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DDD - FINALS (3C)

Total questions: 100

Worksheet time: 3hrs 54mins

Name
Class
Date
1.

This is the study of protein activity within a given cell, tissue or organism.

a)

biotechnology

b)

proteomics

c)

pharmacogenomics

d)

biopharmaceutics

2.

A technology which allows people to use the digital resources stored in the virtual space by way of networks which is often satellite networks. It allows people to share information and applications across the internet without being the restriction of their physical location.

a)

targeting RNA with small molecules

b)

cloud technology

c)

phenotypic screening

d)

3D printing

3.

This process in drug discovery is used to recognize hits from compound libraries that may become a lead compound.

a)

High-throughput Screening

b)

Phenotypic screening

c)

3D bioprinting

d)

Bioinks

4.

Drug design that relies on knowledge of the three dimensional structure of the biological target obtained through NMR.

a)

Structure-based drug design

b)

Ligand-based drug design

5.

Netflix

a)

Public Cloud

b)

Private Cloud

c)

Hybrid Cloud

d)

Community Cloud

6.

Sensory

a)

Flow

b)

Organoleptic

c)

Polymorphism

d)

Pka

7.

Photolysis

a)

Chemical properties

b)

Physical properties

8.

Thermal effect

a)

Chemical properties

b)

Physical properties

9.

Ksp

a)

Chemical properties

b)

Physical properties

10.

Isomerization

a)

Chemical properties

b)

Physical properties

11.

Stability analysis

a)

Chemical properties

b)

Physical properties

12.

This is a chemical reaction in which an organic or inorganic chemical is broken down by photons and is the interaction of one or more photons with one target molecule.

a)

Racemization

b)

Photolysis

c)

Isomerization

d)

Polymerization

13.

It is a process wherein optically active compounds (which consist of only one enantiomer) are converted into an equal mixture of enantiomers with zero optical activity.

a)

Racemization

b)

Photolysis

c)

Isomerization

d)

Polymerization

14.

This the process of connecting small molecules together and forming larger ones.

a)

Racemization

b)

Photolysis

c)

Isomerization

d)

Polymerization

15.

The process of converting a molecule into its isomers.

a)

Racemization

b)

Photolysis

c)

Isomerization

d)

Polymerization

16.

These are designed to deliver all necessary data especially physicochemical, physico-mechanical and biopharmaceutical properties of drug substances, excipients and packaging materials.

a)

Preclinical Phase

b)

Pre-formulation

c)

Phase I CT

d)

Phase II CT

17.

"druggability" assessment

a)

Preclinical Phase

b)

Pre-formulation

c)

Phase I CT

d)

Phase II CT

18.

First step in rational development of a dosage form of a drug substance before dosage form development.

a)

Preclinical Phase

b)

Pre-formulation

c)

Phase I CT

d)

Phase II CT

19.

Toxicity Studies

a)

Preclinical Phase

b)

Pre-formulation

c)

Phase I CT

d)

Phase II CT

20.

I-cloud

a)

Public cloud

b)

Private cloud

c)

Hybrid cloud

d)

Community cloud

21.

Patient-centric and value based medicines

a)

precision medicine

b)

traditional medicine

22.

Ethical Conduct in the Care and Use of Animals

a)

Preclinical Phase

b)

Pre-formulation

c)

Phase I CT

d)

Phase II CT

23.

Obtaining new information about the drug under trial could affect the willingness of research participants to continue to participate.

a)

TRUE

b)

FALSE

24.

The researcher shall voluntarily obtain a waiver of the prospective research participant.

a)

TRUE

b)

FALSE

25.

Transparency is diametrically opposed to privacy.

a)

TRUE

b)

FALSE

26.

All procedures shall be satisfactorily described in detail only for researches having invasive methods of obtaining data.

a)

TRUE

b)

FALSE

27.

If the findings for laboratory tests are successful, the researchers will submit the gathered data to the governing body which is the WHO for approval to continue research and testing in humans.

a)

TRUE

b)

FALSE

28.

Depending on the purpose of the trial, patients in the control group get no treatment, a placebo (an inactive product resembling the investigational drug), another drug known to be effective or a different dose of the drug under study

a)

BLINDING

b)

RANDOMIZATION

c)

CONTROLLED CT

29.

Patients, investigators and data analysts do not know which patients received the investigational drug.

a)

BLINDING

b)

RANDOMIZATION

c)

CONTROLLED CT

30.

Drug class system: Already marketed drug product – marketed by other firm

a)

Type 1

b)

Type 2

c)

Type 3

d)

Type 4

e)

Type 5

31.

Drug class system: New combination

a)

Type 1

b)

Type 2

c)

Type 3

d)

Type 4

e)

Type 5

32.

Drug class system: New salt

a)

Type 1

b)

Type 2

c)

Type 3

d)

Type 4

e)

Type 5

33.

20-100 healthy participants

a)

PHASE I

b)

PHASE II

c)

PHASE III

d)

PHASE IV

e)

PHASE V

34.

These studies are intended to determine, by ascending doses, the multiple dose drug level required for a therapeutic response.

a)

PHASE I

b)

PHASE II

c)

PHASE III

d)

PHASE IV

e)

PHASE V

35.

1000-3000 healthy participants

a)

PHASE I

b)

PHASE II

c)

PHASE III

d)

PHASE IV

e)

PHASE V

36.

This phase provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions

a)

PHASE I

b)

PHASE II

c)

PHASE III

d)

PHASE IV

e)

PHASE V

37.

A biomarker accepted by the FDA

a)

surrogate endpoint

b)

biomarkers

c)

ECGs

d)

Lab tests

38.

This phase aims to monitor a drug's long-term effectiveness and impact on a patient's quality of life

a)

PHASE I

b)

PHASE II

c)

PHASE III

d)

PHASE IV

39.

control and handling of investigational drug

a)

SPONSORS

b)

INVESTIGATORS

40.

Review of ongoing investigations

a)

SPONSORS

b)

INVESTIGATORS

41.

Assurance of IRB review

a)

SPONSORS

b)

INVESTIGATORS

42.

These are substances, often proteins, that can be used for measuring a biological function, identifying a disease process, or determining responses to a therapy. They also can be used for diagnosis, for prognosis, and for guiding treatment.

a)

Biomarkers

b)

Surrogate endpoint

c)

Lab tests

d)

ECG

43.

A process that combines living cells and biomaterials

a)

targeting RNA with small molecules

b)

cloud technology

c)

phenotypic screening

d)

3D printing

44.

It is an on-demand technology where users utilize the IT resources over the internet platform and work on a pay-per-use mechanism instead of the previous subscription based technologies.

a)

targeting RNA with small molecules

b)

cloud technology

c)

phenotypic screening

d)

3D printing

45.

Large scale 3D bioprinting

a)

Inkjet printing

b)

Extrusion printing

c)

Lase-assisted printing

46.

High resolution 3D printing

a)

Inkjet printing

b)

Extrusion printing

c)

Laser-assisted printing

47.

Which of the following is correct with regards to bioprinting?

a)

Process of creating cell patterns

b)

Can produce living tissue, bone and skin

c)

Layer by layer

d)

AOTA

48.

An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.

a)

Precision medicine

b)

Biotechnology

c)

Traditional medicine

d)

Cloud technology

49.

Treatment and prevention strategies are developed with less consideration for the differences between individuals.

a)

Precision medicine

b)

Biotechnology

c)

Traditional medicine

d)

Cloud technology

50.

Transderm-scop

a)

Inhaled insulin

b)

TDDS

c)

Intravenous

d)

Implant

51.

Animal models and cell-based assays are both strategies used to identify these molecules. These allow direct screening of compounds in preclinical disease models

a)

Targeting RNA with small molecules

b)

Cloud technology

c)

Phenotypic screening

d)

3D printing

52.

Drugs under Solidarity Trial against COVID 19 and its approved indications, select among the following choices that is not correct:

A. Remdesivir - Antiviral

B. Chloroquine/Hydroxychloroquine - Antimalarial

C. Lopinavir w/ Ritonavir - Antiretroviral used as treatment for HIV

D. Lopinavir with Ritonavir plus Interferon beta-1a • Lopinavir w/ Ritonavir - Antiretroviral used as treatment for HIV • Interferon beta-1a – treatment. for multiple sclerosis

E. Dexamethasone- anti- inflammatory

a)

A, B, C

b)

B and C

c)

all are correct

d)

E

53.

These are microfluidic devices lined with living human cells for drug development, disease modeling and personalized medicine.

a)

phenotypic screening

b)

novel dosage form

c)

organ on a chip

d)

Bioprint

54.

In the analytical profiling of the compound under drug discovery, the structural characterization can be performed by the following:

A. IR

B. AAS

C. NMR

D. XRD

E. HPLC

a)

A, C and D

b)

B, D and E

c)

A, C and E

d)

all of the choices

55.

Physical characterization of the new moiety includes;

A. solubility

B. morphology

C. Hygroscopicity

D. Partition coefficient

E. Stability

a)

A, B and C

b)

A, B and E

c)

B, C and D

d)

AOTA

56.

Which is not properly labeled with its RA numbers

a)

Republic Act No. 8298 - Intellectual Property Code of the Philippines

b)

Republic Act No. 8485 – Animal Welfare Act

c)

Republic Act No. 10173 – Data Privacy Act of 2012

57.

For the duration of intellectual property rights, which is not true among the choices:

a)

Patent- 20 years and cannot be renewed

b)

Trademarks- 10 years but renewable every 10 years

c)

Utility model – 6 to 10 years

d)

Copyright – life of author plus 50 years

58.

This deals that new discovery is to choose the compounds with a known pharmacological action and proceed to modify the molecular structure of the compound systemically to get a drug with desired properties pharmacological action and pharmacokinetics.

a)

Biomarking

b)

Lead target technique

c)

Biotechnology

d)

Lead Optimization technique

59.

The study of the botanical origin of the arrow poison curare, its physiological effects and the compound responsible for its effects. Curare was used by certain wild tribes in South America for poisoning their arrows. This is an example of:

a)

ethnobotany

b)

ethnopharmacology

c)

natural product research

d)

biotechnology

60.

A type of drug receptor which follows the lock and key model:

a)

ligand gated receptor

b)

NZ linked receptor

c)

G protein coupled receptor

d)

intracellular receptor

61.

Which does not correctly describe red biotechnology?

a)

It involves the manipulation of microorganisms to make products

b)

also called industrial biotechnology

c)

used in medical processes

d)

Use in forensic through DNA profiling

62.

Which of the following incorrectly describes the advantages of Intellectual Property Rights?

a)

Provides exclusive rights to the creators or inventors in all countries

b)

Encourages individuals to distribute and share information and data instead of keeping it confidential.

c)

Provides legal defense and offers the creators the incentive of their work.

d)

Helps in social and financial development.

63.

Bioequivalence testing is the only clinical trial requirement for Abbreviated New Drug Application (ANDA).

a)

TRUE

b)

FALSE

64.

In a tablet formulation where active ingredient is mefenamic acid, one formulation contains the excipient starch while the other formulation contains PEG. If these formulations differ in the use of excipients with that of innovator drug, can these 2 formulations qualify to apply for ANDA?

a)

YES

b)

NO

65.

It is a process of communication between you and your health care provider that often leads to agreement or permission for care, treatment, or services. Every patient has the right to get information and ask questions before procedures and treatments.

a)

informed consent

b)

autonomy

c)

clinical trial

d)

protocol

66.

On Clinical trial, which does not correctly describe the phase:

a)

Phase 1 – efficacy with 20-100 participants

b)

Phase 2 – safety and efficacy with 100-300 participants

c)

Phase 3 – safety and efficacy with 1,000-3,00 participants

d)

Phase 4 – FDA review

67.

This refers to individualized treatment that uses new diagnostics and therapeutics. It targets to the need of a patient based on own genetic, biomarker, phenotypic or psychosocial characteristics.

a)

Precision medicine

b)

Biotechnology

c)

Traditional medicine

d)

Cloud technology

68.

A specific antibiotic which targets ribosomal RNA.

a)

Neomycin

b)

Cefalexin

c)

Tigacycline

d)

Streptomycin

69.

Randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response. This type of trial is under.

a)

Phase I

b)

Phase II

c)

Phase III

d)

Phase IV

70.

Normally, patients in Phase II studies will not be exposed to the highest drug level reached for more than 2 weeks. However, it is possible for Phase II patients to carry over into Phase III studies for longer terms.

a)

TRUE

b)

FALSE

71.

Objectives of this phase are the following:


(1) to compare a drug with other drugs already in the market;

(2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and

(3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies

a)

A. Phase 3

b)

B. Phase 4

c)

C. PMS

d)

B and C

72.

The International Conference on Harmonization (ICH) has the following goals, except:

a)

Make new drugs available with minimum delay

b)

Produce drugs that are affordable

c)

Minimize unnecessary duplicate testing during the research and development

d)

Develop guidance documents that create consistency in the requirements

73.

The trademark protection granted by IP Philippines protects the mark also outside the country.

a)

TRUE

b)

FALSE

74.

The type of animal toxicity testing where its effects are observed for 28 days.

a)

Acute

b)

Sub-acute

c)

Chronic

d)

Sub-chronic

75.

A dose which is considered high enough that if no mortality/significant toxicity is seen in animals receiving this dose, no higher doses are required.

a)

Maximum Tolerated Dose

b)

Highest Dose Tested

c)

Limit Dose

d)

Acute Dose

76.

LD10 means:

a)

the dose that causes 10% effectivity in a population

b)

the dose that causes 10% mortality in a population

c)

median lethal dose

d)

median lethal concentration

77.

The 1st 3D printed drug approved by FDA

a)

Spritam

b)

Zipdose

c)

Aprecia

78.

A type of drug receptor which is targeted structure base:

a)

ligand gated receptor

b)

NZ linked receptor

c)

G protein coupled receptor

d)

intracellular receptor

79.

It is a patent-like intellectual property right to protect inventions. it is generally cheaper to obtain and maintain, has a shorter term, shorter grant lag, and less stringent patentability requirements.

a)

Trademark

b)

Utility model

c)

Copyright

d)

Industrial design

80.

Afrezza

a)

Inhaled insulin

b)

Insulin patch

c)

Insulin IV

d)

Insulin SQ

81.

Under this law, drugs developed for rare diseases gain seven years of additional exclusivity on drug sales, and the FDA is blocked from approving any competing generics during this time.

a)

Orphan drug act

b)

Hatch-waxman act

c)

Data privacy act

d)

IP code

82.

Last Resort Drug for MRSA

a)

Linezolid

b)

Vancomycin

c)

Corbomycin

d)

Tigecycline

83.

It is a microfluidic chip reproducing the mechanisms of a heart, in order to test medicine quickly and observe the reaction of heart cells.

a)

cardio-on-chip

b)

heart-on-chip

c)

lungs-on-chip

84.

This process delivers information on the effect of a bioactive compound directly on an advanced disease-relevant parameter.

a)

targeting RNA with small molecules

b)

cloud technology

c)

phenotypic screening

d)

3D printing

85.

These are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply.

a)

antibiotics

b)

antifungals

c)

antivirals

86.

This test is used as an alternative to the guinea pig Draize test, and it is widely accepted that this method meets regulatory requirements. The test substance is applied on the surface of the ears of a mouse for three consecutive days, and the proliferation of lymphocytes in the draining lymph node is measured at the end.

a)

Murine local lymph node assay

b)

Guinea pig maximization test

c)

Buehler test

d)

Split adjuvant test

87.

The test animal used for skin sensitization test (Select all that may apply)

a)

Guinea pig

b)

Rabbit

c)

Mice

d)

Rat

88.

Rules and Regulations on the Conduct of Scientific Procedures Using Animals

a)

D.A. A.O. No. 40

b)

D.A. A.O. No. 04

89.

This refers to the relevance of the study to an existing social or health problem such that the results are expected to bring about a better understanding of related issues, or contribute to the promotion of well-being of individuals, their families, and communities.

a)

Social value

b)

Autonomy

c)

Informed Consent

d)

Protocols

90.

Taxus brevifolia

a)

Anti-cancer

b)

Anti-viral

c)

Anti-fungal

d)

Anti-bacterial

91.

Multi component analysis of plant extracts can already be performed using the following analytical tools, except:

a)

AAA

b)

NMR

c)

GC

d)

MS

92.

Which is in right order/sequence?

a)

target- lead optimization- lead identification-preformulation

b)

target- lead identification - lead optimization- preformulation

93.

A pre-formulation parameter for stable storage conditions, how the quality of a drug substance or product varies over a given time period and under the influence of environmental factors including temperature, humidity and light.

a)

Stability

b)

Thermal effect

c)

Solubility

d)

Common Ion Effect

94.

The degree of crystallinity has a big influence on hardness, density, transparency and diffusion.

a)

True

b)

False

95.

Animal Toxicity Tests duration of study, which is/are incorrect:


(SELECT ALL THAT APPLY)

a)

acute – 14 days

b)

sub-acute – 28 days

c)

chronic – 3 months

d)

sub-chronic – 3 months or more

96.

Gold standard statistical procedure:

a)

RCT

b)

Blinding

c)

Split Person Design

97.

A Filipino author of a book on Drug Discovery Development allowed C and E to publish his/her work. Concurrently the author can also file for what type of intellectual property right:

a)

TRADE SECRET

b)

COPYRIGHT

c)

PATENT

d)

TRADEMARK

98.

The office which is responsible for the processing of applications for patent.

a)

IPOPHIL

b)

NATIONAL LIBRARY

c)

SUPREME COURT

d)

PATENT OFFICE

99.

The International Conference on Harmonization (ICH) brought together government regulators and drug industry representatives from the following countries to make the international drug regulatory process more efficient and uniform, except:

a)

KOREA

b)

JAPAN

c)

US

d)

EUROPE

100.

Advantages of Intellectual Property Rights, except.

a)

provides exclusive rights to creators or inventors

b)

can be enjoyed throughout the authors lifetime

c)

helps in social and financial development

d)

provides incentives of their work