Drug Development Process Flashcards
Dosage formulations used for clinical evaluation of a new drug
Clinical Drug Materials (CTM)
Protects the right and safety of the subjects and ensure investigational plan is sound and designed to achieve the stated objectives
Investigational New Drug (IND)
Gains permission to market drug product
New Drug Application (NDA)
Application by the sponsot of approved NDA to make changes
Supplemental New Drug Application (SNDA)
Nonclinical laboratory studies and clinical investigations may be omitted, except those pertaining to the drug’s bioavailability
Abbreviated New Drug Application (ANDA)
Manufacture of biologicals (blood products, vaccines, and toxins)
Biologics License Application (BLA)
It brings together regulatory requirements and establishes (long range goal) a uniform set of standards for drug registration within geographic areas
International Conference on Harmonization (ICH)
Active ingredient or component that produces pharmacologic activity and the purification needrd before use in a drug product
Drug substance
Production processes of drug substance
Chemical synthesis, enzymatic reaction, recovery from a natural product, recombinant DNA technology, and the combination of said processes
Drug substance with unknown clinical, toxicologic, physical and chemical properties
New Chemical Entity (NCE)
Finished dosage form containing drug substance plus other excipients or inert substances
Drug product
Pharmaceutical products that pertain to chemical compounds or biological substances, other than food.
Drugs
Intended use of drugs
Treatment, prevention, cure, or diagnosis of disease in humans or animals
Sources of drugs
Plant, animal, mineral, microbiological, synthetic and semi-synthetic, genetic engineering sources
Source for the conversion of botanic folklore remedies into modern wonder drugs
Plant sources
Uses of Rauwolfia serpentina
Chemical reserpine, tranquilizer, and as a hypotensive agent
Uses of Vinca rosea
Antidiabetic agent and antitumor activity
Uses of Vitex negundo
Anti-inflammatory and bronchial smootg muscle relaxant
Uses of Magostana garcinia
Treatment for skin infections, wounds, dysentery, and urinary tract infections
Provided drugs that are mannered from their tissues or through their biologic processes
Animal sources
Insulin source
Pancreas
Hormone for regulating diabetes
Insulin
It is from the urine of pregnant women and is used for treating infertility
Human chorionic gonadotropin
Source of thyroxin used in hypertension
Sheep thyroid
Vitamins that are sourced from cod liver
Vitamin A and D
Sourced from anterior pituitary and is used for treating infertility
Pituitary gonadotropins
Usage of animal blood
Preparation of vaccines
Digestive juices from stomach tissues used for treating peptic diseases in the past
Pepsin and trypsin
Treatment for iron-deficiency anemia
Iron
Treatment for iron-deficiency anemia
Iron
Mineral used to treat syphillis
Mercurial salts
Mineral used in treating wounds and eczema
Zinc oxide paste
It is used as an antiseptic
Iodine
Used in treating rheumatoid arthritis
Gold salts
Minerals that have antiseptic properties
Fluorine and borax
Used in anti-dandruff shampoos
Selenium
Mineral used in the preparation of liquid paraffin
Petroleum
Inclusions in microbiological sources
Serums, antitoxins, and vaccines
Person who worked on smallpox vaccine
Edward Genner, 1796
Renal monkey vaccine
Poliomyelitis vaccine
Chick embryo vaccine
Mumps and influenza vaccine
Duck embryo vaccine
Rubella (German measles) vaccine
A microbiological source of penicillin
Penicillin notatum fungus
Streptomycin microbiological source
Actinobacteria
Source of aminoglycosides such as gentamicin and tobramycin
Streptomycis and micromonosporas
Synthetic sources
When the nucleus of drug is obtained from natural source as well as its chemical structure is altered
Example of synthetic source
Emetine Bismuth synthetic
Semi synthethic sourcee
When the nucleus of the drug obtained from natural source is retained but the chemical structure is altered
Example of semi synthetic source
Apormorphine, diacetyl morphine, ethinyl estradiol, homatropine, ampicillin, and methyl testosterone.