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GENERAL INFORMATION

      The biological products referred to in this Pharmacopoeia are products of biological origin whose potency and safety cannot be evaluated by chemical or physical tests alone. The testing of such products for potency and safety is therefore carried out by biological procedures requiring specialized knowledge and competence. These products may be of animal or microbial or vegetable origin (vaccines, diagnostic preparations) or of animal or human origin (antisera, blood products). The biological products are distributed under aseptic conditions in sterile containers that are inert towards the contents and sealed so as to exclude contamination. Moreover special care must be taken to the handling and storage of these products. Due to the above reasons, the biological products have been separately grouped.

Classification of Biological Products Biological Products to be included in this Pharmacopoeia, are classified as follows:

      Human blood and blood products

      Antisera

      Vaccines

      Diagnostic preparation

Labelling Statements required to appear on the “label on the container” may appear on a label fastened to the immediate container, or in indelible writing in or on the body of the container itself. They should also be demonstrated on the label on the package.

      The label on the container or the label on the package states at least (1) the name of the product; (2) the name and address of the manufacturer; (3) the number of the final lot; (4) the nature and amount of the preservative added; (5) the storage condition; (6) the expiration date; (7) that it is to be well shaken before use; (8) for dried preparation, the liquid to be used for reconstitution and its volume.

Packaging and storage Biological products shall be stored at all times at controlled temperatures within a range which ensures optimal stability.

      During distribution, short periods at ambient temperatures may have to be permitted.

Preservative A biological product contains a suitable preservative in a concentration without deleterious effects on its preparation and to cause no untoward reactions in man. If phenol or thiomersal is used, the content should be conformed to the limit stated in General Testing Methods for Biological Products, p. 178.

Glossary of Terms

IU                       International Unit is the specific activity of a stated amount of the International Standard as defined by the WHO Expert Committee on Biological                                           Standardization.

                          The potency of the biological product is expressed in terms of International Unit when the assay is determined in parallel with the International Standard.

International Biological Standards and International Biological Reference Preparations International Biological Standards and International Biological Reference                       Preparations are certain preparations authorized by the World Health Organization.

                An International Biological Standard is a preparation of a biological substance to which an international unit has been assigned by the World Health                              Organization on the basis of data obtained in an international study

                 An International Biological Reference Preparation is a preparation of a biological substance which may be used for a purpose similar to that of a standard                     but which has been established without a full collaborative study or after such a study has shown that it is not appropriate to establish it as an                                    international standard.

                National Biological Standards and National Biological Reference Preparations National Biological Standards and National Biological Reference Preparations                      are specified                 

                products authorized by Ministry of Public Health, calibrated against the International Standards and International Reference Preparations to be used as                        measures for potency or toxicity of a product.

PFU                    Plaque-forming unit, the smallest quantity of virus suspension that will produce a plaque in monolayer cell cultures.

ED50                   Effective Dose 50, the dose of a vaccine which protects 50 per cent of the immunized animals against a challenge dose of virulent microorganism or toxin.

ID50                   Infective Dose 50, the dose of the micro-organism that infects 50 per cent of the animals inoculated.

Human Dose       A human dose is the dose stated on the label of the preparation being examined or in the accompanying information leaflet.

L+dose               The smallest quantity of a toxin that, in the conditions of the test, when mixed with 1 IU of antitoxin and administered by the specified route, causes the                                   death of the test animals within the given period. 

L+/10 dose         The smallest quantity of a toxin that, in the conditions of the test, when mixed with 0.1 IU of antitoxin and administered by the specified route, causes the                                 death of the test animals within the given period. 

LD50                       Lethal Dose 50, the amount of toxin or micro-organism that kills 50 per cent of a group of animals inoculated within specific time (the LD50 differs for different                         animal species and for different routes of administration).

Lf                       Limits of Flocculation, the amount of toxin or toxoid which when mixed with one International Unit (1 IU) of antitoxin gives a flocculation reaction in the shortest                       time.

Lo/10 dose          The largest quantity of a toxin that, in the conditions of the test, when mixed with 0.1 IU of antitoxin and administered by the specified route, does not cause                          symptoms of toxicity in the test animals within a given speriod.

                     

Lp/10 dose           The smallest quantity of a toxin that, in the conditions of the test, when mixed with 0.1 IU of antitoxin and administered by the specified route, causes paralysis                      in the test animals within a given period.

Lr                        The minimum amount of toxin which when combined with a fixed amount of antitoxin (usually 0.002 IU of antitoxin) in a volume of 0.2 ml causes a local                                skin reaction that is just visible.

lr/100 dose          The smallest quantity of a toxin that, in the conditions of the test, when mixed with 0.01 IU of antitoxin and injected intracutaneously causes a                                                characteristic reaction at the site of injection within a given period.

CCID50                Cell Culture Infective Dose 50, the quantity of a virus suspension that will infect 50 per cent of cell cultures inoculated.

 

MONOGRAPHS • GENERAL INFORMATION
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หมายเหตุ / Note : TP II 2011 PAGE 177-178