DDD

Question 1

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

Answer 1

Innovator Drug

Question 2

First retroviral inhibitor approved for the tx of AIDS

Answer 2

Zidovudine (Azidothymidine - AZT)

Question 3

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

Answer 3

12

Question 4

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

Answer 4

< 0.001%

Question 5

DRUG DISCOVERY

The choice of disease and identification of biological target

Identify the step in drug discovery.

Answer 5

(1)
Target Discovery

Question 6

DRUG DISCOVERY

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

Identify the step in drug discovery.

Answer 6

(2)
Target Validation

Question 7

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.

Answer 7

(3)
Lead Discovery

Question 8

DRUG DISCOVERY

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

Identify the step in drug discovery.

Answer 8

(4)
Lead Optimization

Question 9

DRUG DISCOVERY

Maintain favorable properties and enhance deficiency on structure

Identify the step in drug discovery.

Answer 9

(4)
Lead Optimization

Goals

Question 10

DRUG DISCOVERY

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

Identify the step in drug discovery.

Answer 10

(5)
Product Characterization

Question 11

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.

Answer 11

(6)
Pharmaceutical Formulation/ Formulational Development

Question 12

DRUG DISCOVERY

Data mining using bioinformatics

Identify the step in drug discovery.

Answer 12

(1)
Target Discovery

Approaches

Question 13

DRUG DISCOVERY

Genetic association

Identify the step in drug discovery.

Answer 13

(1)
Target Discovery

Approaches

Question 14

DRUG DISCOVERY

Expression profile

Identify the step in drug discovery.

Answer 14

(1)
Target Discovery

Approaches

Question 15

DRUG DISCOVERY

Pathway and phenotypic analysis

Identify the step in drug discovery.

Answer 15

(1)
Target Discovery

Approaches

Question 16

DRUG DISCOVERY

Functional screening

Identify the step in drug discovery.

Answer 16

(1)
Target Discovery

Approaches

Question 17

DRUG DISCOVERY

SAR of the analogs

Identify the step in drug discovery.

Answer 17

(2)
Target Validation

Strategies

Question 18

DRUG DISCOVERY

Generation of drug-resistant mutant

Identify the step in drug discovery.

Answer 18

(2)
Target Validation

Strategies

Question 19

DRUG DISCOVERY

Knockdown/over expression of target

Identify the step in drug discovery.

Answer 19

(2)
Target Validation

Strategies

Question 20

DRUG DISCOVERY

Monitoring the known signaling systems downstream of the presumed target

Identify the step in drug discovery.

Answer 20

(2)
Target Validation

Strategies

Question 21

DRUG DISCOVERY

Reproducibility

Identify the step in drug discovery.

Answer 21

(2)
Target Validation

Key Steps

Question 22

DRUG DISCOVERY

Introduce variation to drug-target environment

Identify the step in drug discovery.

Answer 22

(2)
Target Validation

Key Steps

Question 23

DRUG DISCOVERY

SAR identified

Identify the step in drug discovery.

Answer 23

(3)
Lead Discovery

Characteristics

Question 24

DRUG DISCOVERY

Drug ability (preliminary toxicity)

Identify the step in drug discovery.

Answer 24

(3)
Lead Discovery

Characteristics

Question 25

# DRUG DISCOVERY Synthetic feasibility | Identify the step in drug discovery.

Answer 25

(3) Lead Discovery | Characteristics

Question 26

# DRUG DISCOVERY Select mechanistic assays | Identify the step in drug discovery.

Answer 26

(3) Lead Discovery | Characteristics

Question 27

# DRUG DISCOVERY In vitro assessment of drug resistance and efflux potential | Identify the step in drug discovery.

Answer 27

(3) Lead Discovery | Characteristics

Question 28

# DRUG DISCOVERY PK/Toxicity of chemical class known based on preliminary toxicity or in silico studies | Identify the step in drug discovery.

Answer 28

(3) Lead Discovery | Characteristics

Question 29

# DRUG DISCOVERY Evidence of in vivo efficacy of chemical class | Identify the step in drug discovery.

Answer 29

(3) Lead Discovery | Characteristics

Question 30

# DRUG DISCOVERY Selectivity and binding mechanism as the final step in early-stage of drug discovery | Identify the step in drug discovery.

Answer 30

(4) Lead Optimization

Question 31

# DRUG DISCOVERY The final step in early-stage of drug discovery

Answer 31

Selectivity and binding mechanism during lead optimization

Question 32

# 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.

Answer 32

(0) Pre-Clinical Studies

Question 33

# DRUG DEVELOPMENT General pharmacology | Identify the step in drug development.

Answer 33

(0) Pre-Clinical Studies | Approaches

Question 34

# DRUG DEVELOPMENT Toxicology | Identify the step in drug development.

Answer 34

(0) Pre-Clinical Studies | Approaches

Question 35

# DRUG DEVELOPMENT Requests permission to move a clinical candidate to human study | Identify the step in drug development.

Answer 35

(1) INDA | Submission of an Investigational New Drug Application

Question 36

# 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.

Answer 36

(1) INDA | Submission of an Investigational New Drug Application

Question 37

# DRUG DEVELOPMENT Data collection and analysis | Identify the step in drug development.

Answer 37

(2) Clinical Research (Clinical Trials) | Purpose

Question 38

# DRUG DEVELOPMENT Investigative FIH trials that follows USFDA guidelines | Identify the phase of clinical trial.

Answer 38

Phase 0 | (2) Clinical Research (Clinical Trials)

Question 39

# DRUG DEVELOPMENT Human micro dose studies with 10 to 15 healthy volunteers | Identify the phase of clinical trial.

Answer 39

Phase 0 | (2) Clinical Research (Clinical Trials)

Question 40

# DRUG DEVELOPMENT Safety and tolerability | Identify the phase of clinical trial.

Answer 40

Phase 1 | (2) Clinical Research (Clinical Trials)

Question 41

# DRUG DEVELOPMENT 20-100 healthy individuals | Identify the phase of clinical trial.

Answer 41

Phase 1 | (2) Clinical Research (Clinical Trials)

Question 42

# DRUG DEVELOPMENT Safety and efficacy | Identify the phase of clinical trial.

Answer 42

Phase 2 | (2) Clinical Research (Clinical Trials)

Question 43

# DRUG DEVELOPMENT 100-300 patients | Identify the phase of clinical trial.

Answer 43

Phase 2 | (2) Clinical Research (Clinical Trials)

Question 44

# DRUG DEVELOPMENT Efficacy of IND in larger population including comparison with standard therapies | Identify the phase of clinical trial.

Answer 44

Phase 3 | (2) Clinical Research (Clinical Trials)

Question 45

# 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.

Answer 45

(3) NDA submission to regulatory body | New Drug Application

Question 46

# DRUG DEVELOPMENT FDA Review | Identify the step in drug development.

Answer 46

(3) NDA submission to regulatory body | New Drug Application

Question 47

# DRUG DEVELOPMENT Alterations to labeling based on safety results | Identify the step in drug development.

Answer 47

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

Question 48

# 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.

Answer 48

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

Question 49

# DRUG DEVELOPMENT Contraindication for use of the new drug in combination with other medications | Identify the step in drug development.

Answer 49

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

Question 50

# DRUG DEVELOPMENT Withdrawal of marketing approval if the findings are severe enough | Identify the step in drug development.

Answer 50

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

Question 51

# DRUG DEVELOPMENT Identify competitive advantages, new markets, and new indications for the products | Identify the step in drug development.

Answer 51

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