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[Ther 201] 1st Exam Transes > Principles of Non-Clinical Testing of Drugs and Herbal Products (Nelia P. Cortes-Maramba, MD) > Flashcards

Principles of Non-Clinical Testing of Drugs and Herbal Products (Nelia P. Cortes-Maramba, MD) Flashcards

1
Q

What models are used in pre-clinical studies?

A

Animals

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2
Q

Enumerate the three doctors approved to prescribe drugs

A

Physician
Dentist
Veterinarians

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3
Q

What is the legal concern with testing?

A

There should be good lab practices in doing animal studies.

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4
Q

What are the technical and ethical concerns with testing?

A
  1. Testing should be done for the benefit of humanity
  2. Veterinary drugs are different from human drugs
  3. Additives can kill animals
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5
Q

What is the short title of Republic Act No. 9502?

A

Universally Accessible Cheaper and Quality Medicines Act of 2008

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6
Q

What was added in Republic Act No. 9502?

A

Definition of medicines

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7
Q

What is the definition of drugs and medicine according to Republic Act No. 9502?

A

It is any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in humans or animals.

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8
Q

Why was “Any article other than food intended to affect the structure or any function of the human body or animals” added?

A

Because of the existence of oral and injectable contraceptives

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9
Q

Are devices, components, parts or accessories included in the definition of drugs and medicines?

A

No

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10
Q

What herbal and traditional drugs are classified as drugs and medicines?

A

Those recognised by the Philippine National Drug Formulary

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11
Q

What is FDA Act of 2009 also known as?

A

RA 9711

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12
Q

What did Republic Act 9711 do?

A

It amended certain sections of RA 3720. Specifically, it created the Bureau of Food and Drugs under the Office for Standards and regulation of the Department of Health

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13
Q

What was added to the official definition of drugs in Republic Act 9711?

A

Any documentary supplement to pharmacopoeias were recognised.

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14
Q

What are the four centers under the FDA?

A
  1. Food
  2. Drugs
  3. Cosmetics
  4. Devices
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15
Q

What defined herbal medicine as finished, labeled medicinal products that contain plant materials as active ingredients?

A

Traditional and Alternative Medicine Act Law of 1997

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16
Q

Define: excipients

A

These are pharmacologically inactive substances

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17
Q

T/F: Whenever a synthetic or pure chemical is present as an active ingredient, it is not considered an herbal preparation.

A

True

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18
Q

What is required to apply for FDA registration of an herbal medicine?

A

Certificate of authenticity of the plant specimen by BFAD recognised taxonomist

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19
Q

What do you call the requirement where a description of perception by the senses of the herbal medicine is needed?

A

Organoleptic and macroscopic description

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20
Q

What is the acceptable moisture content for herbal preparations?

A

Not more than 10% (prevents fungal contamination and increases shelf life)

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21
Q

What is the acceptable pH range for herbal preparations?

A

pH should not be less than 3 or greater than 9.

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22
Q

What is the acceptable alcohol content of the herbal preparation?

A

<5% ethyl alcohol and 0% methyl & isopropyl alcohol

Pediatric preparations should have 0% alcohol

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23
Q

Describe the disulfiram reaction

A

Occurs when there is interaction between alcohol and azoles, producing toxic metabolites that cause vomiting and withdrawal

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24
Q

What is the alcohol content of Listerine?

A

18%

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25
Q

What is the acceptable ash content for herbal preparations?

A

Not more than 5%

It should be acid and water insoluble.

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26
Q

What is the acceptable percentage of extractable matter for herbal preparations?

A

Not more than 15 - 21% for water soluble matter and not less than 2% for alcohol soluble matter

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27
Q

What are the acceptable ranges for heavy metal concentrations in herbal preparations?

A

Lead < 10 ppm
Cadmium < 0.3 ppm
Mercury < 0.5 ppm
Arsenic < 5 ppm

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28
Q

What metal causes the development of various types of cancer?

A

Arsenic

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29
Q

What maximum amount of Arsenic does the Philippines want to push for? ASEAN?

A

Philippines - 5 ppm

ASEAN - 10 ppm

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30
Q

What is the acceptable amount of pesticide residue in herbal preparations?

A

0%

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31
Q

What is the acceptable microbial count in herbal preparations?

A

< 10^7 /g

Should be negative for pathogens

32
Q

What is the acceptable amount of aflatoxins in herbal preparations?

A

<20 ppm

It is carcinogenic to the liver.

33
Q

What are the available identification tests for active constituents in plants?

A 
Thin Layer Chromatography (non-volatile)
HPLC
NMR
Mass Spectroscopy
GC
Bioassay (pharmacologic activity)
34
Q

Herbal medicines in China and Japan were found to contain what synthetic substances?

A
  1. Viagra
  2. Corticosteroids
  3. Anabolic steroids
  4. NSAIDs
35
Q

What tests are used to provide evidence of safety?

A
  1. Toxicity Test
  2. Mutagenicity Test (Ames, micronuclear and post-mediate)
  3. Reproductive Test
36
Q

What is the short title for Administrative Order No. 184?

A

Guidelines for the Registration of Traditionally Used Herbal Products

37
Q

What was given emphasis in Administrative Order No. 184?

A

Herbal products should not have any potential for local/systemic toxicity, carcinogenicity and teratogenicity.

38
Q

What is the requirement to be considered a traditionally-used herbal product?

A

Effects must have been documented for at least five decades in medical, historical and ethnological literature

No need for safety and efficacy testing.

39
Q

What is the full title of the ICH Guidelines on Non-Clinical Safety Studies?

A

International Committee on Harmonization Tripartite Guidelines on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals 2013

40
Q

What are the features of a pharmaceutical product?

A
  1. Therapeutic, prophylactic or diagnostic purpose
  2. Modifies physiological functions
  3. Dosage and administration suitable for humans
41
Q

What are the objectives of the ICH guidelines?

A
  1. International standards for non-clinical safety studies
  2. Safe and ethical development and availability of pharmaceuticals
  3. Timely conduct of trials
  4. Reduce unnecessary use of resources
42
Q

How many types of antidotes are there?

43
Q

What is most important when dealing with poisoning?

A

Diagnosis and ABCs of life support

44
Q

What is the treatment for opiate overdose?

A

2 mg of naloxone

45
Q

What are the exceptions to the ICH guidelines?

A

Biotechnology derived products

Pharmaceuticals for life-threatening diseases (i.e. treatment for Ebola virus)

46
Q

What are the goals of non-clinical safety evaluation?

A
  1. Characterization of toxic effects with respect to target organs
  2. Estimation of initial safe starting dose
  3. Identification of parameters for clinical monitoring of adverse effects
47
Q

What animal should be used in modelling vomiting?

48
Q

What animals should not be used in modelling uric acid levels?

A

Dogs (no enzymes for ureases)

49
Q

What do reproduction toxicity studies require?

A

At least one rodent and one non-rodent models

50
Q

T/F: Assessment of photo toxicity, immunotoxicity, juvenile animal toxicity and abuse liability are conducted regularly.

A

False

They are only conducted on a case-to-case basis.

51
Q

When can development of drugs be expedited?

A
  1. Life-threatening or serious diseases without current effective therapy
  2. Innovative therapeutic modalities
  3. Vaccine adjuvants
52
Q

Acute toxicity studies are derived from (1) mammalian species using (2) routes.

A

(1) rodent and non-rodent

(2) oral and parenteral

53
Q

What is the minimum number of days a single dose should be given and observed?

54
Q

How many animals should be used per dose level? How many dose levels should there be?

A

6 (preferably 10) animals

3 - 5 dose levels

55
Q

In human studies, the No Adverse Effect Level is the (1) dose.

56
Q

When log dose interval is used, what is the requirement for synthetic drugs and herbal medicines?

A

0.6 log interval for herbal medicines and 0.1 or 0.01 log dose intervals for synthetic medicines

57
Q

T/F: Lethality should be an intended endpoint in acute toxicity studies.

58
Q

What is the minimum duration of repeated dose toxicity studies in rodents and non-rodents for Phase 1 Human and Phase II Therapeutic Exploratory?

59
Q

Repeated dose toxicity studies should be (1) the duration of proposed human clinical trials.

A

(1) equal to or exceed

60
Q

What is the life span of rats? Mice? Monkey? Orangutan?

A

Rats - 2 years
Mice - 9 - 12 months
Monkey - 6 years
Orangutan - 9 years

61
Q

T/F: Non-rodent and rodent models are used if the drug affects the endocrine system.

62
Q

What is the minimum duration of repeated dose toxicity studies for clinical trials in support of Phase 3?

A

2 week CT - 1 month
1 month CT - 3 months
3 month CT - 6/3 months
>3 month CT - 6 months/chronic

63
Q

What are in vitro tests for the evaluation of mutations and chromosomal damage?

A

Genotoxicity damage (completed prior to Phase III studies)

64
Q

T/F: Cardiogenicity studies may be completed post-approval.

65
Q

Where can male reproductive studies be included?

A

Phase I and II

66
Q

What is the effect of DDT on male reproduction?

A
  1. High oestrogen (feminizing)

2. Low sperm count

67
Q

When is it acceptable to include women of childbearing potential in reproduction studies?

A

Japan - completed female fertility and embryo fetal development
US - pregnancy testing on beta subunit of HCG, birth control use, confirmed menstrual period and informed consent

There should be completed reproductive and genotoxicity studies prior to inclusion of women of child bearing potential not using birth control or whose pregnancy status is unknown.

68
Q

What is the requirement for inclusion of paediatric participants in clinical trials?

A
  1. Need adult human data
  2. Repeated dose toxicity, reproduction toxicity and genotoxicity tests
  3. Juvenile animal studies should be considered.
69
Q

When does a mouse become an adult?

70
Q

When does a rat become an adult?

71
Q

Define: Biotechnology-derived Pharmaceuticals

A

Products derived from characterised cells through a variety of expression systems

72
Q

What are examples of biotechnology-derived pharmaceuticals?

A

Cytokines, plasminogen activators, growth factors, enzymes, hormones, monoclonal antibodies, etc.

73
Q

What are the requirements of the test material?

A

Should be free from impurities and contaminants

74
Q

What is the purpose of a preclinical safety setting?

A

It should define pharmacological and toxicological effects throughout clinical development in compliance with Good Laboratory Practice (GLP).

75
Q

What should be considered in a preclinical safety setting?

A
  1. Selection fo relevant species, age and physiologic state
  2. Manner of delivery-dose, route of administration and treatment regimen
  3. Stability of test material
76
Q

Why are conventional approaches to toxicity testing not necessarily applicable to biopharmaceuticals?

A

Species specific immunogenicity and pleiotropic activity

[Ther 201] 1st Exam Transes (11 decks)

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