O`zbekiston respublikasi sog`liqni saqlash vazirligi toshkent farmasevtika instituti

Analyte: 
Substance for which analysis is being performed. 
27.
Annual Product Quality Review (APQR):
APQR is overall review of 
the product manufactured during the whole calendar year , for all the parameters 
including critical parameters and trend of the batches 
.
28.
Batch (or Lot):
A specific quantity of material produced in a process or 
series of processes so that it is expected to be homogeneous within specified 
limits. In the case of continuous production, a batch may correspond to a 
defined fraction of the production. The batch size can be defined either by a 
fixed quantity or by the amount produced in a fixed time interval. 
29.
BET:
A toxin that forms an integral part of the cell wall of certain 
bacteria and is only released upon destruction of the bacterial cell. Endotoxins 
are less potent and less specific than most exotoxins and do not form toxoids. 
Also calledintracellular toxin. 
30.
Binder:
An excipient used to increase powder cohesiveness,which 
increases the bonding strength of the final product.In wet granulation, they help 
to form agglomerates. 
31.
Bioavailability:
A measure of the fraction of a drug that enters the 
systemic blood circulation after oral administration. The usual measure is the 
ratio of the AUC of two different formulations of the same drug, corrected for 
dose. 
32.
Bioequivalence:
A high degree of similarity in the bioavailabilities of 

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two pharmaceutical products (of the same galenic form) from the same molar 
dose, that are unlikely to produce clinically relevant differences in therapeutic 
effects, or adverse effects, or both 
33.
Biopharmaceutical Classification System (BCS):
 
A system of classification 
of drugs based on their solubility and their permeability through the gut wall. The 
system was introduced by Professor Gordon Amidon in 1995. A soluble drug is one 
whose highest dose is soluble in 250ml or less of aqueous media over the pH range 
1 to 7,5. A permeable drug is one that is more than 90% absorbed from the human 
gut. Permeability may be determined using in vitro model systems. The BCS classes 
are Class 1: high solubility & high permeability. Class 2 = low solubility & high 
permeability. Class 3 = High solubility & low permeability. Class 4 = low solubility 
& low permeability. 
34.
Calibration: 
The demonstration that a particular instrument or device 
produces results within specified limits by comparison with those produced by a 
reference or traceable standard over an appropriate range of measurements. 
35.