Eval of Drugs

Question 1

steps in drug development

Answer 1

1. Drug Discovery and Design
2. Pre-Clinical Studies
3. INDA
4. Clinical Trials
5. NDA
6. Post-Marketing Surveillance

Question 2

prototype moiety with desired pharmacologic activity

Answer 2

Lead Compound

Question 3

where preformulation, drug characterization and formulation happens

Answer 3

Pre-clinical

Question 4

most critical and demanding stage

Answer 4

Clinical trials

Question 5

Phase of Clinical Trial in which relationship of mechanism of action and treatment of disease is known

Answer 5

Phase 0

Question 6

for orphan drugs (used to treat rare diseases)

Answer 6

Accelerated programs for drug approval

Question 7

to determine if the drug is sufficiently safe for clinical trials

Answer 7

INDA

Question 8

provides the framework for the drug’s combination with excipients in the fabrication of the final dosage form

Answer 8

Preformulation

Question 9

pilot production/initial dosage form for clinical trials

Answer 9

Formulation

Question 10

meaning of INDA

Answer 10

Investigational New Drug Application

Question 11

requirements for INDA

Answer 11

• drug source and composition
• manufacturing process
• results from animal
studies
• clinicaltrialprotocols
• profiles of physicians who will conduct the clinical trials

Question 12

Clinical Trials are evaluated by what

Answer 12

IRB (Institutional Review Boards)

Question 13

Clinical Trials are monitored by

Answer 13

CRA (Clinical Research Associates)

Question 14

Phase of clinical trial in which it is conducted in settings similar to those anticipated for the ultimate use of the drug

Answer 14

Phase 3

Question 15

full reports of all pre-clinical and clinical data; to gain permission to market the new drug

Answer 15

NDA

Question 16

longest phase of clinical trial

Answer 16

Phase 3 (2-3 years)

Question 17

investigates safety, pharmacokinetics, ideal dosage range of drugs

Answer 17

phase 1

Question 18

T/F Phase 1 is a single-blind design, with placebo and established active drug in addition to the investigational agent

Answer 18

F. Phase 2 yan. Phase 1 ay non-blind or open studies

Question 19

T/F Phase 2 has broader range of toxicities

Answer 19

T

Question 20

What property is phase 2 focused on

Answer 20

Efficacy

Question 21

Phase in which certain toxic effects may first become apparent

Answer 21

Phase 3

Question 22

phase in which it is conducted in research centers

Answer 22

Phase 1

Question 23

where is phase 2 conducted

Answer 23

special clinical centers or university hospitals

Question 24

1/100th of the dose calculated to yield a pharmacological effect

Answer 24

microdoses

Question 25

includes additional pharmacological & toxicological data; adverse drug reaction reporting and product defect reporting

Answer 25

Phase 4/Post-marketing