Drug Development

Question 1

An agent used in the diagnosis, mitigation,
treatment, cure, or prevention of diseases in
humans and animals.

Answer 1

Drug

Question 2

Greek physician who is
credited with the
introduction of scientific
pharmacy and medicine.

Answer 2

Hippocrates

Question 3

Hippocrates is known as the ______

Answer 3

Father of Medicine

Question 4

Established the Theory of Humoral Pathology

Answer 4

Hippocrates

Question 5

Greek physician, botanist, and Pharmacologist who dealt with botany as an applied science of Pharmacy

Answer 5

Pedanius Dioscorides

Question 6

Work of Pedanius Dioscorides which served as a milestone in the development of pharmaceutical botany and pharmacognosy.

Answer 6

De Materia Medica

Question 7

Swiss physician and chemist who
introduced chemical science from the
traditional botanical science.

Answer 7

Aureolus Philipus Theophrastus Bombastus von Hohenheim (Paracelsus)

Question 8

A Swedish Pharmacist who discovered Oxygen a year before

Priestley.

Answer 8

Karl Wilhelm Scheele

Question 9

German pharmacist who isolated morphine

from opium.

Answer 9

Friedrich Serturner

Question 10

He independently isolated codeine from opium

Answer 10

Pierre Robiquet

Question 11

They isolated quinine and cinchonine from

cinchona.

Answer 11

Joseph Caventou and Joseph Pelletier

Question 12

Discovered strychnine and

brucine from Nux vomica.

Answer 12

Joseph Caventou and Joseph Pelletier

Question 13

Isolated caffeine

Answer 13

Pierre Robiquet and Joseph Pelletier

Question 14

The scientific basis for drug products
to ensure uniformity and quality
leading to the development and
publication of monographs.

Answer 14

Drug Standards

Question 15

The term pharmacopoeia comes from the
Greek word “_______” (drug) and
“_______” (to make).

Answer 15

Pharmakon

Poiein

Question 16

Present official standard of Purity, Strength,

Quality, and Analysis of drugs

Answer 16

Pharmacopeia

Question 17

Contains drug
monographs which assured availability
of quality drugs and pharmaceutical
products.

Answer 17

Official Compendia

Question 18

The first American pharmacopeia published

in 1778 at Lititz, Pennsylvania.

Answer 18

Lititz Pharmacopeia

Question 19

Lititz Pharmacopeia was a 32-page booklet consisting of __
internal and __ external drugs and
preparations.

Answer 19

84 internal and 16 external drugs

Question 20

The Father of USP

Answer 20

Dr. Lyman Spalding

Question 21

When was the first USP published in English and Latin

Answer 21

December 15, 1820

Question 22

The first USP was a 272-

page and ___ drugs were listed in it.

Answer 22

217 drugs

Question 23

T/F : At first, the revision of USP was every 10
years but was decided to revise it every 5
years (1940).

Answer 23

True

Question 24

In 1888, the first National Formulary was

published under the title ____________

Answer 24

“National

Formulary of Unofficial Drugs”.

Question 25

T/F: In 1975, US pharmacopoeial convention purchased NF.

Answer 25

True

Question 26

T/F: In 1980, the first combined compendium | (USP-NF) was published.

Answer 26

True

Question 27

T/F: In 1864, the first English | Pharmacopoeia was published

Answer 27

False. In 1864, the first British Pharmacopoeia was published.

Question 28

Contents of the Monograph

Answer 28

1. Official Title (Generic Name) 2. Graphic or Structural Formula 3. Empirical Formula 4. Molecular Weight 5. Established Chemical Names 6. Chemical Abstracts Service (CAS) Registry Number 7. Chemical Purity- In terms of percentage 8. Cautionary Statement 9. Packaging 10. Storage 11. Chemical and Physical Tests 12. Method of Assay

Question 29

Other References to Drug Standards:

Answer 29

• Homeopathic Pharmacopoeia of the United States (HPUS) • International Pharmacopoeia/ Pharmacopeia Internationalis (Published by WHO) • BP • EP

Question 30

Sources of New Drugs

Answer 30

* Plant Kingdom * Animal sources * Microbiological world * Biological Source

Question 31

An animal source developed from vampire bat saliva to treat heart attacks and strokes in humans

Answer 31

Draculin

Question 32

For thyroid extract, insulin and pituitary hormone (Replacement Therapy).

Answer 32

Endocrine glands of cattle, sheep, and swine

Question 33

Source of Estrogen

Answer 33

Urine of pregnant mares

Question 34

Serums, Anti-toxins, and Vaccines

Answer 34

Biological Sources

Question 35

Who discovered the smallpox vaccine in England in 1976?

Answer 35

Edward Jenner

Question 36

Characteristics of Goal Drug

Answer 36

• Produces the specifically the desired effect • Administered by the most desired route(Generally orally) • Minimal dosage and dosage frequency • Has optimal onset and duration of activity • Easily produced at low cost • Pharmaceutically elegant • Physically and chemically stable in various conditions of use and storage • Exhibit no side effect • Would be eliminated completely and without residual effect

Question 37

Drug Discovery

Answer 37

``` • Choosing a Disease – Focus is on the financial return • Choosing a drug Target – Receptor, enzymes, and metabolic processes. • Medical Folklore • Existing Drugs • Combinatorial Synthesis • Molecular Modification • Mechanism-based Design • Computer-aided Design • Serendipity and Prepared Mind • Use of NMR ```

Question 38

Initial bioassay that takes place outside the organism, in an artificial environment such as a laboratory where drug activity is tested on isolated tissues, cells, or enzymes.

Answer 38

In Vitro Test

Question 39

Subsequent bioassay by biological experiment or technique carried out within a living organism

Answer 39

In Vivo Test

Question 40

20 to 80 healthy volunteers

Answer 40

Phase 1

Question 41

100 to 300 patient volunteers

Answer 41

Phase 2

Question 42

1000 to 3000 patient volunteers

Answer 42

Phase 3

Question 43

Laboratory and animal studies

Answer 43

Pre-clinical testing

Question 44

The phase which determines safety and | dosage, and Bioavailability of the drug

Answer 44

Phase 1

Question 45

Evaluate effectiveness, look for side effects

Answer 45

Phase 2

Question 46

Verify effectiveness, monitor adverse reactions from longterm use

Answer 46

Phase 3

Question 47

Assess safety and biological activity

Answer 47

Pre-clinical testing

Question 48

Pre-clinical studies

Answer 48

* Chemical and Physical Characterization * Pharmacology * Pharmacokinetics * Pharmacodynamics * Pharmaceutics * Analytical studies * Toxicology

Question 49

T/F: In Double Blind Studies, the patient does not know or unaware of the agent administered while in Single Blind Studies, neither the patient nor the clinician is aware of the agent administered.

Answer 49

False. • Single Blind Studies - The patient does not know or unaware of the agent administered. • Double Blind Studies - Neither the patient nor the clinician is aware of the agent administered.

Question 50

Parties are aware of the agents’ identities that will be administered to them.

Answer 50

Open Label Studies

Question 51

T/F: NDA is submitted to the FDA for review and approval after the completion of the clinical trials and requirements have been met.

Answer 51

True

Question 52

The Post Marketing Studies and manufacturing scale-up | activities take place.

Answer 52

Phase IV

Question 53

Increase in the batch size from the clinical batch, submission batch, or to the full-scale production batch size, using the finished, marketed product.

Answer 53

Scale Up

Question 54

T/F: In Phase 4, product development can not be continued.

Answer 54

False. Product development may continue.

Question 55

Filed for generic copies by competing companies following expiration of patent term protection.

Answer 55

ANDA or Abbreviated New Drug Application

Question 56

There are changes in synthesis, formulation, analytical standards, containers, and labeling of drug products.

Answer 56

SNDA or Supplemental New Drug Application

Question 57

A prototype chemical compound that has a | fundamental desired biologic or pharmacologic activity.

Answer 57

Lead Compound

Question 58

T/F: Since most drugs have primary and secondary effects, taking advantage of secondary effects leads to a drugs secondary indication.

Answer 58

True

Question 59

A compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound.

Answer 59

Prodrugs

Question 60

A combination of two or more old drugs or change in usual proportions of drugs in an established combination product is considered new if the change alter safety and efficacy.

Answer 60

New Drug

Question 61

A drug is not considered a New Drug when there is only a change is previously approved formulation or method of manufacture constitutes newness since such change can alter effects and safety of a product.

Answer 61

False.

Question 62

A drug is not considered a New Drug when there is only a change is previously approved formulation or method of manufacture constitutes newness since such change can alter effects and safety of a product.

Answer 62

False. New Drug is a change is previously approved formulation or method of manufacture constitutes newness since such change can alter effects and safety of a product.

Question 63

``` A proposed new use for an established drug, a new dosage regimen or schedule, a new route of administration, or a new dosage form leads to a drug’s status new and triggers reconsideration for safety and efficacy. ```

Answer 63

New Drug