Category: Drug & Pharmaceutical Biotechnology Objective Questions

Pharmaceutical Biotechnology Questions and Answers for Experienced people on “Immunological Preparations – Classification of Vaccines”.

1. Who developed the first vaccine?
a) Pasteur
b) Salk
c) Jenner
d) Landsteiner

Answer: c
Clarification: Edward Jenner introduced small pox which was the first successful vaccine for smallpox in the year 1796. He injected cowpox virus into a boy and then he found out he has become immune to smallpox. That is how the smallpox vaccine was invented.

2. What causes smallpox?
a) Bacteria
b) Virus
c) Fungi
d) Protozoa

Answer: b
Clarification: Small pox was an infectious disease. It was caused by one or two variants of Variola major and Variola minor. It was a major disease in earlier days. But due to the invention of Edward Jenner and other recent developments, it was completely wiped out from the country.

3. Vaccines are used in all the forms, except _________
a) Live-attenuated vaccines
b) Inactivated vaccines
c) Subunit, recombinant, polysaccharide, and conjugate vaccines
d) Attenuated, inactivated, portions of protein, polysaccharides

Answer: d
Clarification: There are 3 main types of vaccine: live-attenuated vaccines; inactivated vaccines; and subunit, recombinant, polysaccharide, and conjugate vaccines. The vaccine is something which will activate the immune system up to the memory level. So that memory cells are produced in the body to protect from any further infection.

4. Which vaccine among these is used in its inactivated form?
a) Influenza
b) Measles
c) Mumps
d) Chickenpox

Answer: a
Clarification: Influenza vaccine is inactivated virus; measles, mumps, and chicken pox vaccines are live- attenuated viruses. Inactivated viruses are inactive to cause any diseases. They have their cell membrane proteins intact.

5. What is the key information required to develop a vaccine?
a) Molecular pathogenicity of the disease
b) Molecular pathogenicity of the disease-causing organism
c) Unique immunologic response from the host
d) Molecular pathogenicity of the disease and the disease-causing organism

Answer: d
Clarification: Key information required to develop a vaccine are: molecular pathogenicity of the disease or disease-causing organism (50%) and unique immunologic response from host (50%). The unique immunologic response from the host will decide the dosage form for the particular patient.

6. Who sets the rules for clinical trials?
a) NHS- National Health Service
b) NIH- National Institute of Health
c) NDA- New Drug Administration
d) FDA- Food and Drug Administration

Answer: d
Clarification: Food and Drug Administration (FDA) sets rules for the three phases of clinical trials to ensure the safety of the volunteers. Every researcher or manufacturer has to get a drug approved by the FDA. FDA sets rules for the manufacturing guidelines.

7. The BCG vaccine was developed by ___________ and ____________
a) Albert Calmette and Camille Guérin
b) Marry Currie and Perry Currie
c) Albert Einstein
d) Robert Hook

Answer: a
Clarification: The BCG vaccine was developed by French bacteriologists Albert Calmette and Camille Guérin. They named the vaccine or the product Bacillus Calmette-Guérin, or BCG.

8. A recombinant engineered vaccine is “direct manipulation of genes of weakened or killed pathogen for stimulating antibody production or cellular immunity against the pathogen but is incapable of causing severe infection”.
a) True
b) False

Answer: a
Clarification: A manipulation of genes of a weakened or killed pathogen, such as bacteria or virus that upon administration to a human body or any other animal will stimulate antibody production or cellular immunity against the pathogen. But this will be incapable of causing any severe disease or infection are known as recombinant engineered vaccines.

9. Recombinant engineered vaccines are being extensively explored to eradicate the following factors, except _________
a) Infectious diseases
b) Cancers
c) Allergies and cancers
d) Mental illness

Answer: d
Clarification: Recombinant engineered vaccines are being extensively explored, especially to eradicate infectious diseases, allergies, and cancers. Recombinant vaccines are manufactured by the recombinant DNA process. The vaccine will be able to provide immunogenicity to more diseases.

10. __________ demonstrated a plasmid-induced immune response using mice by inoculating with a plasmid expressing human growth hormone which elicited antibodies instead of faltering growth.
a) Stephen Johnston
b) Karry Mullis
c) Robert Hook
d) Alexander Fleming

Answer: a
Clarification: Stephen Johnston’s group saw that when mice are inoculated with plasmid DNA encoding human growth hormone, the mice is able to produce antibodies against this hormone. It was the first demonstration of a plasmid-induced immune response was when mice inoculated with a plasmid expressing human growth hormone elicited antibodies instead of faltering growth.

Pharmaceutical Biotechnology for Experienced people,

Tricky Drug Biotechnology Questions and Answers on “Physicochemical Factors Affecting Drug Absorption”.

1. Which one of the following is a critical rate-limiting step of drug absorption?
a) Rate of drug disintegration
b) Size of the drug
c) Size of the porous particle
d) Rate of dissolution
Answer: d
Clarification: For orally administered drug, the two critically slower rate determining step is the rate of dissolution and the rate of drug permeation. Dissolution is the rate determining stem for poorly aqueous soluble drugs and hydrophobic drugs.

2. Which sentence will define the Dissolution rate?
a) Amount of solid substrate that goes into solution under constant time
b) Amount of solid substrate that goes into solution under constant time under standard temperature
c) Amount of solid substrate that goes into solution under constant time under standard temperature, pH, and pressure
d) Amount of solid substrate that goes into solution under constant time under standard temperature, pH, solvent composition and constant surface area
Answer: d
Clarification: Dissolution rate is defined as the amount of solid substrate that goes into solution under constant time under standard temperature, pH, solvent composition and constant surface area. It is a dynamic process. Drugs having poor aqueous solubility have less dissolution rate.

3. What should be the ideal solubility rate of an orally administered drug in the pH range of 2 to 8?
a) 3-4mg/ml
b) 4-6 mg/ml
c) 7-8 mg/ml
d) 1-2 mg/ml
Answer: d
Clarification: The solubility of any orally administered drug should be between 1-2 mg/ml in the range of pH 2-8. The solubility becomes a great matter of concern if it is less than that. And if more than that the dosage must be carefully calculated.

4. Which one of these is not a theory of Drug dissolution?
a) Diffusion layer model
b) Fick’s law of diffusion
c) Penetration or surface renewal theory
d) Interfacial barrier model
Answer: b
Clarification: Fick’s law of diffusion states that drug molecules diffuse from higher concentration to lower concentration until equilibrium is reached. Theories of drug dissolution are Diffusion layer model or Fil theory, Danckwert’s model or Penetration or surface renewal theory, Interfacial barrier model or Double barrier theory.

5. Which theory takes into account that a thin film is created by the solution of the solid at the solid-liquid interface?
a) Interfacial barrier model
b) Diffusion layer model
c) Penetration or surface renewal theory
d) Danckwert’s model
Answer: b
Clarification: Diffusion layer model states that solution of a solid form a thin film or layer at the solid-liquid interface which is called as the stagnant film or diffusion layer which gets saturated with the drug. This step is rapid.

6. In the equation G=Ki (Cs-Cb), what does G stands for______________
a) Dissolution rate per unit area
b) Effective interfacial transport constant
c) Concentration of the solute
d) Concentration of the impurity
Answer: a
Clarification: According to the interfacial barrier model, an intermediate concentration exists at the interface which is a result of the solvation mechanism and is a function of solubility. Here in the equation G stands for dissolution rate per unit area, Ki stands for effective interfacial transport constant.

7. Which model does not approve the existence of the stagnant layer in the solid-liquid interface?
a) Interfacial barrier model
b) Diffusion layer model
c) Penetration or surface renewal theory
d) Danckwert’s model
Answer: d
Clarification: Danckwert did not approve the existence of the stagnant layer and suggested that turbulence in the dissolution medium exists at the solid/liquid interface. Due to which the agitated fluid consists of a macroscopic mass of eddies or packets reach the solid-liquid interface due to the eddy currents, absorb the solute by diffusion and carry it to the bulk of the solution.

8. What does the interfacial barrier model states?
a) An intermediate concentration exists at the interface
b) Turbulence in the dissolution medium exists at the solid/liquid interface
c) Formation a thin film or layer at the solid-liquid interface
d) Solutes passes easily through the interfaces
Answer: a
Clarification: An intermediate layer exist at the interface of the solid and liquid layers. This intermediate layer holds and intermediate concentration at the interface which results is solvation mechanism. The theory does not talk about any turbulence, or presence of solutes.

9. In the equation, Wo1/3-W1/3=Kt, K stands for ____________
a) The original mass of the drug
b) Mass of the drug remaining after time t
c) Dissolution constant
d) Concentration of solute
Answer: c
Clarification: To calculate the particle size decrease and change in the surface area of the dissolution Hixson and Crowell’s cubit root law of dissolution is followed, Wo1/3-W1/3=Kt, where, Wo stands for original mass of the drug, W stands for the mass of the drug remaining after time t, K stands for dissolution constant.

10. Which are the two rate-determining step of drug absorption when given orally?
a) Disintegration and deaggregation
b) Disintegration and Dissolution
c) Dissolution and permeation through the membrane
d) Permeation through the membrane and Disintegration
Answer: c
Clarification: The two critical slower rate-determining processes in the absorption of orally administered drugs are the rate of dissolution and rate of the solute or the drug permeation through the cell membrane or biomembrane.

11. The maximum amount of solute dissolved in a given solvent under standard conditions of temperature, pressure, and pH is known as __________
a) Dissolution rate
b) Intrinsic dissolution
c) Rate limiting step
d) Absolute or intrinsic solubility
Answer: d
Clarification: Absolute or intrinsic solubility is defined as the maximum amount of solute dissolved in a given solvent under standard conditions of temperature, pressure, and pH. It is a static property. Dissolution rate is the amount of a solid substance that dissolves into solution under given conditions.

12. In the equation, V dC/dt = dm/dt = A(Cs-Cb).√ γ D, what does γ stands for?
a) Mass of the solid dissolved
b) Rate of surface renewal
c) Concentration of solute
d) Concentration of the drug
Answer: b
Clarification: The Danckwert’s model is expressed by the equation, V dC/dt = dm/dt = A (Cs-Cb).√ γ D, where γ is the rate of surface renewal, m is the mass of solid dissolved. Cs concentration of the solute.

13. Each face of the crystal has a different interfacial barrier.
a) True
b) False
Answer: a
Clarification: The statement is true. According to the interfacial barrier model, each face of a crystal has a different interfacial barrier. This concept is given by G=Ki (Cs-Cb).

To practice Tricky questions and answers on all areas of Drug Biotechnology,

Drug Biotechnology Questions and Answers for Experienced people on “Drugs Biotransformation – Phase 1 Reactions – 2”.

1. Which one is the rate-limiting step in the oxidation of xenobiotics?
a) Binding of the substrate to Fe³⁺
b) Electron transfer from NADPH to the above complex
c) The enzyme-substrate complex combines with a molecule of oxygen forming a ternary complex
d) Ternary complex gains an electron from the NADPH
Answer: b
Clarification: The rate-limiting step is the transfer of an electron from NADPH to the complex of substrate and cytochrome 450. The gaining of an electron by cytochrome 450 reduces the Fe³⁺ to Fe²⁺. This step is considered the rate-limiting step of the oxidation of xenobiotics.

2. What provides the atom of oxygen for the making of water?
a) From the cytochrome 450
b) From the environment
c) From the activated oxygen P-450 substrate complex
d) From cytochrome reductase
Answer: c
Clarification: One atom of oxygen from the activated oxygen P450 complex is transferred to the substrate to yield the oxidized product and the other atom forms water. The free oxidized form of cytochrome P-450 is ready to attach to another molecule of substrate.

3. What is the major end product of oxidation of aromatic carbon atoms?
a) Arenols
b) Catechol
c) Glutathione
d) Arene oxide
Answer: a
Clarification: The oxidation of aromatic carbon atoms proceeds via formation of a reactive intermediate arene oxide. This arene oxide in most cases is converted into arenols and in some cases produces minor products such as catechols and glutathione conjugates.

4. Which one of the following is reactive and a known carcinogenic?
a) Cytochrome P-450
b) Catechol
c) Glutathione
d) Arene oxide
Answer: d
Clarification: The oxidation of aromatic carbon atoms proceeds via formation of a reactive intermediate arene oxide. This arene oxide is a known carcinogenic or even cytotoxic in some instances.

5. Which of the following is not a common N containing functional groups which undergo reduction reactions?
a) Nitro compounds
b) Azo compounds
c) N-oxide compounds
d) Nitrite compounds
Answer: d
Clarification: The N-containing functional groups that commonly undergo bioreduction are nitro, azo, N-oxide compounds. Reduction of the nitro group proceeds via formation of nitroso and hydroxylamine intermediates to yield amines.

6. Esters on hydrolysis yields alcohol and carboxylic acid.
a) True
b) False
Answer: a
Clarification: Esters on hydrolysis yield alcohol and carboxylic acids with the release of a water molecule. The reaction is catalysed by esterase.

7. Which enzymes catalyses the hydrolysis of amides?
a) Esterase
b) Amydases
c) Amidases
d) Aminodases
Answer: c
Clarification: The reaction of hydrolysis of amides is catalysed by amidases. The reaction involves C-N bond cleavage thus yielding carboxylic acid and amine. Amides are hydrolysed slowly in comparison to esters.

8. What is the end product of hydrolysis of Lidocaine?
a) 2, 6-Xylidine, N, N-Dimethylglycine
b) 2, 5- Xylidine, Dimethylglycine
c) Xylidine, glycine
d) 1, 6-Xylidine
Answer: a
Clarification: The reaction of hydrolysis of amides is catalysed by amidases. Lidocaine is a secondary amide with an organic substituent on N-atom. Thus providing us with 2, 6-Xylidine, N, N-Dimethylglycine as the end product.

9. What is the end product of hydrolytic dehalogenation of DDT?
a) Dichloro diphenyl ethylene
b) 1- chloro diphenyl dichloroethylene
c) Trichloro triphenyl trichloroethylene
d) Dichloro diphenyl dichloroethylene
Answer: d
Clarification: In the hydrolytic dehalogenation a molecule of HCL is removed from the substrate. Thus in the case of Dichloro diphenyl trichloroethane when a molecule of HCL is removed we get Dichloro diphenyl dichloroethylene as the product.

10. What does the hydrolysis of Aspirin yield us with?
a) Salicylic acid only
b) Salicylic acid and CH₃COOH
c) CH₃COOH
d) Succinic acid
Answer: b
Clarification: Esters like aspirin with large alcoholic and small acidic group when hydrolysed in the presence of esterase yields us with salicylic acid and CH₃COOH as the end product.

Drug Biotechnology for Experienced people,

Drug Biotechnology Questions and Answers for Aptitude test on “Bioavailability – Methods for Enhancement”.

1. Poor bioavailability means poor aqueous solubility.
a) True
b) False
Answer: a
Clarification: A drug with poor bioavailability means the drug can also have poor aqueous solubility, slow dissolution rate in plasma or other biological fluids. The drug can also have poor stability of the dissolved drug at the patient’s body pH, inadequate partition coefficient, and extensive presystemic metabolism.

2. A drug with poor stability means higher bioavailability.
a) True
b) False
Answer: b
Clarification: Poor stability of the drug at physiological pH causes the difference in its disintegration, dissolution rate thus decreasing the bioavailability. The drug can also have poor stability of the dissolved drug at the patient’s body pH, inadequate partition coefficient, and extensive presystemic metabolism.

3. Which of the following is not an approach for overcoming bioavailability problems?
a) Pharmaceutic approach
b) Pharmacokinetic approach
c) Biologic approach
d) Partition coefficient approach
Answer: d
Clarification: There are three approaches in overcoming the bioavailability problems these are the pharmaceutic approach, pharmacokinetic approach, and biologic approach. The pharmaceutic approach involves modification of formulation, manufacturing processes. The pharmacokinetic approach is in which the pharmacokinetics of the drug is altered by modifying its chemical structure. The biologic approach is where the route of administration can be changed.

4. What will be the particle size after micronization of drugs?
a) 1-10 micron
b) 10-20 micron
c) 20-30 micron
d) 1-5 micron
Answer: a
Clarification: Micronization is a process where the size of the solid drug particles is reduced to 1-10 microns by spray drying or by using air attrition methods. Drugs such as griseofulvin and several steroidal and sulfa drugs are there whose bioavailability is increased by micronization.

5. What is the principle behind the use of surfactants?
a) Reducing the size of solid drug particles
b) Enhancing the dissolution rate by promoting wetting
c) Improving solubility
d) Alter the pH of the microenvironment
Answer: b
Clarification: Surfactants enhance the dissolution rate by promoting wetting and penetration of dissolution fluid into the solid drug particles. These surfactants are used in a concentration below the critical micellar concentration since above CMC the trapped drug in the micelle structure fails to partition in the dissolution fluid.

6. Salts improve solubility and dissolution characteristics.
a) True
b) False
Answer: a
Clarification: Salts improve solubility and dissolution property of the drug in comparison to the original characteristic. Alkali metal salts of acidic drugs and strong acidic salt of the basic drug are more water soluble than the parent drug. For example penicillin and atropine respectively.

7. How pH alteration of the drug microenvironment is done?
a) Altering the pH while the administration
b) In situ salt formation
c) Altering the pH of the tissue
d) Formulating the drug in such a way that it gets activated only when it reaches the tissue pH
Answer: b
Clarification: Alteration of pH of the drug microenvironment is done in two ways. One of that is in-situ salt formation, and other is the addition of buffers to the formulation e.g. buffered aspirin tablets. We cannot depend on tissue pH since it changes person to person.

8. Which one of the following is used for selective adsorption on insoluble carriers of the drugs?
a) Freeze drying
b) Organic solvent
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: c
Clarification: In the process of selective adsorption on insoluble carriers a highly active adsorbent as the inorganic clays like bentonite can enhance the dissolution rate of poorly aqueous soluble drugs such as indomethacin, it maintains the concentration gradient at its maximum.

9. Which of the following is used in the solvent deposition method of enhancing bioavailability?
a) Freeze drying
b) Organic solvent
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: b
Clarification: Insolvent deposition method, poorly aqueous soluble drugs are dissolved in an organic solvent such as alcohol and deposited on an inert, hydrophilic, solid matrix such as that of starch or microcrystalline cellulose by evaporation of the solvent.

10. Which of the following is used in solid solutions method of enhancing bioavailability?
a) Highly water-soluble compound
b) Organic solvent
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: a
Clarification: There are three different ways of solid solutions these are the use of the solid solution, use of eutectic mixtures, and the use of solid dispersions. In all these cases the solute or the drug is most of the times not soluble in water acts as a guest and the solvent used is highly water-soluble compound or polymer acting as a host or carrier.

11. In the below picture which form of solid solution of griseofulvin with succinic acid is shown?

a) Solid solution
b) Eutectic mixture
c) Micronized drug
d) Coarse drug
Answer: a
Clarification: Solid solutions are prepared by fusion method where a mixture of solute and solvent are melted together followed by rapid solidification. Such systems are prepared by fusion and are called as melts e.g. griseofulvin-succinic acid. Solid solution is binary system with solid solute dispersed in solid solvent. Eutectic mixtures are physically blended mixture of two crystalline compound.

12. In the below picture which form of solid solution of griseofulvin with succinic acid is shown?

a) Solid solution
b) Eutectic mixture
c) Micronized drug
d) Coarse drug
Answer: b
Clarification: Solid solutions are prepared by fusion method where a mixture of solute and solvent are melted together followed by rapid solidification. Such systems are prepared by fusion and are called as melts e.g. griseofulvin-succinic acid. Solid solution is binary system with solid solute dispersed in solid solvent. Eutectic mixtures are physically blended mixture of two crystalline compound.

13. In the below picture which form of solid solution of griseofulvin with succinic acid is shown?

a) Solid solution
b) Eutectic mixture
c) Micronized drug
d) Coarse drug
Answer: c
Clarification: Solid solutions are prepared by fusion method where a mixture of solute and solvent are melted together followed by rapid solidification. Such systems are prepared by fusion and are called as melts e.g. griseofulvin-succinic acid. Solid solution is binary system with solid solute dispersed in solid solvent. Eutectic mixtures are physically blended mixture of two crystalline compound.

14. In the below picture which form of solid solution of griseofulvin with succinic acid is shown?

a) Solid solution
b) Eutectic mixture
c) Micronized drug
d) Coarse drug
Answer: d
Clarification: Solid solutions are prepared by fusion method where a mixture of solute and solvent are melted together followed by rapid solidification. Such systems are prepared by fusion and are called as melts e.g. griseofulvin-succinic acid. A solid solution is a binary system with solid solute dispersed in a solid solvent. Eutectic mixtures are physically blended mixture of two crystalline compounds.

15. Which of the following is used in molecular encapsulation of drugs for enhancing bioavailability?
a) Highly water-soluble compound
b) Cyclodextrin
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: b
Clarification: Beta and gamma Cyclodextrin and other derivatives have the ability to form molecular inclusion complexes with hydrophobic drugs having poor aqueous solubility. These Cyclodextrin molecules have a hydrophobic cavity which can accommodate the lipophilic drugs as a guest. The outside of which is hydrophilic.

Drug Biotechnology for Aptitude test,

Drug Biotechnology online quiz 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
Answer: b
Clarification: 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.

2. In which phase pharmacodynamics and pharmacokinetics of a drug are studied?
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer: a
Clarification: 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
Answer: b
Clarification: 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
Answer: a
Clarification: 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
Answer: c
Clarification: 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
Answer: d
Clarification: 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.

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
Answer: a
Clarification: 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
Answer: b
Clarification: 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
Answer: a
Clarification: 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
Answer: b
Clarification: 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
Answer: d
Clarification: 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
Answer: c
Clarification: 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.

13. What is the full form of IND?
a) Investigated drug
b) Investigation Application
c) Investigation of New Drug Application
d) Under Investigation
Answer: c
Clarification: 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
Answer: c
Clarification: 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
Answer: a
Clarification: 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.

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