WEEK 4 (CHAPTER 2) Flashcards
as regulated through Title 21 of the U.S. Code of Federal Regulations
requires a new drug to be approved by the Food and Drug Administration (FDA) before it may be legally introduced in the interstate commerce
- ## the regulations apply to the drug products manufactured domestically and those imported into the United States.
Federal Food, Drug, and Cosmetic Act
formerly the Bureau of Food and Drugs or
(BFAD)
- was created under the Department of
Health to license, monitor, and regulate
the flow of food, drugs, cosmetics, medical
devices, and household hazardous waste
in the Philippines
- main goal is to ensure the health and
safety of food and drugs made available
to the public.
Food and Drug Administration
(Philippines)
AN ACT TO ENSURE THE SAFETY AND
PURITY OF FOODS AND COSMETICS, AND THE PURITY, SAFETY, EFFICACY AND QUALITY OF DRUGS AND DEVICES BEING MADE AVAILABLE TO THE PUBLIC, VESTING THE BUREAU OF FOOD AND DRUGS WITH AUTHORITY TO ADMINISTER AND ENFORCE THE LAWS PERTAINING THRETO, AND FOR
OTHER PURPOSES.
Republic Act No. 3720 “Foods, Drugs,
Devices and Cosmetics Act” as amended by E.O. 175
- product’s approved labeling
- summary of the entire drug development
process - it contains the essential chemistry, pharmacology, toxicology, indications and contraindications for use, adverse effects, formulation composition, dosage, and storage requirements
- as ascertained during the research and
development (R&D)
Special Regulations
a special protocol that may be issued permitting the use of an investigational drug to treat some patients prior to approval of the NDA
if there are no satisfactory approved drugs or treatment
alternatives for a serious medical condition often are sought for orphan drugs, which are targeted for small numbers of patients who have rare conditions or diseases for which there are no satisfactory alternative treatments
Treatment Investigational New Drug
a pharmaceutical that remains
commercially undeveloped owing to
limited potential for profitibility
ORPHAN DRUG
- (Brand name: Doxil®)
- Manufactured by Ortho Biotech
- FDA-approved indication: Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinium-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months
Doxorubicin HCL liposome
- (Brand name: Droxia®) - Manufactured by Bristol-Myers Squibb Pharmaceutical
Research Institute - FDA-approved indication: To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the
preceding 12 months).
Hydroxyurea
is used to gain approval to market a
generic equivalent of a product that is
already approved and being marketed by
the pioneer, or the original sponsor, of the
drug
Abbreviated New Drug Application
(ANDA)
such as human blood products and vaccines, which require approval of
a biologics licensing application (BLA) for distribution
Biologics
- which may require an investigational new animal drug application
(INADA) - a new animal drug application (NADA)
- or a supplemental new animal drug application (SNADA)
Animal drugs
cumulative body of scientific and
biomedical information generated
worldwide in research institutes, academic
centers, and industry
DRUG DISCOVERY and
DRUG DESIGN
the antibiotic that became commercially
available in 1944, 15 years after its
discovery in England by Sir Alexander
Fleming and 1 year before the end of the
war.
Penicillin
- Presently it is the fastest growing segment
within the new prescription drug market - advance development which
transforms the treatment of many
diseases - including monoclonal antibodies
- therapeutic proteins
- immunotherapies
- vaccines
Biologic Drugs
- plant drug
- chemical reserpine
- a tranquilizer
- hypotensive agent
Rauwolfia serpentina
- plant drug
- was first scientifically investigated as an
agent useful in the treatment of diabetes mellitus - extracted two potent drugs that
exhibited antitumor capabilities
» vinblastine and vincristine
» used successfully in the treatment of certain types of cancer, including acute
leukemia, Hodgkin disease, lymphocytic lymphoma, and other malignancies
Periwinkle (Vinca rosea)
- prepared from an
extract of the Pacific
yew tree (Taxus brevifolia) - treatment of ovarian cancer.
Paclitaxel (Taxol)
- may have a slightly or vastly different pharmacologic activity from that of the starting substance, depending on the nature and extent of chemical alteration.
- Other plant constituents that in
themselves may be inactive or rather
unimportant therapeutically may be
chemically modified to yield important
drugs with profound pharmacologic
activity. - For example, the various species of
Dioscorea, popularly
known as Mexican yams, are rich in the chemical steroid structure from which cortisone and estrogens are semisynthetically produced.
Semisynthetic Drugs
have served humans in their search for drugs in a number of ways
ANIMALS
such as thyroid extract, insulin,
and pituitary hormone
obtained from the endocrine glands of
cattle, sheep, and swine
lifesaving drugs used daily as replacement therapy in the human
body.
HORMONAL SUBSTANCES
- is a rich source of estrogens (urine)
- used as oral contraceptives
PREGNANT MARES