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  PHARMACOLOGY
 

OBJECTIVE
 

Regulatory pharmacological studies constitute an essential part of pre-clinical investigations and are designed to find out whether a substance has potential pharmacological activity in organ systems other than the one targetted for therapeutic purposes.

It is desirable that a candidate drug to be developed should be devoid of any significant effect on other systems. These studies intend to collect information on the occurrence of potential adverse effects.

The regulatory pharmacology programme at the Institute consists of the following test systems in experimental animals, usually mice and rats, in the following areas:
 
General behavioural study and LD50 determination
Effect on general activity of animal (mice) covering Awareness, Mood, CNS excitation, posture, motor incoordination, muscle tone reflexes, various autonomic functions (e.g. pupil size, temperature, respiratory rate, urination, salivation etc.) and LD50 determination in mice (i.p./oral route).

CNS
Test substance is assessed for the following effects: spontaneous motor activity (SMA) (computerised recording), proconvulsant, anti-depressant, analgesic activities.

Skeletal muscle
Effect on coordinated locomotor activity is assessed using (Roto-Rod).

Cardiovascular system
Test substance is evaluated in anaesthetised rats for blood pressure, heart rate, ECG.

Respiration
Effect on respiration rate and depth is assessed in anaesthetised rats.

Gastrointestinal tract
Effect of test substance is assessed on gastrointestinal transit time, gastric acid secretion and irritation (ulcer formation).

Renal function
The Regulatory Pharmacological facility at CDRI provides a full range of in vitro and in vivo pharmacological studies in confirmity with the requirements of international regulatory bodies for development of drugs.

The expertise, experience, infrastructure (equipments) available are probably the best available in the country.

The studies conducted follow fully documented protocols and standard operating procedures under GLP-like conditions.

Results are generated in time-bound manner and high accuracy is maintained. Reports cover complete information such as objectives, full detail of test substances, test system used, summary/conclusion of the findings and signed by Study Director and Senior Scientist Supervisor.

<< CNS / CVS
 
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