1-27 Flashcards by San Felipe Michael Josh

Dosage formulations used for clinical evaluation of a newdrug

Clinical Drug Materials

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CTM

Clinical Drug Materials

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Protects the right & safety of the subjects

Investigation New Drug (IND)

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IND

Investigation New Drug (IND)

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ensures investigational plan is sound & designed to achieve the stated objectives

Investigation New Drug (IND)

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Gains permission to market the drug product

New Drug Application (NDA)

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NDA

New Drug Application

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Application by the sponsor of approved NDA to make changes

Supplemental New Drug Application (SNDA)

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SNDA

Supplemental New Drug Application (SNDA)

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Nonclinical laboratory studies & clinical investigations may be omitted, except those pertaining to the drug’s bioavailability

Abbreviated New Drug Application (ANDA)

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ANDA

Abbreviated New Drug Application (ANDA)

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Manufacture of biologicals (blood products, vaccines, & toxins)

Biologics License Application (BLA)

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BLA

Biologics License Application

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Brings together regulatory requirements

International Conference on Harmonization (ICH)

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establishes (long range goal) a uniform set of standards
for drug registration within geographic areas

International Conference on Harmonization (ICH)

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ICH

International Conference on Harmonization (ICH)

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active ingredient/component that produces pharmacologic activity

Drugs Substance

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Enumerate how is drugs substance produced by?

chem. synthesis
enzymatic reaction
recovery from a natural product
recombinant DNA tech.
fermentation
combination of these processes

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Purification needed before use in a drug product

Drug Susbtance

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drug substance with unknown clinical, toxicologic, physical & chem. properties

NEW CHEMICAL ENTITY (NCE)

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NCE

NEW CHEMICAL ENTITY (NCE)

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finished dosage form (containing the drug subs. + other
excipients/inert substances)

Drug Product

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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

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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

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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