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WorksheetsDDD - FINALS (3C)
Total questions: 100
Worksheet time: 3hrs 54mins
This is the study of protein activity within a given cell, tissue or organism.
biotechnology
proteomics
pharmacogenomics
biopharmaceutics
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.
targeting RNA with small molecules
cloud technology
phenotypic screening
3D printing
This process in drug discovery is used to recognize hits from compound libraries that may become a lead compound.
High-throughput Screening
Phenotypic screening
3D bioprinting
Bioinks
Drug design that relies on knowledge of the three dimensional structure of the biological target obtained through NMR.
Structure-based drug design
Ligand-based drug design
Netflix
Public Cloud
Private Cloud
Hybrid Cloud
Community Cloud
Sensory
Flow
Organoleptic
Polymorphism
Pka
Photolysis
Chemical properties
Physical properties
Thermal effect
Chemical properties
Physical properties
Ksp
Chemical properties
Physical properties
Isomerization
Chemical properties
Physical properties
Stability analysis
Chemical properties
Physical properties
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.
Racemization
Photolysis
Isomerization
Polymerization
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.
Racemization
Photolysis
Isomerization
Polymerization
This the process of connecting small molecules together and forming larger ones.
Racemization
Photolysis
Isomerization
Polymerization
The process of converting a molecule into its isomers.
Racemization
Photolysis
Isomerization
Polymerization
These are designed to deliver all necessary data especially physicochemical, physico-mechanical and biopharmaceutical properties of drug substances, excipients and packaging materials.
Preclinical Phase
Pre-formulation
Phase I CT
Phase II CT
"druggability" assessment
Preclinical Phase
Pre-formulation
Phase I CT
Phase II CT
First step in rational development of a dosage form of a drug substance before dosage form development.
Preclinical Phase
Pre-formulation
Phase I CT
Phase II CT
Toxicity Studies
Preclinical Phase
Pre-formulation
Phase I CT
Phase II CT
I-cloud
Public cloud
Private cloud
Hybrid cloud
Community cloud
Patient-centric and value based medicines
precision medicine
traditional medicine
Ethical Conduct in the Care and Use of Animals
Preclinical Phase
Pre-formulation
Phase I CT
Phase II CT
Obtaining new information about the drug under trial could affect the willingness of research participants to continue to participate.
TRUE
FALSE
The researcher shall voluntarily obtain a waiver of the prospective research participant.
TRUE
FALSE
Transparency is diametrically opposed to privacy.
TRUE
FALSE
All procedures shall be satisfactorily described in detail only for researches having invasive methods of obtaining data.
TRUE
FALSE
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.
TRUE
FALSE
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
BLINDING
RANDOMIZATION
CONTROLLED CT
Patients, investigators and data analysts do not know which patients received the investigational drug.
BLINDING
RANDOMIZATION
CONTROLLED CT
Drug class system: Already marketed drug product – marketed by other firm
Type 1
Type 2
Type 3
Type 4
Type 5
Drug class system: New combination
Type 1
Type 2
Type 3
Type 4
Type 5
Drug class system: New salt
Type 1
Type 2
Type 3
Type 4
Type 5
20-100 healthy participants
PHASE I
PHASE II
PHASE III
PHASE IV
PHASE V
These studies are intended to determine, by ascending doses, the multiple dose drug level required for a therapeutic response.
PHASE I
PHASE II
PHASE III
PHASE IV
PHASE V
1000-3000 healthy participants
PHASE I
PHASE II
PHASE III
PHASE IV
PHASE V
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
PHASE I
PHASE II
PHASE III
PHASE IV
PHASE V
A biomarker accepted by the FDA
surrogate endpoint
biomarkers
ECGs
Lab tests
This phase aims to monitor a drug's long-term effectiveness and impact on a patient's quality of life
PHASE I
PHASE II
PHASE III
PHASE IV
control and handling of investigational drug
SPONSORS
INVESTIGATORS
Review of ongoing investigations
SPONSORS
INVESTIGATORS
Assurance of IRB review
SPONSORS
INVESTIGATORS
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.
Biomarkers
Surrogate endpoint
Lab tests
ECG
A process that combines living cells and biomaterials
targeting RNA with small molecules
cloud technology
phenotypic screening
3D printing
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.
targeting RNA with small molecules
cloud technology
phenotypic screening
3D printing
Large scale 3D bioprinting
Inkjet printing
Extrusion printing
Lase-assisted printing
High resolution 3D printing
Inkjet printing
Extrusion printing
Laser-assisted printing
Which of the following is correct with regards to bioprinting?
Process of creating cell patterns
Can produce living tissue, bone and skin
Layer by layer
AOTA
An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.
Precision medicine
Biotechnology
Traditional medicine
Cloud technology
Treatment and prevention strategies are developed with less consideration for the differences between individuals.
Precision medicine
Biotechnology
Traditional medicine
Cloud technology
Transderm-scop
Inhaled insulin
TDDS
Intravenous
Implant
Animal models and cell-based assays are both strategies used to identify these molecules. These allow direct screening of compounds in preclinical disease models
Targeting RNA with small molecules
Cloud technology
Phenotypic screening
3D printing
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, B, C
B and C
all are correct
E
These are microfluidic devices lined with living human cells for drug development, disease modeling and personalized medicine.
phenotypic screening
novel dosage form
organ on a chip
Bioprint
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, C and D
B, D and E
A, C and E
all of the choices
Physical characterization of the new moiety includes;
A. solubility
B. morphology
C. Hygroscopicity
D. Partition coefficient
E. Stability
A, B and C
A, B and E
B, C and D
AOTA
Which is not properly labeled with its RA numbers
Republic Act No. 8298 - Intellectual Property Code of the Philippines
Republic Act No. 8485 – Animal Welfare Act
Republic Act No. 10173 – Data Privacy Act of 2012
For the duration of intellectual property rights, which is not true among the choices:
Patent- 20 years and cannot be renewed
Trademarks- 10 years but renewable every 10 years
Utility model – 6 to 10 years
Copyright – life of author plus 50 years
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.
Biomarking
Lead target technique
Biotechnology
Lead Optimization technique
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:
ethnobotany
ethnopharmacology
natural product research
biotechnology
A type of drug receptor which follows the lock and key model:
ligand gated receptor
NZ linked receptor
G protein coupled receptor
intracellular receptor
Which does not correctly describe red biotechnology?
It involves the manipulation of microorganisms to make products
also called industrial biotechnology
used in medical processes
Use in forensic through DNA profiling
Which of the following incorrectly describes the advantages of Intellectual Property Rights?
Provides exclusive rights to the creators or inventors in all countries
Encourages individuals to distribute and share information and data instead of keeping it confidential.
Provides legal defense and offers the creators the incentive of their work.
Helps in social and financial development.
Bioequivalence testing is the only clinical trial requirement for Abbreviated New Drug Application (ANDA).
TRUE
FALSE
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?
YES
NO
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.
informed consent
autonomy
clinical trial
protocol
On Clinical trial, which does not correctly describe the phase:
Phase 1 – efficacy with 20-100 participants
Phase 2 – safety and efficacy with 100-300 participants
Phase 3 – safety and efficacy with 1,000-3,00 participants
Phase 4 – FDA review
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.
Precision medicine
Biotechnology
Traditional medicine
Cloud technology
A specific antibiotic which targets ribosomal RNA.
Neomycin
Cefalexin
Tigacycline
Streptomycin
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.
Phase I
Phase II
Phase III
Phase IV
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.
TRUE
FALSE
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. Phase 3
B. Phase 4
C. PMS
B and C
The International Conference on Harmonization (ICH) has the following goals, except:
Make new drugs available with minimum delay
Produce drugs that are affordable
Minimize unnecessary duplicate testing during the research and development
Develop guidance documents that create consistency in the requirements
The trademark protection granted by IP Philippines protects the mark also outside the country.
TRUE
FALSE
The type of animal toxicity testing where its effects are observed for 28 days.
Acute
Sub-acute
Chronic
Sub-chronic
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.
Maximum Tolerated Dose
Highest Dose Tested
Limit Dose
Acute Dose
LD10 means:
the dose that causes 10% effectivity in a population
the dose that causes 10% mortality in a population
median lethal dose
median lethal concentration
The 1st 3D printed drug approved by FDA
Spritam
Zipdose
Aprecia
A type of drug receptor which is targeted structure base:
ligand gated receptor
NZ linked receptor
G protein coupled receptor
intracellular receptor
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.
Trademark
Utility model
Copyright
Industrial design
Afrezza
Inhaled insulin
Insulin patch
Insulin IV
Insulin SQ
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.
Orphan drug act
Hatch-waxman act
Data privacy act
IP code
Last Resort Drug for MRSA
Linezolid
Vancomycin
Corbomycin
Tigecycline
It is a microfluidic chip reproducing the mechanisms of a heart, in order to test medicine quickly and observe the reaction of heart cells.
cardio-on-chip
heart-on-chip
lungs-on-chip
This process delivers information on the effect of a bioactive compound directly on an advanced disease-relevant parameter.
targeting RNA with small molecules
cloud technology
phenotypic screening
3D printing
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.
antibiotics
antifungals
antivirals
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.
Murine local lymph node assay
Guinea pig maximization test
Buehler test
Split adjuvant test
The test animal used for skin sensitization test (Select all that may apply)
Guinea pig
Rabbit
Mice
Rat
Rules and Regulations on the Conduct of Scientific Procedures Using Animals
D.A. A.O. No. 40
D.A. A.O. No. 04
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.
Social value
Autonomy
Informed Consent
Protocols
Taxus brevifolia
Anti-cancer
Anti-viral
Anti-fungal
Anti-bacterial
Multi component analysis of plant extracts can already be performed using the following analytical tools, except:
AAA
NMR
GC
MS
Which is in right order/sequence?
target- lead optimization- lead identification-preformulation
target- lead identification - lead optimization- preformulation
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.
Stability
Thermal effect
Solubility
Common Ion Effect
The degree of crystallinity has a big influence on hardness, density, transparency and diffusion.
True
False
Animal Toxicity Tests duration of study, which is/are incorrect:
(SELECT ALL THAT APPLY)
acute – 14 days
sub-acute – 28 days
chronic – 3 months
sub-chronic – 3 months or more
Gold standard statistical procedure:
RCT
Blinding
Split Person Design
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:
TRADE SECRET
COPYRIGHT
PATENT
TRADEMARK
The office which is responsible for the processing of applications for patent.
IPOPHIL
NATIONAL LIBRARY
SUPREME COURT
PATENT OFFICE
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:
KOREA
JAPAN
US
EUROPE
Advantages of Intellectual Property Rights, except.
provides exclusive rights to creators or inventors
can be enjoyed throughout the authors lifetime
helps in social and financial development
provides incentives of their work
