lamp
  2. Hydrogen Lamp
  3. Tungsten Filament Lamp
  4. Xenon Arc Lamp
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20
Q

this device enables the selection of relatively narrow bonds of wavelengths from a broad brand of radiation.

A

WAVELENGTH SELECTOE

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21
Q

prevent the passage of radiation at all wavelengths except in a fixed wavelength region.

A

FILTERS

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22
Q

One if the most widely used techniques in analytical chemistry, capable of producing accurate and precise results.

A

UV / VISIBLE SPECTROPHOTOMETRY

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23
Q

Procedures using this technique are found in analytical, clinical, and research laboratories, and fins extensive use in quality assurance

A

UV AND VISBLE SPECTROPHOTOMETRY

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24
Q

is used routinely to monitor in vitro release of active ingredients from formulations.

A

UV SPECTROPHOTOMETRY

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25
Q

NIR radiation has good penetration properties and thus minimal sample preparation is required and thick sample layers can be used to compensate for the weakness of NIR absorption

A

NIR SPECTROMETRY

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26
Q

Has the potential to replace chromatography as a method for more rapid analysis of multicomponent samples.

A

NIR SPECTROMETRY

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27
Q

is a very important and widely used sample characterization and analytical technique, whether the sample is in the form of a gas, a liquid, paste-like or solid.

A

Mid-IR SPECTROMETRY

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28
Q

A powerful method that can be applied to diverse biological prblems

A

FLUORESCENCE SPECTROMETRY

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29
Q

5 components of spectroscopic instruments:

A

LIGHT SOURCE

WAVELENGTH ISOLATOR

SAMPLE CELL / CUVETTE

DETECTOR

SIGNAL PROCESSING AND READOUT UNIT

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30
Q

Instruments illuminate samples with short wavelength light in the visible or ultraviolet wavelength regions.

A

FLUORESCENCE SPECTROMETRY

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31
Q

Is a technique used to analyze the absorption of light by molecules in the ultraviolet snd visible regions of the electromagnetic spectrum.

A

UV/VISIBLE SPECTROPHOTOMETRY

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32
Q

Relationship between absorbance, concentration, and path length, which states that absorbance is directly proportional to concentration and path length.

A

BEER-LAMBERT LAW

33
Q

A deuterium lamp for the UV region from 109 to 350 nm and a quartz halogen or tungsten lamp for the visible region from 350-900 nm

A

LIGHT SOURCES

34
Q

Deuterium lamp for the UV region range from

A

190-350 nm

35
Q

Quartz halogen or tungsten lamp for the visible region:

A

350-900 nm

36
Q

Used to dispersed the light into its constituents wavelengths, which are further selected by the slit. It is rotated so that a range of wavelengths id passed through the sample as the instrument scans across the spectrum.

A

MONOCHROMATOR

37
Q

May be designated to split the light beam so that the beam passes through sample compartments, and, in such a double-beam compartment, a blank solution can then be used in one compartment to correct the reading or spectrum of the sample.

38
Q

The sample is prepared according to the requirements of the analysis. This may involve diluting the sample, adding reagents, or preparing a standard curve for quantification.

A

PREAPARATION OF THE SAMPLE

39
Q

The spectrophotometer is set to the appropriate wavelength or wavelength analysis.

A

SETTING UP THE SPECTROPHOTOMETER

40
Q

Before measuring the sample, a baseline measurement is usually taken using a blank solution that does not contain the analyte of interest.

A

BASELINE CORRECTION

41
Q

The sample is placed in the spectrophotometer, and the absorbance or transmittance of light is measured. This measurement is recorded and used for analysis.

A

MEASURING THE SAMPLE

42
Q

The absorbance or transmittance of the sample is compared to a standard curve or a known equation to calculate the concentration of the analyte in the sample.

A

CALCULATING THE RESULT

43
Q

The data is obtained from the spectrophotometer is analyzed using software or mathematical techniques to obtain the final result. This may involve putting a standard curve, calculating the concentration of the analyte, or interpreting the spectrum of the sample.

A

DATA ANALYSIS

44
Q

API

A

ACTIVE PHARMACEUTICAL INGREDIENTS

45
Q

BE

A

BIOEQUIVALENCE

46
Q

BCS

A

BIOPHARMACETICS CLASSIFICATION SUSTEM

47
Q

Approval of a generic oral solid formulation of an API based in strictly defined dissolution criteria as a surrogate for an in vivi bio equivalence test.

48
Q

EML

A

WHO Model list of Essential Medicines

49
Q

HHS-FDA

A

DEPARTMENT OF HUMAN HEALTH; FEDERAL DRUG AGENCY, THE UNITED STATES OF AMERICA

50
Q

WHO working document QAS/04.093 entitled “Revision of multi-source (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability”

A

MULTISOURCE DOCUMENT

51
Q

SUPAC

A

Scale up and Post-Approval Changes

52
Q

this was proposed in 1995 by Amidon et al. It is a scientific framework which divides the APIs into four groups, according to their solubility and permeability properties.

A

BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)

53
Q

Who proposed the Biopharmaceutics Classification System (BCS)

A

AMIDON ET AL in 1995

54
Q

High solubility-high permeability

A

BSC CLASS I

55
Q

low solubility- high permeability

A

BCS CLASS II

56
Q

High solubility - low permeability

A

BCS CLASS III

57
Q

Low solubility - low permeability

A

BCS CLASS IV

58
Q

According to WHO, when an API shows a dose/solubility ration less than 250 ml at 37 degree Celsius over a pH range of 1.2-6.8.

A

HIGH SOLUBLE

59
Q

According to WHO when an API is absorbed to an extent of 85% or more.

A

HIGHLY PERMEABLE

60
Q

The permeability criterion was relaxed from ____ in the FDA Guidance to ____ in the WHO multisource document.

61
Q

An IR drug product is considered rapidly dissolving when no less than 85% of the labeled amount of the drug substance dissolves within 30 minutes

A

DISSOLUTION TESTING

62
Q

Release of >85% of the labelled amount of drug in 15 minutes

A

VERY RAPIDLY DISSOLVING

63
Q

Release of >85% of the labelled amount of drug in 30 minutes

A

RAPIDLY DISSOLVING

64
Q

The ability of an active ingredient or a drug product to retain its properties within specified limits throuought its shelf-life.

65
Q

Consists of a series of tests in order to obtain an assurance of the stability of a drug product, namely maintenance of the specifications of the drug product packed in its specified packaging material and stored in the established storage condition within the determined time period.

66
Q

Determining the earliest times at which the 95 percent confidence limit for the mean intersects the proposed acceptance criterion/specification.

A

LINEAG REGRESSION

67
Q

Analysis of Covariance (ANCOVA)

A

POOLABILITY TESTS BETWEEN BATCHES

68
Q

Multi-factor, full design studies

A

STATISTICAL MODELING

69
Q

“Trueness” of an analytical method, is the closeness of test results obtained by that method to the true or acceptable reference value.

70
Q

Ways to determine Accuracy:

A
  1. REFERENCE MATERIAL METHOD
  2. SPKIED PLACEBO METHOD
  3. STANDARD ADDITION METHOD
  4. COMPARATIVE METHOD
  5. PROFICIENCY TESTING METHOD
71
Q

Degree of agreement among individual test results by repeatedly applying that method to several replicates of the homogenous test samples.

72
Q

Same lab, same analysts, same equipment

A

REPEATABILITY OR INTRA-ASSAY

73
Q

Measures the “among” and “within” lab presicion.

A

REPRODUCIBILITY

74
Q

Measure “within” lab precision of a single lab.

A

INTERMEDIATE PRECISION

75
Q

Ability of the method to produce test results that are proportional to the concentration of the analyte in the sample within a given range.

76
Q

The interval between the lower and the upper limits of the amount of the analyte providing sufficient accuracy and precision.

A

LINEAR RANGE

77
Q

Ability to assess unequivocally the analyte in the presence of components which may be expected to be present.

A

SPECIFICITY

78
Q

The measure of its capacity to remin unaffected by small but deliberate changes in the method of parameters.

A

ROBUSTNESS

EDI WOW (8 decks)

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