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C
Cardiology
The study of diagnosis and treatment of disorders of
the heart and blood vessels
www.dcri.duke.edu/patient/glossary.jsp |
Cheshire Labels
4 Up (4 Across) labels that are made of paper. When a
mailer orders these they are generally provided at no charge. The mailer
needs a special machine that separates and adheres these labels to their
mail piece. Also, paper that has printed names and addresses which are
to be mechanically affixed individually to each mailing piece. The types
of paper include fanfold, accordion fold, etc. |
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
Product/Service Category: Clinical
Services, Contract Services Sub Category: Clinical
Trial Mgmt Phase l, Validation-Clinical
Suggested Reading:
Analysing Survival
Data from Clinical Trials and Observational Studies
Clinical Trials :
A Methodologic Perspective
Improving R & D Performance
the Juran Way
Suggested Trade and Journal Publications:
Applied Clinical Trials,Contract
Pharma, Pharmaceutical Executive,R
& D Magazine |
Community Health
Or public health is an aspect of health services concerned
with threats to the overall health of a community based on population health
analysis.
www.dictionaryofeverything.com/explore/957/Medicine.html |
CRO, Contract Research Organization
This term applies to a type of organization that offers
their clients a wide range of pharmaceutical research services. These services
include; product development and formulation, clinical trial management-preclinical
through phase IV, central laboratory services for processing trial
samples, data management services for preparation of an FDA
New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA),
and many other complementary services. The primary benefit CROs offer their
clients is the experience of moving a new drug from its conception to FDA
marketing approval.
Product/Service Category: Clinical
Services, Contract Services Sub Category: Clinical
Trial Mgmt Phase l,
Suggested Reading:
Clinical Trials :
A Methodologic Perspective
Improving R & D Performance
the Juran Way
Suggested Trade and Journal Publications:
Applied Clinical Trials,Contract
Pharma, Pharmaceutical Executive,R
& D Magazine |
Cosmetic Surgery
The term "Cosmetic Surgery" means medically unnecessary
surgical procedures, usually, but not limited to, plastic surgery directed
toward preserving beauty.
www.wwcta.org/ins7-def.htm |
Critical Care
Critical healthcare provided to a critically ill patient
during a medical emergency or crisis.
www.hc-sc.gc.ca/english/organandtissue/glossary/ |
| Customer Relationship Management
(CRM)
Customer Relationship Management, which places the customer's
needs first, involves two different steps: first, deeply understanding
your customers, and secondly, aligning the organization's capabilities
in order to better deliver value to customers. (Andersen
Consulting, Mr. Dale Renner).
Customer Relationship Management is the ability to treat
different customers differently. The focus of the 1:1 enterprise is not
to find more customers for it's products, but to find more products for
it's customers, CRM with a customer is not a reward for past transactions,
but an investment in the future, (Peppers and Rogers Group).
Customer Relationship Management, is the integration and
alignment of processes, culture and systems to deliver an organization's
most valuable customers, (White Whale Limited).
Product/Service Category: Marketing,
Media & CRM
Suggested Reading: CRM Conference
Summary-Phila 3/28-3/30/2001
Successful Pharmaceutical
Selling
Drugs to Market : Creating
Value and Advantage in the Pharmaceutical Industry
Pharmaceutical
Marketing in the 21st Century
Pharmaceutical
Marketing : Strategy and Cases
From The CRM Forum
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