QUIZ 1 LEC Flashcards by Jeehada Palinta

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

INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) Guidelines

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Standardized the requirements of
medicine regulation.

INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) guideline

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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.

WORLD HEALTH ORGANIZATION (WHO)

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

PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/s)

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

ASSOCIATION OF SOUTHEAST ASIAN NATIONS (ASEAN)

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ASEAN countries

Brunei Darussalam
Burma
Cambodia
Indonesia
Laos
Malaysia
Philippines
Singapore
Thailand
Vietnam

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

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

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

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

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

ANALYTICAL PROCEDURE

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

TECHNIQUE OF ANALYSIS

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5 methods of analysis

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

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Used to determine the concentration of component in the sample

INSTRUMENTAL METHOD OF ANALYSIS

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

INSTRUMENTAL METHOD OF ANALYSIS

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Study of the interaction of LIGHT/EMR with matter

SPECTROSCOPY

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

SPECTROCOPY

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Quantitative in nature

SPECTROSCOPY

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

SPECTROPHOTOMETRY

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

SPECTROPHOTOMETRY

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RADIATION SOURCES/ LIGHT SOURCES

Deuterium Lamp
Hydrogen Lamp
Tungsten Filament Lamp
Xenon Arc Lamp

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

WAVELENGTH SELECTOE

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

FILTERS

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

UV / VISIBLE SPECTROPHOTOMETRY

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

UV AND VISBLE SPECTROPHOTOMETRY

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

UV SPECTROPHOTOMETRY

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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

NIR SPECTROMETRY

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

NIR SPECTROMETRY

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.

Mid-IR SPECTROMETRY

A powerful method that can be applied to diverse biological prblems

FLUORESCENCE SPECTROMETRY

5 components of spectroscopic instruments:

LIGHT SOURCE WAVELENGTH ISOLATOR SAMPLE CELL / CUVETTE DETECTOR SIGNAL PROCESSING AND READOUT UNIT

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

FLUORESCENCE SPECTROMETRY

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

UV/VISIBLE SPECTROPHOTOMETRY

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

BEER-LAMBERT LAW

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

LIGHT SOURCES

Deuterium lamp for the UV region range from

190-350 nm

Quartz halogen or tungsten lamp for the visible region:

350-900 nm

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.

MONOCHROMATOR

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.

OPTICS

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.

PREAPARATION OF THE SAMPLE

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

SETTING UP THE SPECTROPHOTOMETER

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

BASELINE CORRECTION

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

MEASURING THE SAMPLE

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.

CALCULATING THE RESULT

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.

DATA ANALYSIS

API

ACTIVE PHARMACEUTICAL INGREDIENTS

BIOEQUIVALENCE

BCS

BIOPHARMACETICS CLASSIFICATION SUSTEM

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.

BIOWAIVER

EML

WHO Model list of Essential Medicines

HHS-FDA

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

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

MULTISOURCE DOCUMENT

SUPAC

Scale up and Post-Approval Changes

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.

BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)

Who proposed the Biopharmaceutics Classification System (BCS)

AMIDON ET AL in 1995

High solubility-high permeability

BSC CLASS I

low solubility- high permeability

BCS CLASS II

High solubility - low permeability

BCS CLASS III

Low solubility - low permeability

BCS CLASS IV

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.

HIGH SOLUBLE

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

HIGHLY PERMEABLE

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

90% 85%

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

DISSOLUTION TESTING

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

VERY RAPIDLY DISSOLVING

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

RAPIDLY DISSOLVING

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

STABILITY

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.

STABILITY

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

LINEAG REGRESSION

Analysis of Covariance (ANCOVA)

POOLABILITY TESTS BETWEEN BATCHES

Multi-factor, full design studies

STATISTICAL MODELING

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

ACCURACY

Ways to determine Accuracy:

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

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

PRECISION

Same lab, same analysts, same equipment

REPEATABILITY OR INTRA-ASSAY

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

REPRODUCIBILITY

Measure “within” lab precision of a single lab.

INTERMEDIATE PRECISION

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

LINEARITY

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

LINEAR RANGE

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

SPECIFICITY

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

ROBUSTNESS

QUIZ 1 LEC Flashcards

(78 cards)