DDS QUIZ CHAP 2 AND 3

Question 1

what are Historical Methods of Drug Discovery

Answer 1

Natural Resources
Botanic Folklore Remedies
Animal derived

Question 2

obtained through testing, biological assay, and providing
substances

Answer 2

Animal derived

Question 3

what are examples of animal derived?

Answer 3

Hormones
Vaccines

Question 4

what are the modern advances in sources of new drugs?

Answer 4

Genetic Engineering
Human Gene Therapy

Question 5

modifying genetic material in cells to correct
malfunctioning genes (altering gene expression or sequence)

Answer 5

Genetic Engineering

Question 6

what are the Goal Drug Overview marami yun

Answer 6

• Specified desired effect
• Optimal administration route
• Minimal dosage and frequency
• Onset and duration
• Minimal side effects
• Efficient elimination
• Production ease and low cost
• Pharmaceutical elegance
• Stability in various conditions
• These qualities are sought out in drug
  and dosage form design although not
  completely attainable

Question 7

What are Methods of Drug Discovery?

Answer 7

Screening
Molecular modification

Question 8

testing a large number of compounds for biologic activity + bioassay

Answer 8

screening

Question 9

altering known compounds to improve drug-like
properties

Answer 9

molecular modification

Question 10

aims to create drugs that create/interfere target
specific biochemical pathways or mechanisms of disease;

Answer 10

Mechanism-based drug design

Question 11

Is a prototype chemical compound that has a fundamental desired biologic or
pharmacologic activity.

Answer 11

Lead Compound

Question 12

it may not possess all of the features desired, such as potency,
absorbability, solubility, low toxicity and so forth.

Answer 12

Lead Compound

Question 13

Is an inactive compound that needs metabolic transformation within the body to
become an active, pharmacologically effective substance.

Answer 13

Prodrugs

Question 14

can be strategically designed for improved properties such as
solubility, absorption, stability and prolonged release.

Answer 14

Prodrugs

Question 15

This transformation/conversion is carried out by enzymes, involving biochemical
cleavage

Answer 15

Prodrugs

Question 16

Prodrugs may be designed preferentially for?

Answer 16

Solubility
Absorption
Biostability
Prolonged release

Question 17

Prospective drug substances must undergo preclinical testing for biologic activity to
assess their potential as useful therapeutic agents.

Answer 17

Biologic Characterization

Question 18

Various scientists collaborate in studies involving?

Answer 18

• Pharmacology
• Drug metabolism
• Toxicity

Question 19

Studies drugs, their properties, actions, and uses

Answer 19

Pharmacology

Question 20

It covers aspects like how drug interacts with the body, their effects , and how the
body processes them.

Answer 20

Pharmacology

Question 21

What are the subfields of Pharmacology?

Answer 21

Pharmacodynamics (drug effects and mechanisms)

• Pharmacokinetics (absorption, distribution, metabolism and excretion)
• Clinical pharmacology (effects in humans)

Question 22

In simple terms: it is the process by which our bodies break down and change
drugs into different forms so that they can easily be eliminated from our bodies.

Answer 22

Drug Metabolism

Question 23

The rate, primary and secondary sites, the mechanism of the drug’s metabolism
in the body, and the chemistry and pharmacology of any metabolites

Answer 23

Drug Metabolism

Question 24

What are the 2 animal species commonly used in biologic characterization

Answer 24

• Rodents
• Dogs

Question 25

Focuses on studying the negative/adverse effects of drugs. Although the ability to predict the safe use of a new drug in humans based on preclinical animal studies is desirable, it is not entirely achievable

Answer 25

Toxicology

Question 26

Acute or Short Term Toxicity Studies - these studies are designed to determine the toxic effects of a test compound when administered in a single dose and/or in multiple doses over a short period, usually a single day

Answer 26

Toxicology

Question 27

Subacute or Subchronic studies * Animal toxicity studies of a minimum of 2 weeks of daily drug administration at three or more dosage levels to two animal species are required

Answer 27

Toxicology

Question 28

Is usually a component of chronic testing and is undertaken when the compound has shown sufficient promise as a drug to enter human clinical trials

Answer 28

Carcinogenicity Studies

Question 29

* Reproduction Studies Included in these studies are: * Fertility and mating behavior * Early embryonic, prenatal and postnatal development * Multigenerational effects * Teratology

Answer 29

Toxicology

Question 30

* Genotoxicity or Mutagenicity Studies * Determines whether the test compound can affect gene mutation or cause chromosome or DNA damage

Answer 30

Toxicology

Question 31

Is a term used to describe how a substance distributes itself between two different phases

Answer 31

Partition Coefficient

Question 32

The speed at which a drug substance dissolved in a medium/solvent (e.g water, bodily fluids)

Answer 32

Dissolution Rate

Question 33

The crystal or amorphous forms and/or the particle size of a powdered drug can affect the dissolution rate, and thus the rate and extent of absorption, for a number of drugs

Answer 33

Physical form

Question 34

Example: for drugs susceptible to oxidation = antioxidant stabilizing agents Example: for drugs susceptible to hydrolysis = protection against moisture, processing, and packaging may be required to prevent decomposition

Answer 34

Stability

Question 35

what are drug stability testing in various environments

Answer 35

Humidity Light Air

Question 36

Sponsor of a new drug is required to file with the FDA an IND before the drug may be given to human subjects

Answer 36

Investigational New Drug Application

Question 37

A clinical protocol must be submitted to ensure appropriate design and conduct of the investigation.

Answer 37

Investigational New Drug Application

Question 38

What phase are the safety and tolerability endpoint?

Answer 38

Phase 1 Clinical Trials

Question 39

Sample size: Small, usually consisting of tens to hundreds of participants, what phase is this?

Answer 39

Phase 1 Clinical Trials

Question 40

is to evaluate the drugs’ effectiveness and further assess its safety in a larger sample of participants. It aims to gather initial evidence of the drug’s efficacy in treating the target disease or condition. What Phase is this?

Answer 40

Phase 2 Clinical Trials

Question 41

refine the dosage range determined in phase I and further investigate the drug’s effectiveness at specific doses. what phase is this?

Answer 41

Phase 2 Clinical Trials

Question 42

the primary point of this phase are trials include efficacy measures relevant to the target or condition. These endpoints may include disease response rates, improvement in symptoms or biomarker changes. What endpoint is this?

Answer 42

Phase 2 clinical trials

Question 43

trials involve moderate sample size, typically in the range of hundreds of participants. What phase is this?

Answer 43

Phase 2 Clinical Trials

Question 44

Gather substantial evidence regarding the safety and efficacy of the investigational drug in a larger and more diverse population. What phase is this?

Answer 44

Phase 3 Clinical Trials

Question 45

These trials aim to confirm and extend the findings from earlier phases and provide a more robust assessment of the drug’s benefits and risk. What phase is this?

Answer 45

Phase 3 Clinical Trials

Question 46

employ a randomized and controlled design to determine the efficacy and safety of the investigational drug compared to standard treatments or placebo. What phase is this?

Answer 46

Phase 3 Clinical Trials

Question 47

determines disease progression, overall survival, quality of life or reduction in specific symptoms, additional measures of efficacy and safety. what phase is this?

Answer 47

Phase 3 Clinical Trials

Question 48

Regulatory Submission: Upon completion of Phase III trials, the drug developer/ sponsor analyzes the trial data and prepares a comprehensive New Drug Application (NDA) or Marketing Authorization Application (MAA) for submission to regulatory agencies. what phase is this?

Answer 48

post clinical trial

Question 49

Post-Marketing Surveillance: if the drug received regulatory approval based on the Phase III trial results. It can be marketed and made available to the public. what phase is this?

Answer 49

Post clinical trial