[9] Principles in Non-Clinical Testing of Drugs and Herbal Products

Question 1

Only People Who Can Prescribe Medication

Answer 1

Physicians
Dentists
Veterinarians (Cannot prescribe to humans)

Question 2

Can Veterinarians prescribe human drugs for animals?

Answer 2

Yes

Question 3

What can’t you test Gout medication on?

Answer 3

Dogs
Tarsiers

They don’t have the enzymes to produce Urea

Question 4

What Republic Act signed July 23, 2007 clarified the definition of Drugs and Medicine?

Answer 4

RA 9502

Question 5

Definition: Organoleptic

Answer 5

Causes organ movement/action

Question 6

How much alcohol content is allowed for Raw Materials of Herbal Medicines?

How about for pediatric preparations?

Answer 6

Less than 5% Ethyl Alcohol

0%

Question 7

What is the moisture content of products to have at least 2 years shelf life and prevent fungal growth?

Answer 7

=< 10%

Question 8

What are the 5 most common heavy metals?

Answer 8

Cadmium
Arsenic
Lead
Mercury
Chromium

CALM Chrome

Question 9

What is the acceptable amount of Staph or Strep colonies when tested?

Answer 9

0

Question 10

What is more important? Body weight or surface area in terms of drug absorption?

Answer 10

Surface Area

Question 11

Vomiting reflexes are present in what cheap animal to use in studies?

Answer 11

Pigeons

Question 12

How long is an Acute Toxicity Study observation period?

Answer 12

14 Days

Question 13

Is lethality an intended endpoint in studies assessing acute toxicity?

Answer 13

No

Question 14

Define: NOAEL

Answer 14

No Adverse Effect Level

Question 15

Life span of a Rat?

Life span of a Mouse?

Answer 15

2 Years

9-12 Months

Question 16

Genotoxicity Studies should be completed before which Phase of a study?

Answer 16

Phase III

Question 17

How long before a Rat is considered an adult?

What about a Mouse?

Answer 17

Rat: 12 Months

Mouse: 9 Months