1-27 Flashcards
Dosage formulations used for clinical evaluation of a newdrug
Clinical Drug Materials
CTM
Clinical Drug Materials
Protects the right & safety of the subjects
Investigation New Drug (IND)
IND
Investigation New Drug (IND)
ensures investigational plan is sound & designed to achieve the stated objectives
Investigation New Drug (IND)
Gains permission to market the drug product
New Drug Application (NDA)
NDA
New Drug Application
Application by the sponsor of approved NDA to make changes
Supplemental New Drug Application (SNDA)
SNDA
Supplemental New Drug Application (SNDA)
Nonclinical laboratory studies & clinical investigations may be omitted, except those pertaining to the drug’s bioavailability
Abbreviated New Drug Application (ANDA)
ANDA
Abbreviated New Drug Application (ANDA)
Manufacture of biologicals (blood products, vaccines, & toxins)
Biologics License Application (BLA)
BLA
Biologics License Application
Brings together regulatory requirements
International Conference on Harmonization (ICH)
establishes (long range goal) a uniform set of standards
for drug registration within geographic areas
International Conference on Harmonization (ICH)
ICH
International Conference on Harmonization (ICH)
active ingredient/component that produces pharmacologic activity
Drugs Substance
Enumerate how is drugs substance produced by?
- chem. synthesis
- enzymatic reaction
- recovery from a natural product
- recombinant DNA tech.
- fermentation
- combination of these processes
Purification needed before use in a drug product
Drug Susbtance
drug substance with unknown clinical, toxicologic, physical & chem. properties
NEW CHEMICAL ENTITY (NCE)
NCE
NEW CHEMICAL ENTITY (NCE)
finished dosage form (containing the drug subs. + other
excipients/inert substances)
Drug Product
refer to pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use in the treatment,
prevention, or diagnosis of disease in humans or animals,
Drugs
Any article recognized in the official United States
Pharmacopeia/National Formulary, Homeopathic Pharmacopeia of
the United States of America, Philippine Pharmacopeia, Philippine
National Drug Formulary, British Pharmacopoeia, European
Pharmacopoeia, Japanese Pharmacopoeia, and any official
compendium or any supplement to them
Drugs
Any article intended for use in
diagnosis, cure, mitigation, treatment, or
prevention of disease of man or animals;
Drugs
Any article, other than food, intended
to affect the structure or any function of
the human body or animals;
Drugs
Any article intended for use, as a
component of articles, specified in
clauses (1), (2) and (3), not including
devices or their components, parts and accessories; and
Drugs
Herbal or Traditional drugs are defined as?
Republic Act No. 9502
Enumerate Sources of Drugs
Plant Sources
Animal Sources
Mineral/Earth Sources
Microbiological Sources
Synthetic/ Semi-synthetic sources
Genetic Engineering
Plant materials have served as a
reservoir of potential drugs
Plant Sources
Conversion of botanic folklore
remedies into modern wonder drugs
Plant Sources
After isolation and structural
identification of active plant
constituents, it maybe recreated by
total synthesis
Plant Sources
Make use of the natural chemical as
the starting material and modified
them through molecular manipulation
Plant Sources
- Chemical
reserpine - Tranquilizer
- Hypotensive
agent
Rauwolfia serpentina
- Periwinkle
- Antidiabetic
agent - Antitumor
activity
Vinca rosea
- Lagundi Leaves
are considered
aromatic, bitter,
anti-inflammatory,
and bronchial
smooth muscle
relaxant
Vitex negundo
- Used to
treat skin
infections,
wounds, dysent
ery, and urinary
tract infections
Mangostana garcinia
Drug testing and biologic assay
Animal Sources
Provided drugs that are mannered from their tissues or through their biologicprocesses
Animal Sources
used in treatment of Diabetes.
Insulin
used for the treatment of infertility.
human chorionic gonadotropin
used in hypertension.
thyroxin,
used as a source of vitamin A and D.
Cod Liver
a source of pituitary gonadotropins, used in treatment of infertility.
Anterior Pituitary
used in preparation of vaccines.
Blood of animals
used in treatment of peptic diseases in the past.
Stomach tissue contains pepsin and trypsin,
used in treatment of iron deficiency anemia.
Iron
are used in Syphilis
Mercurial salts
used as zinc supplement.
zinc
used in wounds and in eczema.
Zinc oxide paste
It is antiseptic and can be used as supplements
Iodine
used in the treatment of rheumatoid
arthritis.
Gold Salt
used in preparation of liquid paraffin.
Petroleum
is used in anti dandruff
shampoos.
selenium as selenium sulfied
Include serums, antitoxins and vaccines
Microbiological sources
who works on smallpox vaccine during 1796?
Edward Genner
Poliomyelitis vaccine
Renal monkey
Mumps & Influenza vaccine-
Chick embryo
Rubella (German measles) vaccine-
Duck embryo
is a fungus which gives penicillin.
Penicillium notatum
give Streptomycin.
Actinobacteria
are obtained from streptomycis and micromonosporas.
Aminoglycosides such as gentamicin and tobramycin
When the nucleus of the drug from natural source as well as its
chemical structure is altered
Synthetic Drug
When the nucleus of drug obtained from natural source is retained but the chemical structure is altered,
Semi Synthetic Source
Emethic Bismuth Iodide
Synthetic Source
Apomorphine
Semi Synthetic Sources
Diacetyl morphine,
Semi Synthetic Sources
Ethinyl Estradiol,
Semi Synthetic Sources
Homatropine,
Semi Synthetic Sources
Ampicillin
Semi Synthetic Sources
Methyl testosterone.
Semi Synthetic Sources
Antianxiety drugs and anti convulsant drugs are in what forms?
Synthetic forms
Recombinant DNA & monoclonal antibody
Genetic Engineering
GENE THERAPY
Genetic Engineering
Enumerate two things you could do in genetic engineering?
Recombinand DNA and monoclonal antibody
Gene Therapy
involves cleavage of DNA by
enzyme restriction endonucleases. The desired gene is
coupled to rapidly replicating DNA (viral, bacterial or
plasmid). The new genetic combination is inserted into the
bacterial cultures which allow production of vast amount of
genetic material.
Recombinant DNA & monoclonal antibody
Is a medical intervention based on the modification of the
genetic material of living cells
Gene Therapy
Enumerate the characteristics of a goal drug
Specifically desired effect,
Administered by the most desired route (generally orally)
at minimal dosage and dosing frequency
Optimal onset and duration of activity
Exhibit no side effects
Eliminated in the body efficiently and completely
Low cost
Pharmaceutically elegant
Physically & chemically stable
Are chemical compounds that show desired biological or
pharmacological activity and may initiate the
development of a new clinically relevant compound.
LEAD COMPOUND
are typically used as starting points in drug design to give new drug entities.
LEAD COMPOUND
Drug design strategies can be used to improve the
compound’s pharmacodynamic and pharmacokinetic
properties.
Lead compound
Treatment IND are sought for to target small number of
patients with rare conditions/diseases (orphan diseases)
where there are no satisfactory alternative treatments
Orphan drug
Rare disease/condition affecting fewer than 200,000
people:
Orphan Disease
Enumerate examples of some orphan disease
Chronic lymphocytes
Gaucher’s Disease
Leukemia
Cystic Fibrosis Aids
as a chemical that is transformed before it has
pharmacological effects.
Prodrug
Before a prodrug can provide its intended effects in your body,
it needs to be?
broken down
drug becomes actibe after metabolism
Pro drug
What are two major types of prodrugs
Type I prodrug
Type II prodrug
prodrugs turn into their active forms inside of cells.
Type I
prodrugs turn into their active forms outside of cells, such
as in blood or other fluids.
Type II
is defined by FDA as an active
ingredient that has never before been marketed in any form.
New Molecular Entity (NME)
NME
New Molecular Entity (NME)
A change in a previously approved drug product’s formulation
or method of manufacture constitutes newness under the
law such as changes can alter the therapeutic efficacy
and/or safety of a product.
New Molecular Entity (NME)
A proposed new use for an established drug, a new dosage
schedule or regimen, a new route of administration, or a
new dosage form makes a drug or a drug product’s status
new and triggers reconsideration for safety and effficacy
New Molecular Entity (NME)
indicates the number and relationship pf
the atoms in the molecule
Empirical formula-
name of the compound’s every part of molecular structure
Chemical name
C16H19N3O3S.3H2O
Amoxicillin empirical formula
(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-
hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic acid
Amoxicillin Chemical name
non-propriety name of the drug, serves to identify the substance to which is applies by means of a
designation that maybe used by the professionals, refers to
the active ingredient of the drug.
Generic Name
trademarked name/ marketed name assigned by the producing company
Brand name
