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BioDefinitions:
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A
Antibody
Antibodies are formed when an immune system reacts to
a foreign substance and creates a molecule that recognizes that foreign
substance. This antibody then binds to the foreign material and activates
the immune system to fight the foreign substance. |
ASP
Application Service Provider: |
Autoradiography
Autoradiography is a sensitive and simple method of recording
spatial distribution of radioisotope-labeled substances within a specimen
material. The radioisotopic emissions release energy to the sensitive silver
halide grains in the emulsion layer of the photographic film, thus forming
a latent image. When treated with a developing agent , the autoradiograms
yield visible density images which can be observed by the eye or measured
by a densitometer for precise analysis (1). Radioisotope-labeled samples
can be detected on polyacrylamide or agarose gels, nylon or nitrocellulose
membranes, or thin layer chromatography plates. Autoradiography is widely
used by scientists and researchers in the analysis of chemical mixtures,
recombinant DNA techniques applied to genetic marker mapping, genomic sequencing,
drug screening and plant fertilization studies.
(1) Hahn E.J., American Laboratory 15: 64-71, 1983
Source: Spectronics Corp. Click for their site: www.spectroline.com
|
B
Base Pair bp
Two DNA sub units bound together by
weak biochemical bonds between their nitrogen containing components. The
base guanine pairs with cytosine creating the GC or CG base pair. And the
base adenine pairs with thymine creating the AT or TA configuration. The
chemical bonds between multiple base pairs holds the two strands of DNA
material together. The shape has been described as a double helix. |
Brand Loyalty
Brand loyalty of current clients is a critical asset
that must be managed carefully. This loyalty is a major barrier to competition.
Countless new business have succeeded because companies neglected existing
customers. If properly managed brand loyalty can result in: lower
marketing costs, more time to respond to competitive threats and attracting
new clients. |
Branding Awareness Pyramid
The Branding Awareness Pyramid is a well established
marketing research tool. The purpose of this concept is two-fold. First,
through various research techniques, phone, mail, fax, etc. the researcher
determines where the company's brand awareness lies on
the pyramid. Secondly, once quantified, the company can establish goals
for moving the market awareness up the pyramid. The pyramid consists of
the following elements:
Top
of Mind
Brand Recall
Brand Recognition
Unaware of the Brand
|
C
Clinical Trials: Phases
Clinical Trials are generally categorized into four (sometimes
five) phases. An investigational medicine or product may be evaluated in
two or more phases simultaneously in different trials, and some trials
may overlap two different phases.
Phase 1:
Initial safety trials on a new medicine in which investigators
attempt to establish the dose range tolerated by about 20-30 healthy volunteers
for single or multiple doses. Although usually conducted with healthy volunteers,
Phase 1 trials are sometimes conducted with severely ill patients, for
example those with cancer or AIDS. When pharmacokinetic issues are being
addressed (for example,
metabolism of a new antiepileptic medicine on stable
epileptic patients whose microsomal liver enzymes have been induced by
other antiepileptic medicines), trials may be conducted in less ill patients.
Pharmacokinetic trials are usually considered Phase 1 trials regardless
of when they are conducted during a medicine's development.
Phase 2a:
Pilot clinical trials to evaluate efficacy and safety
in selected populations of about 100 to 300 patients who have the disease
or condition to be treated, diagnosed or prevented. often involve hospitalized
patients who can be closely monitored. Objectives may focus on dose-response,
type of patient, frequency of dosing, or any of a number of other issues
involved in safety and efficacy.
Phase 2b:
Well controlled trials to evaluate safety and efficacy
in patients who have the disease or condition to be treated, diagnosed
or prevented. These trials usually represent the most rigorous demonstration
of a medicine's efficacy. Synonym: pivotal trials.
Phase 3:
Multicenter studies in populations of 1000 to 3000 patients
(or more)
for whom the medicine is eventually intended. Phase 3
trials generate additional safety and efficacy data from relatively large
numbers of patients in both controlled and uncontrolled designs and are
used to support a PLA (Product License Application). Trials are also conducted
in special groups of patients or under special conditions dictated by the
nature of the particular medicine and/or disease. Phase 3 trials are often
provide much of the information needed for package insert and labeling
of the medicine.
Phase 3b:
Trials are conducted after submission of a new drug application
(NDA), but before the product's approval for market launch. Phase 3b trials
may supplement or complete earlier trials, or they may seek different kinds
of information (for example, quality of life or marketing). Phase 3b is
the period between submission for approval and receipt of marketing authorization.
Phase 4
After a medicine is marketed, Phase 4 trials provide
additional details about the product's safety and efficacy. They may be
used to evaluate formulations, dosages, durations of treatment, medicine
interactions, and other factors. Patients from various demographic groups
may be studied. An important part of many Phase 4 studies is detecting
and defining previously unknown or inadequately quantified adverse reactions
and related risk factors. Phase 4 studies that are primarily observational
or non experimental are frequently called post marketing surveillance.
Phase 5:
Post marketing surveillance is sometimes referred to
as Phase 5.
Source: Applied Clinical Trials/Advanstar. Click for their
site: www.advanstar.com
|
CFR
The Code of Federal Regulations are the codified regulations
borne of the laws of the United States Federal Government. Comprised of
over fifty titles, Title 21 is entitled Food and Drugs, and prescribes
the procedures to be followed by companies and individuals in the food
and drug business. To access the actual code directly from the U.S. Government
click here. |
Chromosome
One of a set of threadlike structures, composed of DNA
and a protein, that form in the nucleus when the cell begins to divide
and that carry the genes which determine a persons genetic heredity.
We have 23 pairs of chromosomes, each composed of DNA sub units whose sequence
determines our entire array of genes. |
Clinical
Research Associate (CRA)
Person employed by a sponsor, or by a contract research
organization (CRO) acting on a sponsor's behalf, who monitors the progress
of investigator sites participating in a clinical study. At some (primarily
academic) sites, clinical research coordinators are called CRA's.
Source: Applied Clinical Trials/Advanstar. Click
for their site: www.advanstar.com
|
Cloning
The process of producing, exact copies of a single gene,
other DNA segments, an entire cell or a complete organism. Cloned collections
of DNA are called clone libraries and are useful tools in helping scientists
piece together our genetic information. |
Computed Radiography
(CR)
Is a technology that Fujifilm pioneered and began marketing
in the early1980s, is a system that brings the power of computers to image
acquisition, processing, display and management.
Advantages of CR
Virtual elimination
of the need for re-takes.
Elimination of lost
images.
Simplification in
the filing of images.
Increased capability
for consultation made
possible by electronic
transmission of digital
images.
Source: Fujifilm Medical Imaging. Click for their site:
www.fujimed.com/medical/medical.html
|
D
Declaration
of Helsinki
A set of recommendations or basic principles that guide
medical doctors in the conduct of biomedical research involving human subjects.
It was adopted by the 18th World Medical Assembly (Helsinki, Finland 1964)
and revised by the 29th (Tokyo, Japan 1975) and 35th (Venice, Italy 1983).
The full text is in Title 21 CFR 312.120 (Code
of Federal Regulations), in an appendix to the Nordic Council on Medicines
Guidelines for Good Clinical Practice, and in other reference materials.
Source: Applied Clinical Trials/Advanstar. Click
for their site: www.advanstar.com
|
DNA
An abbreviation for deoxyribonucleic acid.
The long, double stranded molecule coiled inside each cell consists of
individual subunits called nucleotides
that spell-out our genetic information. James Watson and Francis Crick
published a paper in 1953 demonstrating the double-helix structure of DNA.
Their paper concluded with the scientific understatement of the millennium,
"..this structure (DNA) has novel features, which are of considerable biological
interest." |
E
Endpoint
An indicator measured in a subject or biological sample
to assess the safety, efficacy, or other objective of a trial.
See also Surrogate
Marker.
Source: Applied Clinical Trials/Advanstar. Click
for their site: www.advanstar.com
|
Enterprise Information Portal (EIP)
EIP's are internet communities dedicated to providing
a mutually beneficial relationship to both its partners and end-users by
carrying strategic content and applications from leading providers. Partners
benefit from increasing their exposure to an expanded base of potential
customers, while end-users enjoy the ease of access and integration of
vital business content and business applications. |
Equipose
A state in which an investigator is uncertain about which
arm of a clinical trial would be therapeutically superior for a patient.
An investigator who has a treatment preference or finds out that one arm
of a comparative trial offers a clinically therapeutic advantage should
disclose this information to subjects participating in the trial.
Source: Applied Clinical Trials/Advanstar. Click
for their site: www.advanstar.com
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