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FlashCards for Quizes > DDS QUIZ CHAP 2 AND 3 > Flashcards

DDS QUIZ CHAP 2 AND 3 Flashcards

1
Q

what are Historical Methods of Drug Discovery

A

Natural Resources
Botanic Folklore Remedies
Animal derived

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2
Q

obtained through testing, biological assay, and providing
substances

A

Animal derived

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3
Q

what are examples of animal derived?

A

Hormones
Vaccines

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4
Q

what are the modern advances in sources of new drugs?

A

Genetic Engineering
Human Gene Therapy

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5
Q

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

A

Genetic Engineering

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6
Q

what are the Goal Drug Overview marami yun

A
  • 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
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7
Q

What are Methods of Drug Discovery?

A

Screening
Molecular modification

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8
Q

testing a large number of compounds for biologic activity + bioassay

A

screening

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9
Q

altering known compounds to improve drug-like
properties

A

molecular modification

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10
Q

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

A

Mechanism-based drug design

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11
Q

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

A

Lead Compound

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12
Q

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

A

Lead Compound

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13
Q

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

A

Prodrugs

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14
Q

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

A

Prodrugs

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15
Q

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

A

Prodrugs

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16
Q

Prodrugs may be designed preferentially for?

A

Solubility
Absorption
Biostability
Prolonged release

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17
Q

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

A

Biologic Characterization

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18
Q

Various scientists collaborate in studies involving?

A
  • Pharmacology
  • Drug metabolism
  • Toxicity
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19
Q

Studies drugs, their properties, actions, and uses

A

Pharmacology

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20
Q

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

A

Pharmacology

21
Q

What are the subfields of Pharmacology?

A

Pharmacodynamics (drug effects and mechanisms)

  • Pharmacokinetics (absorption, distribution, metabolism and excretion)
  • Clinical pharmacology (effects in humans)
22
Q

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.

A

Drug Metabolism

23
Q

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

A

Drug Metabolism

24
Q

What are the 2 animal species commonly used in biologic characterization

A
  • Rodents
  • Dogs
25
Q

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

A

Toxicology

26
Q

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

A

Toxicology

27
Q

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
A

Toxicology

28
Q

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

A

Carcinogenicity Studies

29
Q
  • Reproduction Studies
    Included in these studies are:
  • Fertility and mating behavior
  • Early embryonic, prenatal and postnatal development
  • Multigenerational effects
  • Teratology
A

Toxicology

30
Q
  • Genotoxicity or Mutagenicity Studies
  • Determines whether the test compound can affect gene mutation or cause
    chromosome or DNA damage
A

Toxicology

31
Q

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

A

Partition Coefficient

32
Q

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

A

Dissolution Rate

33
Q

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

A

Physical form

34
Q

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

A

Stability

35
Q

what are drug stability testing in various environments

A

Humidity

Light

Air

36
Q

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

A

Investigational New Drug Application

37
Q

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

A

Investigational New Drug Application

38
Q

What phase are the safety and tolerability endpoint?

A

Phase 1 Clinical Trials

39
Q

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

A

Phase 1 Clinical Trials

40
Q

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?

A

Phase 2 Clinical Trials

41
Q

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

A

Phase 2 Clinical Trials

42
Q

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?

A

Phase 2 clinical trials

43
Q

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

A

Phase 2 Clinical Trials

44
Q

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

A

Phase 3 Clinical Trials

45
Q

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?

A

Phase 3 Clinical Trials

46
Q

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?

A

Phase 3 Clinical Trials

47
Q

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

A

Phase 3 Clinical Trials

48
Q

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?

A

post clinical trial

49
Q

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?

A

Post clinical trial

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