Drug Development Flashcards
An agent used in the diagnosis, mitigation,
treatment, cure, or prevention of diseases in
humans and animals.
Drug
Greek physician who is
credited with the
introduction of scientific
pharmacy and medicine.
Hippocrates
Hippocrates is known as the ______
Father of Medicine
Established the Theory of Humoral Pathology
Hippocrates
Greek physician, botanist, and Pharmacologist who dealt with botany as an applied science of Pharmacy
Pedanius Dioscorides
Work of Pedanius Dioscorides which served as a milestone in the development of pharmaceutical botany and pharmacognosy.
De Materia Medica
Swiss physician and chemist who
introduced chemical science from the
traditional botanical science.
Aureolus Philipus Theophrastus Bombastus von Hohenheim (Paracelsus)
A Swedish Pharmacist who discovered Oxygen a year before
Priestley.
Karl Wilhelm Scheele
German pharmacist who isolated morphine
from opium.
Friedrich Serturner
He independently isolated codeine from opium
Pierre Robiquet
They isolated quinine and cinchonine from
cinchona.
Joseph Caventou and Joseph Pelletier
Discovered strychnine and
brucine from Nux vomica.
Joseph Caventou and Joseph Pelletier
Isolated caffeine
Pierre Robiquet and Joseph Pelletier
The scientific basis for drug products
to ensure uniformity and quality
leading to the development and
publication of monographs.
Drug Standards
The term pharmacopoeia comes from the
Greek word “_______” (drug) and
“_______” (to make).
Pharmakon
Poiein
Present official standard of Purity, Strength,
Quality, and Analysis of drugs
Pharmacopeia
Contains drug
monographs which assured availability
of quality drugs and pharmaceutical
products.
Official Compendia
The first American pharmacopeia published
in 1778 at Lititz, Pennsylvania.
Lititz Pharmacopeia
Lititz Pharmacopeia was a 32-page booklet consisting of __
internal and __ external drugs and
preparations.
84 internal and 16 external drugs
The Father of USP
Dr. Lyman Spalding
When was the first USP published in English and Latin
December 15, 1820
The first USP was a 272-
page and ___ drugs were listed in it.
217 drugs
T/F : At first, the revision of USP was every 10
years but was decided to revise it every 5
years (1940).
True
In 1888, the first National Formulary was
published under the title ____________
“National
Formulary of Unofficial Drugs”.
T/F: In 1975, US pharmacopoeial convention purchased NF.
True
T/F: In 1980, the first combined compendium
(USP-NF) was published.
True
T/F: In 1864, the first English
Pharmacopoeia was published
False. In 1864, the first British Pharmacopoeia was published.
Contents of the Monograph
- Official Title (Generic Name)
- Graphic or Structural Formula
- Empirical Formula
- Molecular Weight
- Established Chemical Names
- Chemical Abstracts Service (CAS) Registry
Number - Chemical Purity- In terms of percentage
- Cautionary Statement
- Packaging
- Storage
- Chemical and Physical Tests
- Method of Assay
Other References to Drug Standards:
• Homeopathic Pharmacopoeia of the United
States (HPUS)
• International Pharmacopoeia/
Pharmacopeia Internationalis (Published by
WHO)
• BP
• EP
Sources of New Drugs
- Plant Kingdom
- Animal sources
- Microbiological world
- Biological Source
An animal source developed from vampire bat
saliva to treat heart attacks and strokes in
humans
Draculin
For thyroid extract, insulin and pituitary hormone (Replacement Therapy).
Endocrine glands of cattle, sheep, and swine
Source of Estrogen
Urine of pregnant mares
Serums, Anti-toxins, and Vaccines
Biological Sources
Who discovered the smallpox vaccine in England in 1976?
Edward Jenner
Characteristics of Goal Drug
• 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
Drug Discovery
• 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
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.
In Vitro Test
Subsequent bioassay by
biological experiment or technique carried
out within a living organism
In Vivo Test
20 to 80 healthy volunteers
Phase 1
100 to 300 patient volunteers
Phase 2
1000 to 3000 patient volunteers
Phase 3
Laboratory and animal studies
Pre-clinical testing
The phase which determines safety and
dosage, and Bioavailability of the drug
Phase 1
Evaluate
effectiveness,
look for side
effects
Phase 2
Verify effectiveness,
monitor adverse
reactions from longterm
use
Phase 3
Assess
safety and
biological
activity
Pre-clinical testing
Pre-clinical studies
- Chemical and Physical Characterization
- Pharmacology
- Pharmacokinetics
- Pharmacodynamics
- Pharmaceutics
- Analytical studies
- Toxicology
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.
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.
Parties are aware of
the agents’ identities that will be
administered to them.
Open Label Studies
T/F: NDA is submitted to the FDA for review and
approval after the completion of the clinical
trials and requirements have been met.
True
The Post Marketing Studies and manufacturing scale-up
activities take place.
Phase IV
Increase in the batch size from
the clinical batch, submission batch, or to
the full-scale production batch size, using
the finished, marketed product.
Scale Up
T/F: In Phase 4, product development can not be continued.
False. Product development may continue.
Filed for generic copies by competing
companies following expiration of patent
term protection.
ANDA or Abbreviated New Drug Application
There are changes in
synthesis, formulation, analytical standards,
containers, and labeling of drug products.
SNDA or Supplemental New Drug Application
A prototype chemical compound that has a
fundamental desired biologic or pharmacologic activity.
Lead Compound
T/F: Since most drugs have primary and secondary effects, taking advantage of
secondary effects leads to a drugs secondary indication.
True
A compound that requires metabolic
biotransformation after administration to
produce the desired pharmacologically
active compound.
Prodrugs
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.
New Drug
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.
False.
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.
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.
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.
New Drug
