FINISHED PRODUCTS QUALITY CONTROL (BIOLOGICAL, GLUCAGON, MICORBIOLOGICAL ASSAY)

Biological Assay

Includes the quantitative assay of drugs using intact animals, animal preparations, isolated living tissues and cells, or microorganisms

Bioassay

These are conducted by determining the amount of a preparation of unknown potency required to produce a definite effect on suitable testanimals or organs under standard conditions

Biological Standardization Procedures

These are generally are less precise, more time-consuming, and more expensive to conduct than are chemical assays.

1. If the chemical identity of the active principle has not been elucidated fully.

2. If no adequate chemical assay has been devised for the active principle, although its chemical structure has been established (e.g., insulin).

3. If the drug is composed of a complex mixture of substances of varying structure and activity (e.g. digitalis).

4. If purification of the crude drug, sufficient for the performance of a chemical assay, is not possible or practical (e.g., the separation of vitamin D from certain irradiated oils).

5. If the chemical assay is not a valid indication of biological activity, due, for example, to lack of differentiation between active and inactive isomers

Biological standardization procedures generally are less precise, more time-consuming, and more expensive to conduct than are chemical assays; therefore, they generally are reserved for use:

Equal

The amount of the test sample required to produce an effect ______ to that produced by a defined amount of the reference standard is determined.

Pigeon

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Digitalis

Cat

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Glucagon Injection

Chicken

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Oxytocin Injection

Male rat

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Vasopressin Injection

Female Rat (20-23 days)

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Chorionic Gonadotropin

Rat, same but of either sex

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Corticotropin

Rabbit

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Tubocurarine Injection

-Insulin Injection

-Metocurine Injection

Sheep Blood Plasma

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Heparin

-Protamine Sulfate

Rachitic Rat

BIOLOGICAL ASSAYS (DRUG AND THE ANIMAL EMPLOYED)

-Cod liver oil

Glucagon

It is used in the treatment of acute hypoglycemic reactions, especially in diabetics with insulin-induced hypoglycemia.

Ex vivo

This is a procedure in which the drug’s effects are assessed on a primary culture of rat liver cells

Albino mice

BIOLOGICAL ASSAY (TEST AND THE ANIMAL)

-Systemic Injection Test (Elastomeric material esp. plastics)

Albino Rabbits

BIOLOGICAL ASSAY (TEST AND THE ANIMAL)

-Intracutaneous Test (Elastomeric material esp. plastics)

-Eye irritation test (Medical devices, ophthalmic containers)

Rabbits

BIOLOGICAL ASSAY (TEST AND THE ANIMAL)

-Implantation test (Material in direct contact with tissue)

Purpose of Microbiological Assay

-To determine the activity/potency of antibiotics.

-To facilitate in determination of the antibiotic appropriate for patient recovery

-Cylinder Plate or “Plate Assay”

-Turbidimetric or “Tube Assay”

What are the two methods of Microbiological Assay?

Cylinder Plate or “Plate Assay“

-Diffusion of the antibiotic from a vertical cylinder through a solidified agar layer in a Petri dish

-Circular area around the cylinder is observed (Zone of Inhibition)

Zone of Inhibition

What do you called the circular area around the cylinder is observed in the cylinder plate?

Antibiotic Disk

CYLINDER PLATE OR “PLATE ASSAY”

-What is being added to an agar plate spread with bacteria

Ineffective Antibiotic

CYLINDER PLATE OR “PLATE ASSAY”

-Bacterial concentration does not change

Effective Antibiotic

CYLINDER PLATE OR “PLATE ASSAY”

-Bacterial concentration is reduced around disc; zone of inhibition is visible

Very Effective Antibiotic

CYLINDER PLATE OR “PLATE ASSAY”

-Bacterial concentration is significantly reduced around disc; large zone of inhibition is visible

Turbidimetric or “Tube Assay“

-Inhibition of the growth of a microbe in a uniform solution of the antibiotic in a fluid medium that is favorable to the growth of the microbe in the absence of the antibiotic.

-Instead of ZOI, you measure TURBIDITY using spectrophotometer.

-↑ turbidity, ↓ potency

Turbidity using Spectrophotometer

Instead of Zone of Inhibition in the turbidimetric or tube assay you measure?