InterviewSolution

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101.	Which one of the following law was passed in 1945 by the Indian Government?(a) The poisons Act(b) Drug Enquiring committee(c) The Drugs and Cosmetics Rules(d) The Narcotic Drugs and Psychotropic Substances ActThis question was posed to me during an internship interview.My question comes from Controlled Release Medication in division Controlled Release Medication of Drug Biotechnology
Answer» Correct choice is (C) The Drugs and COSMETICS Rules Easiest explanation: Drug enquiring committee was ESTABLISHED in 1931. The drugs and cosmetics rules were PASSED in 1945, it regulates the MANUFACTURING, export and clinical research of drugs and cosmetics in India. The narcotic drugs and psychotropic substances act were passed in 1985.

102.	What is the full form of IND?(a) Investigated drug(b) Investigation Application(c) Investigation of New Drug Application(d) Under InvestigationThe question was posed to me by my school principal while I was bunking the class.My doubt is from Controlled Release Medication topic in section Controlled Release Medication of Drug Biotechnology
Answer» The correct answer is (c) Investigation of New DRUG Application Best explanation: Investigation New Drug Application is when a manufacturing COMPANY after LAB testing on ANIMALS submits the permission seeking the approval of the FDA. FDA reviews IND for about 30 days after that the clinical trials start once the drug is approved.

103.	Which of the following devices are included in Class II devices?(a) Bandages(b) Thermometers(c) Pacemakers(d) Micro ovensThis question was posed to me during a job interview.Question is taken from Controlled Release Medication in division Controlled Release Medication of Drug Biotechnology
Answer» Correct option is (b) Thermometers Explanation: FDA has different classes of devices such as Class I includes BANDAGES, GLOVES, Stethoscopes. These have different kind of manufacturing guidelines and PRACTICES which should be followed. Class II devices INCLUDE thermometers and endoscopes which come in contact with the body fluids. Class III devices include those which come in contact with the body fluids such as that of pacemakers and heart valves.

104.	What does the symbol Rx mean?(a) To take(b) Should date(c) How to take(d) What to takeThis question was addressed to me in semester exam.My question comes from Controlled Release Medication topic in division Controlled Release Medication of Drug Biotechnology
Answer» The correct answer is (a) To take Easiest explanation: The Rx SYMBOL means to take. It is WRITTEN above of all the PRESCRIPTION meaning to take these medicines. It is a GREEK symbol meaning to take.

105.	What is the full form of NDA?(a) Investigated drug(b) Investigation Application(c) New Drug Application(d) Under InvestigationThis question was posed to me by my school principal while I was bunking the class.This interesting question is from Controlled Release Medication topic in chapter Controlled Release Medication of Drug Biotechnology
Answer» The correct option is (c) NEW Drug Application The explanation is: Once all the trials including phase 1, 2, 3, 4 finishes and all the reports are perfect showing that the drug can be used WITHOUT any harmful effect the company submits NDA to FDA. FDA REVIEWS NDA and takes ALMOST about 19 months to approve the NDA. Once the NDA is approved the drug can be safely manufactured.

106.	Which one of the following will perfectly fit on the marked place?(a) Investigator selection(b) Patient recruitment(c) Statistical Analysis(d) Data filed and registrationThis question was posed to me in class test.The doubt is from Controlled Release Medication topic in section Controlled Release Medication of Drug Biotechnology
Answer» Correct OPTION is (c) Statistical Analysis Easy explanation: This step involves checking the RATIOS, checking the number of PATIENTS who are showing which symptom, who are not so that they can have a proper count of how many patients may get benefited from the dosage. The statistical analysis is an important part which also involves dosage, age, patient DETAILS, study details etc.

107.	What is meant by OTC drugs?(a) Drugs which are easy to manufacture(b) Drugs which are available without a prescription(c) These drugs do not need FDA approval(d) These drugs don’t have specific guidelinesThis question was posed to me by my college professor while I was bunking the class.This key question is from Controlled Release Medication in portion Controlled Release Medication of Drug Biotechnology
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108.	Which one of the following describes “double dummy”?(a) The subjects do not know which study treatment they receive(b) Patients injected with placebo and active doses(c) Fake treatment(d) Signed document of the recruited patient for the clinical trial proceduresThis question was addressed to me in final exam.Query is from Controlled Release Medication in division Controlled Release Medication of Drug Biotechnology
Answer» The correct choice is (b) PATIENTS INJECTED with placebo and active doses Easiest explanation: A form of double-blind STUDY called a “double-dummy” design allows additional insurance against bias or placebo effect. In this kind of study, all patients are given both placebo and active doses in alternating PERIODS of time during the study. The use of a placebo (fake treatment) allows the researchers to isolate the effect of the study treatment.

109.	Which one of the following law was passed in 1931 by the Indian Government?(a) The poisons Act(b) Drug Enquiring committee(c) The Drugs and Cosmetics Act(d) The Narcotic Drugs and Psychotropic Substances ActThis question was posed to me in semester exam.My question is from Controlled Release Medication topic in division Controlled Release Medication of Drug Biotechnology
Answer» Right answer is (b) Drug Enquiring committee Explanation: Drug enquiring committee was established in 1931. The drugs and cosmetics rules were PASSED in 1945, it regulates the manufacturing, export, distribution, sale and clinical RESEARCH of drugs and cosmetics in India. The NARCOTIC drugs and PSYCHOTROPIC SUBSTANCES act was passed in 1985.

110.	Which committee in India has the responsibility of looking after the drug and inquiry about its manufacture procedure?(a) Drug Enquiring committee(b) Drug Enquiry committee(c) Enquiring the Drug Manufacturing committee(d) Drug Enquiry of the produced Drug committeeI got this question during an interview.My doubt is from Controlled Release Medication in chapter Controlled Release Medication of Drug Biotechnology
Answer» The correct CHOICE is (b) Drug Enquiry committee Explanation: The Indian government appointed a Drug Enquiry Committee in 1931. The committee’s recommendations are a CREATION of a drug control machinery at the CENTER will all its branches in all the PROVINCES. The establishment of well-equipped Central Drugs Laboratory with competent staff.

111.	How many people will be selected for phase I trial?(a) The whole market will be under surveillance(b) 300-3000 people(c) 20-300 people(d) 20-50 peopleThis question was addressed to me in an online interview.My question comes from Controlled Release Medication in portion Controlled Release Medication of Drug Biotechnology
Answer» Right choice is (d) 20-50 people For explanation: Phase I trials are the first stage of testing in human subjects. Normally, a small GROUP of 20-50 healthy VOLUNTEERS will be selected. This phase includes trials designed to assess the SAFETY (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase 2 trial will be DONE on 20-300 people. Phase 3 trial will be done on 300-3000 people.

112.	What do the Pediatric Rule states?(a) No drug should be tested on children(b) No separate drug for children(c) Include usage of pediatric use of a product(d) Advertise the pediatric usageThis question was posed to me by my school principal while I was bunking the class.The doubt is from Controlled Release Medication in division Controlled Release Medication of Drug Biotechnology
Answer» The correct answer is (c) INCLUDE usage of pediatric use of a product Easy explanation: Under the Pediatric Rule introduced in 1998, companies introducing NEW active INGREDIENTS for biologics and drugs, and new dosage forms or indications for EXISTING biologics and drugs, are supposed to assess the effects of the drugs in children and include information about pediatric use of the product in their post-marketing reports.

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