Drug Biotechnology Questions and Answers – Controlled Release Medication – Clinical Trials – 2

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This set of Drug Biotechnology online quiz focuses on “Controlled Release Medication – Clinical Trials – 2”.

1. Which of the following country is the most attractive location to perform clinical trials outside the United States?
a) India
b) China
c) United Kingdom
d) Germany
View Answer

Answer: b
Explanation: China with the largest population has the most clinical trials outside the United States. The United States has the clinical trial records of index 6.88, while China has an index of 6.10. India has a clinical trial index of 5.58. The United Kingdom has the index to be 5.00 and Germany has 4.69.
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2. In which phase pharmacodynamics and pharmacokinetics of a drug are studied?
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
View Answer

Answer: a
Explanation: Phase I trials are the first stage of testing in human subjects. A small (20-50) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.

3. What is the full form of SAD?
a) Secure Assessing dose
b) Single Ascending Dose
c) Sodium Ascending Dose
d) Single Amount Dose
View Answer

Answer: b
Explanation: Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time and MAD is Multiple Ascending Dose studies are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple doses of the drug.

4. What is the full form of MAD?
a) Multiple Ascending Dose
b) Managing Abnormalities Dose
c) Managing absorption dose
d) Managing Assimilation Dose
View Answer

Answer: a
Explanation: Multiple Ascending Dose studies are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple doses of the drug and SAD is Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time.

5. In which of the phase patients are involved in the trial procedure?
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
View Answer

Answer: c
Explanation: Phase III studies are randomized controlled trials on large patient groups such as 300–3,000 or more aiming at being the definitive assessment of how effective the drug is, in comparison with at present treatment method in the market. This helps in assessing the benefits and reactions on the patient as well as on the healthy individual.

6. Which of the trial phase is for pharmacovigilance?
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
View Answer

Answer: d
Explanation: Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase 1 consists of research work on a group of 20-50 people. Phase 2 and 3 has a group of 20-300 and 300 to 3000 respectively.
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7. Which of the following will not be an ethical step in the clinical trial procedure?
a) Clinical trials are not supervised well
b) Full informed consent is taken
c) Permission from the ethics committee
d) Permission before starting the run trial
View Answer

Answer: a
Explanation: Clinical trials are always closely supervised by regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee and after that permission is granted to run the trial further. To be ethical, researchers must obtain the full and informed consent of participating human subjects and the subjects must know what can be the consequences.

8. What is GCP?
a) Good cooperation project
b) Good clinical practice
c) Good cleanliness practice
d) Good Constructor provider
View Answer

Answer: b
Explanation: Good clinical practice is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. This includes the protection of human rights and provides assurance of the safety and efficacy of the trials.

9. Which one of the following will come under Scheduled X drugs?
a) Narcotics
b) Injectables
c) Serums
d) Vaccines
View Answer

Answer: a
Explanation: Medicines in India are regulated by the Central Drugs Standard Control Organization under the Ministry and Family welfare. According to this, all kinds of narcotics drugs come under Schedule X drugs. Such as opium, morphine, codeine, etc. comes under the schedules X drugs.

10. Which one of the following will be under Scheduled H and L drugs?
a) Narcotics
b) Injectable
c) Serums
d) Vaccines
View Answer

Answer: b
Explanation: Medicines in India are regulated by the Central Drugs Standard Control Organization under the Ministry and Family welfare. According to this all kinds of Injectable, antibiotics, and antibacterial comes under Scheduled H and L drugs. Biological products come under Scheduled C and Cl drugs.

11. Which one of the following will be under Scheduled C and Cl drugs?
a) Narcotics
b) Injectable
c) Antibiotics
d) Vaccines
View Answer

Answer: d
Explanation: Medicines in India are regulated by the Central Drugs Standard Control Organization under the Ministry and Family welfare. According to this all kinds of Injectable, antibiotics, and antibacterial comes under Scheduled H and L drugs. According to this, all kinds of biological products including serums and vaccines come under Scheduled C and Cl drugs.

12. Which one of the following will be under Scheduled N drugs?
a) Narcotics
b) Injectable
c) List of equipment
d) Vaccines
View Answer

Answer: c
Explanation: Medicines in India are regulated by the Central Drugs Standard Control Organization under the Ministry and Family welfare. According to this all kinds of equipment for the efficient running of the manufacturing wing, qualified personnel come under scheduled N. According to this all kinds of biological products including serums and vaccines come under Scheduled C and Cl drugs.
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13. What is the full form of IND?
a) Investigated drug
b) Investigation Application
c) Investigation of New Drug Application
d) Under Investigation
View Answer

Answer: c
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.

14. What is the full form of NDA?
a) Investigated drug
b) Investigation Application
c) New Drug Application
d) Under Investigation
View Answer

Answer: c
Explanation: 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.

15. GCP include protection of Human rights as a subject in a clinical trial.
a) True
b) False
View Answer

Answer: a
Explanation: Good Clinical Practice includes protection of human rights as a subject in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP also includes standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry, monitors are often called Clinical Research Associates.

Sanfoundry Global Education & Learning Series – Drug and Pharmaceutical Biotechnology.

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Manish Bhojasia, a technology veteran with 20+ years @ Cisco & Wipro, is Founder and CTO at Sanfoundry. He is Linux Kernel Developer & SAN Architect and is passionate about competency developments in these areas. He lives in Bangalore and delivers focused training sessions to IT professionals in Linux Kernel, Linux Debugging, Linux Device Drivers, Linux Networking, Linux Storage, Advanced C Programming, SAN Storage Technologies, SCSI Internals & Storage Protocols such as iSCSI & Fiber Channel. Stay connected with him @ LinkedIn