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MEDICINAL ORGANIC CHEMISTRY > DDD > Flashcards

DDD Flashcards

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1
Q

First drug created containing an active ingredient with established efficacy, safety, & quality and received approval for use

A

Innovator Drug

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2
Q

First retroviral inhibitor approved for the tx of AIDS

A

Zidovudine (Azidothymidine - AZT)

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3
Q

On average, drug discovery and development could take about ____ years.

A

12

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4
Q

The identification of a single marketed drug has a success rate of ____.

A

< 0.001%

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5
Q

DRUG DISCOVERY

The choice of disease and identification of biological target

Identify the step in drug discovery.

A

(1)
Target Discovery

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6
Q

DRUG DISCOVERY

Expected molecular target (gene, protein, nucleic acid of a small molecule) is certified

Identify the step in drug discovery.

A

(2)
Target Validation

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7
Q

DRUG DISCOVERY

Structurally related compounds with identified desired biologically activity are identified (HIT and LEAD) through biological screening of large numbers of compounds

Identify the step in drug discovery.

A

(3)
Lead Discovery

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8
Q

DRUG DISCOVERY

Lead compounds are modified and studied to identify potential candidate for drug development

Identify the step in drug discovery.

A

(4)
Lead Optimization

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9
Q

DRUG DISCOVERY

Maintain favorable properties and enhance deficiency on structure

Identify the step in drug discovery.

A

(4)
Lead Optimization

Goals

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10
Q

DRUG DISCOVERY

Early stages of pharmacological studies are helpful to characterize the MOA of the compound

Identify the step in drug discovery.

A

(5)
Product Characterization

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11
Q

DRUG DISCOVERY

A stage of drug development during which the physicochemical properties of APIS are characterized to produce a bioavailable, stable, and optimal dosage form for a specific administration route

Identify the step in drug discovery.

A

(6)
Pharmaceutical Formulation/ Formulational Development

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12
Q

DRUG DISCOVERY

Data mining using bioinformatics

Identify the step in drug discovery.

A

(1)
Target Discovery

Approaches

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13
Q

DRUG DISCOVERY

Genetic association

Identify the step in drug discovery.

A

(1)
Target Discovery

Approaches

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14
Q

DRUG DISCOVERY

Expression profile

Identify the step in drug discovery.

A

(1)
Target Discovery

Approaches

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15
Q

DRUG DISCOVERY

Pathway and phenotypic analysis

Identify the step in drug discovery.

A

(1)
Target Discovery

Approaches

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16
Q

DRUG DISCOVERY

Functional screening

Identify the step in drug discovery.

A

(1)
Target Discovery

Approaches

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17
Q

DRUG DISCOVERY

SAR of the analogs

Identify the step in drug discovery.

A

(2)
Target Validation

Strategies

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18
Q

DRUG DISCOVERY

Generation of drug-resistant mutant

Identify the step in drug discovery.

A

(2)
Target Validation

Strategies

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19
Q

DRUG DISCOVERY

Knockdown/over expression of target

Identify the step in drug discovery.

A

(2)
Target Validation

Strategies

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20
Q

DRUG DISCOVERY

Monitoring the known signaling systems downstream of the presumed target

Identify the step in drug discovery.

A

(2)
Target Validation

Strategies

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21
Q

DRUG DISCOVERY

Reproducibility

Identify the step in drug discovery.

A

(2)
Target Validation

Key Steps

22
Q

DRUG DISCOVERY

Introduce variation to drug-target environment

Identify the step in drug discovery.

A

(2)
Target Validation

Key Steps

23
Q

DRUG DISCOVERY

SAR identified

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

24
Q

DRUG DISCOVERY

Drug ability (preliminary toxicity)

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

25
Q

DRUG DISCOVERY

Synthetic feasibility

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

26
Q

DRUG DISCOVERY

Select mechanistic assays

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

27
Q

DRUG DISCOVERY

In vitro assessment of drug resistance and efflux potential

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

28
Q

DRUG DISCOVERY

PK/Toxicity of chemical class known based on preliminary toxicity or in silico studies

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

29
Q

DRUG DISCOVERY

Evidence of in vivo efficacy of chemical class

Identify the step in drug discovery.

A

(3)
Lead Discovery

Characteristics

30
Q

DRUG DISCOVERY

Selectivity and binding mechanism as the final step in early-stage of drug discovery

Identify the step in drug discovery.

A

(4)
Lead Optimization

31
Q

DRUG DISCOVERY

The final step in early-stage of drug discovery

A

Selectivity and binding mechanism during lead optimization

32
Q

DRUG DEVELOPMENT

Decides whether a drug is ready for clinical trials and
involves extensive studies (animal models) that yield
preliminary information on efficacy, toxicity, pharmacokinetic, and safety

Identify the step in drug development.

A

(0)
Pre-Clinical Studies

33
Q

DRUG DEVELOPMENT

General pharmacology

Identify the step in drug development.

A

(0)
Pre-Clinical Studies

Approaches

34
Q

DRUG DEVELOPMENT

Toxicology

Identify the step in drug development.

A

(0)
Pre-Clinical Studies

Approaches

35
Q

DRUG DEVELOPMENT

Requests permission to move a clinical candidate to human study

Identify the step in drug development.

A

(1)
INDA

Submission of an Investigational New Drug Application

36
Q

DRUG DEVELOPMENT

Provides regulatory agencies with detailed preclinical data and detailed clinical protocols that describe how the compounds will be studies in human populations.

Identify the step in drug development.

A

(1)
INDA

Submission of an Investigational New Drug Application

37
Q

DRUG DEVELOPMENT

Data collection and analysis

Identify the step in drug development.

A

(2)
Clinical Research
(Clinical Trials)

Purpose

38
Q

DRUG DEVELOPMENT

Investigative FIH trials that follows USFDA guidelines

Identify the phase of clinical trial.

A

Phase 0

(2) Clinical Research (Clinical Trials)

39
Q

DRUG DEVELOPMENT

Human micro dose studies with 10 to 15 healthy volunteers

Identify the phase of clinical trial.

A

Phase 0

(2) Clinical Research (Clinical Trials)

40
Q

DRUG DEVELOPMENT

Safety and tolerability

Identify the phase of clinical trial.

A

Phase 1

(2) Clinical Research (Clinical Trials)

41
Q

DRUG DEVELOPMENT

20-100 healthy individuals

Identify the phase of clinical trial.

A

Phase 1

(2) Clinical Research (Clinical Trials)

42
Q

DRUG DEVELOPMENT

Safety and efficacy

Identify the phase of clinical trial.

A

Phase 2

(2) Clinical Research (Clinical Trials)

43
Q

DRUG DEVELOPMENT

100-300 patients

Identify the phase of clinical trial.

A

Phase 2

(2) Clinical Research (Clinical Trials)

44
Q

DRUG DEVELOPMENT

Efficacy of IND in larger population including comparison with standard therapies

Identify the phase of clinical trial.

A

Phase 3

(2) Clinical Research (Clinical Trials)

45
Q

DRUG DEVELOPMENT

Comprehensive details of both animals and human studies including safety findings, manufacturing procedures, dosing methods, and storage conditions

Identify the step in drug development.

A

(3)
NDA submission to regulatory body

New Drug Application

46
Q

DRUG DEVELOPMENT

FDA Review

Identify the step in drug development.

A

(3)
NDA submission to regulatory body

New Drug Application

47
Q

DRUG DEVELOPMENT

Alterations to labeling based on safety results

Identify the step in drug development.

A

(4)
Phase 4 Clinical Trial
(Post-Marketing Surveillance)

Impacts

48
Q

DRUG DEVELOPMENT

Detects rare and long term adverse effects across a much larger population of patients than could be supported in Phase III

Identify the step in drug development.

A

(4)
Phase 4 Clinical Trial
(Post-Marketing Surveillance)

49
Q

DRUG DEVELOPMENT

Contraindication for use of the new drug in combination with other medications

Identify the step in drug development.

A

(4)
Phase 4 Clinical Trial
(Post-Marketing Surveillance)

50
Q

DRUG DEVELOPMENT

Withdrawal of marketing approval if the findings are severe enough

Identify the step in drug development.

A

(4)
Phase 4 Clinical Trial
(Post-Marketing Surveillance)

51
Q

DRUG DEVELOPMENT

Identify competitive advantages, new markets, and new indications for the products

Identify the step in drug development.

A

(4)
Phase 4 Clinical Trial
(Post-Marketing Surveillance)

MEDICINAL ORGANIC CHEMISTRY (17 decks)

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