New Drug Development and Routes of Drug Administration

Q-1. In new drug designing, problem arises in (AIIMS NOV 12, May 13)
a) Decreasing interaction of drug with target proteins
b) Increasing interaction of drug with non-target proteins
c) Decreasing potency of drugs
d) Increasing binding with target protein

Answer: Increasing interaction of drug with non-target proteins
Drug designing has been pursued with the primary objective of finding a compound that binds with high affinity to a target of interest.

Q-2. Good clinical practice (GCP) seen in all except (AIIMS NOV 07)
a) Preclinical trials
b) Phase I trials
c) Phase II trials
d) Phase IV trials

Answer: Preclinical trials
Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
Important point:
Good clinical practice (GCP) is laid down after completion of pre-clinical study.

Q-3. Phase 1 clinical trial is for? (AIIMS NOV 15)
a) Pharmacokinetics
b) Dose
c) Safety
d) Efficacy

Answer: Safety
Drug trials:
Phase 0: Pharmacodynamics and pharmacokinetics in humans
Phase 1: Screening for safety
Phase 2: Establishing the efficacy of the drug, usually against a placebo
Phase 3: Final confirmation of safety and efficacy
Phase 4: Safety studies during sales (Post marketing surveillance)

Q-4. Which of the following trials can be performed to determine the maximal tolerated dose of drug? (AIIMS MAY 13)
a) Case control
b) Phase I
c) Phase II-RCT
d) Phase VI-RCT

Answer: Phase I
See above explanation.

Q-5. Post marketing surveillance is a part of which phase of clinical trial? (AIIMS MAY 2016)
a) Phase-1
b) Phase-2
c) Phase-3
d) Phase-4

Answer: Phase-4
See above explanation.

Q-6. Weight of rabbit in pharmacological studies (AIIMS NOV 2016)
a) 1-1.5 kg
b) 1.5-2 kg
c) 4-5 kg
d) 10-12 kg

Answer: 1.5-2 kg
Weight and age of rabbit in pharmacological studies:
Adult weight: 1.5-3.0 Kg
Age suitable for experiment: 5-6 months

Q-7. Orphan drugs are (AIIMS MAY 13)
a) Drugs for orphans
b) Drug for treating rare diseases
c) Rare drugs for treating common diseases
d) Drugs that are used very rarely

Answer: Drug for treating rare diseases
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
A rare disease, also referred to as an “orphan disease,” is any disease that affects a small percentage of the population. Most rare diseases are genetic, and thus are present throughout the person’s entire life, even if symptoms do not immediately appear.

Q-8. Pharmaco-vigilance is done for monitoring (AIIMS MAY 2010)
a) Drug price
b) Unethical practices
c) Drug safety
d) Pharmacology students

Answer: Drug safety
Pharmaco-vigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
The aims of Pharmaco-vigilance are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

Q-9. Pharmaco-Vigilance is used for (AIIMS MAY 09)
a) To monitor drug toxicity
b) To monitor unauthorized drug manufacture
c) Monitoring of students
d) Check costs

Answer: To monitor drug toxicity
See above explanation.

Q-10. All present on drug advertisement except (AIIMS NOV 2016)
a) Expiry date
b) Reference of the information
c) Rare dangerous side effect
d) Common side effect

Answer: Expiry date
WHO criteria for drug advertisements includes information related to generic name of the drug, indication, dosage, precaution, contraindication, adverse effect, price, postal address of pharmaceutical company, and reference to scientific literature.

Q-11. Store a drug in a cool place refers to
a) Below freezing point of water
b) 0 degree C
c) 2-8 degree C
d) 8 to 15 degree C

Answer: 8 to 15 degree
Cool place refers: Temperature between 8 degree C and 15 degree C
Cold place refers: Any temperature not exceeding 8 degree C

Q-12. Schedule of drug to be sold only on prescription
a) Category H
b) Category X
c) Category S
d) Category P

Answer: H
Schedule G: Most of these drugs are hormonal preparations. The drug label must display the text “Caution:
Schedule H (Prescription drugs): The drug label must display the texts Rx and warning: To be sold by retail on the prescription of a Registered Medical practitioner only.
Schedule X: All the regulations of Schedule H apply. The retailer must keep a copy of the prescription for two years.

Q-13. Nitroglycerine in sublingual route is more effective because
a) It is ionic and less lipid soluble
b) It is ionic and more lipid soluble
c) It is non-ionic and less lipid soluble
d) It is non-ionic and more lipid soluble

Answer: It is non-ionic and more lipid soluble
Drugs that are non-ionic and highly lipid soluble are effectively absorbed by sublingual route. The drugs nitroglycerin and buprenorphine are administered by this route.

Q-14. Which of the following can be given orally?
a) Cytosine
b) Actinomycin D
c) Doxorubicin
d) Mesna

Answer: Mesna
Mesna can be administered intravenously or orally.
Important point:
Mensa is given along with alkylating agents to prevent nephro-toxicity due to Cyclophosphamide.

Q-15. If a drug is given through skin, maximum percutaneous absorption of given drug (AIIMS NOV 2016)
a) Posterior auricular
b) Scalp
c) Scrotum
d) Plantar surface

Answer: Posterior auricular
Order of percutaneous absorption of drug applied topically:
Posterior auricular > Scrotum > Scalp > Fore arm > Plantar surface