Question6 Please, plan the monitoring procedures for a pre-clinical study on non-human mammals of a newly invented drug “X- medicine” acting on the reduction of allergic reactions by reducing of secretion of Histamine. State what adverse reactions could be anticipated in animals, compared with the well-known antihistamine drugs acting as selective blockers of H1 receptors. What special monitoring issues would you plan in regarding with this aspect?

Apr 7 • Clinical Research Associate, Clinical trail, CRA certification, cracertification_Q&A, cracertification.co.uk • 3363 Views • Comments

Question2. Please, plan the monitoring procedures for a pre-clinical study on non-human mammals of a newly invented drug “X- medicine” acting on the reduction of allergic reactions by reducing of secretion of Histamine. State what adverse reactions could be anticipated in animals, compared with the well-known antihistamine drugs acting as selective blockers of H1 receptors. What special monitoring issues would you plan in regarding with this aspect? 

 

Answer: Imagine that we have invented drug “X-medicine” which helps to reduce the secretion
of Histamine. We have to analyze the adverse reactions that could be
anticipated in animal experiments and we also have to compare it with the
known antihistamines drugs acting as selective blockers of H1 receptors.
We are anticipating following adverse reactions in animals:

 

1. Physical adverse reactions – dryness in one’s mouth, brash, gastritis,
rarely dysfunction of liver.
2. CNS’s adverse reactions – a headache, fatigue, drowse, an antianxiety
effect.
3. Allergic reactions – skin rash, anaphylactic shock.
I am comparing my drug to   Loratadine (Claritine). It
has the same mechanism of action and similar adverse reactions. All things
considered, I have planed following monitoring procedures.

Monitoring procedures for pre-clinical study of “X-medicine”.

1. Performing hematological, biochemical, immunological and genetic tests.
2. Electrocardiography.
3. Ophthalmic examinations.
4. Neurobehavioral tests.
5. Endoscopic test (if it possible on animals).
7. Daily physical examinations: body weight, food consumption levels,
auscultation, palpation, growth, pain and other severe adverse effects

8. Tissue analysis along with enzyme effects
9. Postmortem examination of the animal

10. Blood reactions and their evaluations will also need
to be taken care of.

 

In regarding to adverse reactions that referred about I can suggest
endoscopic test (if it possible on animals), histological examination of
pancreas, determination of concentration of neurotransmitters in blood and
cerebral spinal fluid. This analysis needs for investigating CNS’s, cardiovascular and respiratory adverse reactions.

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