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

Metabolite - Any of the various organic compounds produced by metabolism.
22. summation (additivity) - the phenomenon of additive effects induced by the 
combined action; 
23. potentiation (synergy) - Strengthening of effect; Effect more than the 
summation; 
24. antagonism - the effect of the combined effects of less expected in the simple 
summation.
25. Analytical Procedure: The analytical procedure refers to the way of 
performing the analysis. It should describe in detail the steps necessary to perform 
each analytical test. This may include but is not limited to: the sample, the reference 
standard and the reagents preparations, use of the apparatus, generation of the 
calibration curve, use of the formulae for the calculation, etc. 
26. 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. Change-Being-Effected Supplement (CBE) - A submission to an approved 
application reporting changes that FDA has identified as having moderate potential 
to adversely affect the identity, strength, quality, purity, or potency of a product as 
they may relate to the safety or effectiveness of the product. A CBE supplement 
must be received by FDA before or concurrently with distribution of the product 
made using the change. 
36. CEP: CEP stands for Certification of suitability of European Pharmacopoeia 
monographs. COS (―Certificate of Suitability‖) means the same and, even if often 
used, is not the official acronym. 
37. Combination product: A drug product which contains more than one drug 
substance. 
38. Contamination: The undesired introduction of impurities of a chemical or 
microbiological nature, or of foreign matter, into or onto a raw material, 
intermediate, or API during production, sampling, packaging or repackaging, 
storage or transport. 
39. COS: A certificate provided to the manufacturer by the European Directorate 
for the Quality of Medicines & HealthCare to certify that the relevant monograph in 
the European Pharmacopoeia adequately controls the substance as manufactured by 
the company at the time the certificate was granted. 
40. Degradation Product: An impurity resulting from a chemical change in the 
drug substance brought about over time and/or by the action of e.g., light, 
temperature, pH, water, or by reaction with an excipient and/or the immediate 
container/closure system. Also called decomposition product. 
41. Detection Limit: The detection limit of an individual analytical procedure is 
the lowest amount of analyte in a sample which can be detected but not necessarily 
quantitated as an exact value. 
42. Dissolution: The process by which drug dissolves out of a dosage form and is 
made available for absorption from the gastro-intestinal tract. In vitro measurements 

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are made in a range of apparatus types. The requirements for different types of 
dosage forms are given in each pharmacopoeia. 
43. Diuretics: Drugs that increase the quantity of urine produced by kidney. 
44. Dosage form: A pharmaceutical product type (e.g., tablet, capsule, solution, 
cream) that contains a drug substance generally, but not necessarily, in association 
with excipients. 
45. Drug substance: The unformulated drug substance that may subsequently be 
formulated with excipients to produce the dosage form. 
46. Enantiomeric Impurity: A compound with the same molecular formula as 
the drug substance that differs in the spatial arrangement of atoms within the 
molecule and is a non-superimposable mirror image.