Drug
Approval Process in
the USA and Canada
Welcome
to KRC Inc. On-line training!
Who
are we?
Kriger
Research Center Inc. is an organization with broad expertise in
the planning, execution and interpretation of research projects.
As our clients know, KRC Inc. serves as a partner in clinical
research with extensive experience in different phases of
clinical trials. KRC Inc. provides focused, comprehensive
planning, which leads to a successful trial. Beyond the trial, we
remain involved and committed to a development process that is
custom-designed to our clients' needs. We are committed to
investing in ongoing training for our employees to ensure they are
kept on the leading edge of new technologies. These training
initiatives include interactions with academia, attendance at
scientific conferences and meetings, training courses from experts
in various fields, etc.
We have
good working relationships with most reputable clinical research
recruiters such as Kelly Scientific Resources, clinical research
organizations (CRO),
and pharmaceutical companies that recognize us as a reputable
institution. Some of them are posting their openings for clinical
research positions on our site . We have also an affiliated
recruitment agency Biorole Scientific Solutions Inc. All our
graduates are eligible to post their resumes on it's web. based
database www.biorole.com . The
famous recruiter for biopharmaceutical industry Woolf Group is
routinely recommending KRC Inc. training in their e-mails to
unqualified candidates.
Our
Diplomas state that the student has passed a program on
Data Management in clinical Trials, ICH
Good Clinical practice (GCP)
which is a standard requirement in this industry.
The most important benefit of our program is student enrollment
in a volunteer position in real projects that give
essential initial experience in the field. This is what potential
employers like about us because our graduates know exactly what they
are going to do in the industry, and that's what every employer
actually needs.
Most
of KRC Inc. graduates become members of the Association of Clinical
Research Professionals and Society for clinical Data Managers
the industry most recognized organizations.
The
KRC Inc. Programs are recognized by the
Society
for Clinical Data Management
and
KRC is currently in negotiations to become a certification-training
provider for this organization. KRC
invited to send a speaker for the Society’s
Fall Conference. A request was also made at that time for KRC to
provide certification training for the Society for Clinical Data
Management’s Certification Exams.
KRC is listed on the most respected and trusted website for the
Clinical Trials Industry: http://www.centerwatch.com/professional/prv392.html
as a CRO and as a Training
Institution .
KRC
Inc. graduates have been hired by many other industry providers. (AAI
Development Services Clinical Trials Division, Woolf Group , Princess
Margaret Hospital,
University
Health Network )
. Over
half of KRC’s current or previous employees are KRC Inc.
graduates.
All
graduates are involved as volunteers in research activities, are
evaluated by KRC Inc. Practical Projects Coordinators and are
entitled to receive references for their participation. Other
industry providers recognize and accept these references.
Why
would you need this program?
This truly interactive program can
help you gain appropriate knowledge and practical skills in order to
apply for the position of Clinical Research Data Manager . Upon
completion of this program and after passing on-line final
exams you will receive, by mail, a diploma stating your new
qualifications. You will be approved as a clinical research
associate to participate in clinical research projects
at our center. You will be appointed to one of the on-line research
groups working on a specific drug. You will receive individual
clinical research tasks that will give you sufficient
experience to get started on your first job in this field. Modern
clinical research activities are almost entirely based on networking
and internet on-line communications. Your experience in this area
will be most valuable for your future employment. All your tasks you
will be received on-line and will be conducted by you as a
home-based Clinical Research Associate.
You would actively participate in the development
of clinical research data bases, data entry, data analysis,
development of some parts of the protocol, preparing CRF-s (Case
Report Forms), reviewing informed consent forms, networking with
potential investigators, initiating clinical research sites,
monitoring, creating databases, performing data entry and analysis
and many other tasks. You will utilize your knowledge of ICH GCP
(Good Clinical Practice) in each phase of the clinical research. You
will submit your work for approval by e-mail. At the end of your
work you will receive a reference letter stating your new
qualifications and experience with our contract research center. At
this stage you could work with our company as a volunteer. The most
successful participants could be offered employment with our company
upon completion of this program.
There are 65 sessions with many open
ended questions in this program. You move through sessions at your
own pace and submit your answers to the open questions to life
on-line teachers (active researchers of our company involved in real
clinical trials projects). Most of our teaching personnel has a
MSc - PhD level in clinical trials-related areas and have intensive
clinical research experience. Each and every answer to open
questions that you submit receives comments from our on-line
teachers. They will send you additional related articles, you will
submit your feedback on the articles and receive comments if needed.
You will also receive comments on every practical task you submit.
That usually adds up to at least 200-250 communications throughout
the program. Also students ask many questions and they always get a
reply. We review everything that comes to us on-line: answers to
training questions, questions about practical tasks, resumes and we
even give advice to help with your future interviews. We also
prepare reference letters for successful participants in research
projects. The assessment of your performance works like this: We
save all your answers and your comments regarding the additional
articles in special folders under your name. When you finish the
course and pass your on-line final exam we receive notification from
the final page of the course along with your request to issue a
Diploma. We then check your participation in answering the open
questions. If you have answered enough of them - you get your
diploma by mail. If not, we ask you to answer some more questions,
and after you have completed them, you get your Diploma by mail.
It is recommended to save a copy of all your answers in one or
two text files in order to be able to re-submit them if necessary.
Our responsibility is to make sure that a Diploma is issued only to
those who qualify, in other words, have demonstrated his/her
knowledge by answering most of our questions.
Why
are there not enough Clinical Research Data Management Specialists on
the market and why is it important to train the new specialists out of
other professions with the right educational background?
In
fact, the market is currently expanding faster than the production of
new qualified professionals which inevitably creates a demand.
Most people are under the impression that the barriers to enter
this industry are extremely difficult to overcome, but the truth is
that everybody working in this industry had to start somewhere and as
the industry grows positions need to be filled.
Now the question is: how will this be accomplished?
One way of filling the vacuum is to take specialists from other
professions and turn them into professionals for this industry.
This has several added benefits of its own.
For instance bringing specialists from other professions or
industries actually diversifies the workforce and brings new
perspectives to the biopharmaceutical industry.
This in turn is a source of innovation where multiple
disciplines are being united and new perspectives are made more
apparent.
Of course, the need for training is obvious for specialists
that are re-aligning their careers as well as for individuals that are entering the industry as new
graduates. Most of the
skills and knowledge required in positions such as CRA’s, CDM’s,
QA’s and Marketing Managers are not covered in university courses.
Even where an individual has been through a specially
designed training program for the position through an academic
institution, the training may not involve a practical component in
which case the individual still lacks certain skills.
This should re-emphasize the importance of practical training
programs for the biopharmaceutical industry.
The
educational system does not appear to produce enough graduates to meet
the demand for entry level positions like CRA, Data Manager Specialists,
Quality Assurance Specialists and Marketing and Management
specialists. Skill shortages also affect the ability of
regulatory agencies to keep abreast of scientific advances and to
efficiently review the increasing number of new products. The diverse
range of skills required along with the dramatic pace of change is not
reflected in current university courses. The shortage of specialists
could be felt in other areas too. For example, bioinformatics requires
a background in genetics, statistics, and software development, but
most graduates lack such multi-disciplinary training. Also, there are
no Canadian undergraduate degree programs in bioengineering;
specialization options are normally offered within more traditional
programs.
Who
can train Clinical
Research Data Management Specialists ?
How valid is this certification?
At
present, there is no professional designation for the positions
of Clinical Data Manager although these are valid and mid
– high ranking positions in the corporate structure.
The ideal training environment would be in a research company itself
where the trainees can gain access to real practical experience.
Most if not all companies are very reluctant to hire
individuals without any experience, so even 6 months as a volunteer is
usually enough to get oneself into an entry level position.
Certification
is a process by which a non-governmental agency validates, based upon
predetermined standards, an individual's qualifications and knowledge
in a defined functional or clinical area. The issue of being
"certified" is confusing for many people who begin looking
at Clinical Research as a career, for example: "CRA" and
“CRC” are job titles not credentials. They neither imply nor
require "certification". The job function of CRA is not one
that requires any special certification in order to perform it
unlike, say, a CPA (Certified Public Accountant) or CMT (Certified
Massage Therapist). Those are regulated job functions where people
cannot call themselves "CPA" or "CMT" unless they
have gone through specific procedures regulated by a governing body.
However,
many companies use Certificates of Training as a screening mechanism
for hiring or promoting employees. This results in multiple sources of
training for Clinical Research professionals, where the certifications
are tied to the completion of different courses offered by various
training providers.
A
certification offered by a pharmaceutical research company would be
recognized in the industry as a professional development course.
More important than this however, is the reference that backs
the certification. An
individual with a reference from a pharmaceutical company will be held
in a
higher regard than an individual with a reference from an academic
college. In this industry
especially, reputation is very important and goes a long way –
professional references are usually the deal maker or breaker when a
person is considered for a position.
A statistics or database
specialist degree , degrees in computer science or other IT degrees
or life science degrees (especially pharmacology, pharmacy,
biochemistry, immunology, physiology or toxicology) or a nursing degree
is one of the requirements for entry into clinical research data
management work. Other science degrees may be accepted. Some companies
will employ recent graduates with necessary personal skills. As a
graduate with no previous relevant experience you would be more likely
to enter the field at a lower level, e.g. as a clinical data
coordinator. These are generally jobs which deal with the data
handling/co-ordination without the involvement of initiating and
designing the trials. Experience in this type of work would generally
qualify you to move on to other research positions.
In addition to a scientific
or nursing background companies will look for excellent communication
skills (both written and verbal), an ability to get along with people and
an eye for detail. Numeracy, good organizational and administrative
skills are also important. The job requires self-motivation
and an ability to assimilate information quickly. A mature attitude
is essential and mature students with relevant past experience may
have an advantage. The people aspects of this job mean you need
to have an outgoing, confident and friendly personality. You must be
able to understand the importance of good clinical practice (GCP).
Having relevant pre-entry experience is desirable and could include:
statistical work or data management, a medical practice, a
nursing background, medical sales, clinical laboratory work, clinical
data work or pharmaceutical research.
Career
Development
Career structures will
obviously vary from company to company and are not always very clear
cut. However, most companies have clinical trial data
management/executive positions which would be the next step for an
experienced employee. Some companies ask for PhD's in bio. statistics for
senior posts.
Typical
Employers
You would either be employed
directly by a pharmaceutical company or by a contract research
organisation (CRO - agencies which employ clinical research staff to
contract out to pharmaceutical companies). Hospital academic
departments occasionally have the same positions.
Sources of
Vacancies
Kriger Research Center will
provide you with current positions that could be suitable for your
future employment by sending you KRC Inc. Newsletter.
You will have to make
additional efforts in order to succeed. See specialist press for
recruitment agencies or contact your careers service. It may be worth
registering with a specialist recruitment agency. Alternatively
(or in addition,) try approaching pharmaceutical or CRO companies
directly.
Training
The Clinical Research Data
Management and Analysis Course is a summary of duties and
responsibilities of Clinical Data Analysts, Biostatisticians, SAS
Programmers, and Coding Specialists. This course is designed for
statisticians, science teachers, data base specialists, physicians,
pharmacists, biologists, biochemists, microbiologists, nurses, and SAS
Programmers who want to enter the Clinical Research field.
The course begins by
exploring the fundamental and proven techniques of Clinical Trial
Processes, Collection, Management and Reporting of Clinical Study
Data. This comprehensive course provides the essentials of
understanding roles and responsibilities of Clinical Data Analysts,
Biostatisticians, SAS Programmers, and Coding Specialists. It is
followed by a discussion of related Good Clinical Practices and FDA Regulations for
overall compliance. Additional details will be given on the allocation of
Clinical Trials staff members for projects. Attendees will develop
communication and negotiation skills that will enhance the success of
their employment. By the end of this course applicants will gain the
knowledge they need to start a new career in the pharmaceutical
industry.
Upon completion of this
course, participants will be competent and possess the skills
needed in order to manage clinical data in any clinical research
study.
Taking this program could be
a substantial asset for getting an employment position in Clinical
Research. Check clinical positions on our web site - you will see that
enrolling in KRC programs can be valuable towards getting a job. Upon completion
of your study and exams you will receive a Diploma . This program is
exempted from registration under The Private Career Colleges Act and
Regulations, as it is considered a short professional development program. Thus,
it is not scrutinized by the Ministry of Training, Colleges and
Universities, Clinical Research Association or other institutions.
During this course you will receive
frequent email issues of the KRC Inc. Newsletter
which includes current position openings in the
field . In addition, you can get help in your resume
preparation. As a participant of this program you are encouraged to
take part in Kriger Research Center Research projects as a volunteer.
This would enable you to earn appropriate experience.
This on-line program
will help you to gain the appropriate knowledge and
practical skills to apply for the position of Data
Manager . To
complete the program you will need to pass an on-line final exam and
will then receive by mail a diploma stating your new qualifications.
You will then obtain approval as a clinical data coordinator to
participate in the clinical research projects of our center. You will be
appointed to join one of the on-line research groups working on
a specific drug and will receive individual clinical research and data
management tasks that will give you sufficient experience to get
started in your job in this field. Modern clinical research activities
are almost entirely based on networking and internet on-line
communications. Your experience in this area will be most valuable
towards your future employment . You will receive all
tasks on-line and will conduct work as a home-based Clinical
Data Management Position. You will actively participate in the
development of some parts of the protocol, preparing CRF-s (Case
Report Forms), reviewing inform consent forms, networking with
potential investigators, creating databases, performing data
entry and analysis, and many other tasks. You will use your
knowledge of ICH
GCP
(Good Clinical Practice) in each phase of
the clinical research. You will submit your work for approval by e-mail.
At the end of your work you will receive a reference letter stating
your experience and qualifications with our contract research
center. At this stage you would work with our company as a volunteer.
The most successful participants could be offered employment with our
company upon completion of this program.
You can move through
sessions at your own pace and submit your answers to the open
questions to on-line teachers who are active researchers in our company
involved in real clinical trial projects. Some of our teaching
personnel hold PhD's in clinical trial-related areas and have
extensive
clinical research experience. Every answer that you submit
to an open question receives comments from our on-line teachers. They send
you additional related articles, and you submit your feedback to the
articles and receive comments if needed. You will also receive comments to
every practical task you submit. Expect 200-250
communications throughout the program. Students ask many
questions and they always get a reply. We review everything that
comes on-line: answers to training questions, practical tasks. We
review resumes and give advise for future interviews. We prepare
reference letters for successful participants of the research projects.
Performance assessment works as follows: we save
all your answers and your comments regarding the additional articles
in a special folder under your name, and when you get to the end and
finish your on-line final exam we get the message from the final page
with your request to issue the Diploma. Then we check your participation
in answering the open questions. If you have answered most of them -
you get your diploma by mail. If not, we ask you to complete the
questions, and then you get your Diploma by mail. Don't move on
until your answer is accepted. You have to save a copy of all your
answers in one to two text files in order to be able to re-submit them
if necessary. Our responsibility is to make sure that the Diploma
is issued only to those who qualify, in other words, have showed his/her
knowledge by answering most of our questions. Multiple choice
questions at the end of each session serve only as keys to proceed
through sessions.
After training you participate in real research projects. The most
important thing is that you get a reference letter on your project
participation that is adjusted to your needs and reflects appropriate
details of your active participation in these full-scale research projects.
Without proper reference letters it is completely useless to approach
any serious Contract Research Organization or Sponsor (pharmaceutical
company) in order to get a job in Clinical Research. You get perpetual
support from our research center staff when you mention our institution
in your resume as a place where your potential employer could obtain
references. Almost always, a prospective employer makes a call to
collect references through a personal phone conversation. When your
prospective employer calls us for a reference we will be
able to relate all
the details of your research participation and appropriate
qualifications. This could drastically increase your chances to get a
job in Clinical Research . You get active help in your new resume
preparation. Remember, your resume is the first step in being
able to get a job. On average every two weeks you will get a letter from us
that includes current,
exclusive Clinical Research Data Management Positions that you can
apply for. You are most welcome to ask any questions. If we are unable to answer them right away we
will talk to people that work on
study design, protocol development and regulatory affairs and then get
back to you.
Why do we ask open questions?
Because we wish to prepare our students for job interviews with prospective
employers most of our open-ended questions are based on questions asked by employers
during interviews with our previous graduates.
That is why it is so important that you answer each question in
as much detail as you can. In order to make a good impression with a prospective employer you
need to be competent in professional terminology and related concepts. So,
you are encouraged to use this opportunity to prepare yourself for a real job interview by answering our open questions as best as you can.
Clinical trials are about
medicine whether we want it or not. Even though pharmaceutical companies and CRO's
advertise that they want mathematicians, database specialists and statisticians for data management positions, they do expect people
to have a true interest in medicine rather than a formal medical background.
We are here to help you. If there is anything that you don't
understand just ask. There is nothing that cannot be explained.
You will have access to a bonus course in pharmacology and medical terminology
on-line, and a medical slide show. Why not to take advantage of it?
If the IT industry is down, and biotech is up you have to be
willing to be flexible and as open to the job market as possible.
Understanding and true interest in medicine could be more important
than formal medical education in applying for data management positions in clinical trials.
We would like to highlight once again the benefits of your
enrolment in this program:
1. You get the essential
knowledge of all you need in order to apply for the following
positions: Data Manager/Associate, Clinical Data Coordinator (CDC),
Clinical Data specialist (CDS), Clinical Data Analyst, Data Base
Developer, and if you have the appropriate statistical or math background
- Bio Statistician and SAS Programmer. You will learn the most important
principles of Clinical Research Data Management like working with
logical, consistent and complete data. You will get all
necessary materials, interactive, practical, open-ended questions. Upon completion of this program you will
need to pass an on-line final exam and will then receive by mail your diploma stating your
new qualifications .
2. You will receive a specially
designed Diploma stating the program objective "Data Management
in clinical Trials , ICH
GCP
Guidelines, Clinical Trial Monitoring and Research Site
Coordination.". This is an essential requirement in any position
in Clinical Research Data Management .
3. You participate and gain
unique experience in real Clinical Trial Projects
| PROJECT
I |
Efficacy
of the lowering effect of PROLIPOSTAT®
on Blood concentrations of
low-density lipoprotein cholesterol (LDL-C) in patients with
normal and elevated blood concentrations of LDL-C
|
| PROJECT
II |
Phase
II Study the Efficacy of the healing effect of recombinant human
epidermal growth factor (rhEGF) on diabetic foot ulcers
|
| PROJECT
III |
Phase
I Study the safety and Dose determination of Immuno -
Stimulatory Therapy Agent for Bladder cancer, melanoma and colon
cancer. |
| PROJECT
IV |
Survey:
Proper Use and Cost Reduction strategies for prescription and
non-prescription drugs
|
You will be preparing CRF-s
(Case Report Forms), reviewing inform consents forms, networking with
potential investigators, clinical research site initiation ,
monitoring, performing data entry and analysis, and many other tasks.
You will implement your knowledge of ICH
GCP
(Good Clinical Practice)
in each phase of clinical research. Your partner will create a data
base of case report form CRF results using SAS program or simple
spread sheet program. Conduct the double data entry . Your
partner for double data entry would enter the data for the second time
and the data base would find mistakes by verifying validity of the
data entered. You will use real CRF forms . You will
submit your work for approval on-line. At the end of your work you
will receive a reference letter stating your new experience and
qualifications with our contract research center.
4 Any experience in
data management in the research area is crucial in order to get a job in
Clinical Research Data Management.
5. You get reference letters
based on your project participation adjusted to your needs that
reflect the details of your active participation in the full-scale
research projects. Without proper reference letters it is completely
useless to approach any serious Clinical Research Organization or
Sponsor in order to get a job as Clinical Research Associate /
Coordinator.
6 . You get perpetual support
of our research centre staff when you mention our institution in your
resume as a place where your potential employer could obtain
references. Almost always prospective employers make a call to
collect references through a personal phone conversation. When your
prospective employer calls us for a reference we would relate the details of your research participation and appropriate
qualifications. This could drastically increase your chances of getting a
job in Clinical Research Data Management.
7. You get active help in
your new resume preparation. Remember, your resume is the first step
towards getting a job. You can now include on your updated resume your participation in Clinical Research Data Management and
ICH
GCP
Guidelines Seminar and Canadian experience in Data Management
in a real full-scale research project at Kriger Research Center Inc.
8. You get on the average every
two weeks a letter from us including current, exclusive Clinical Research
Data Management Positions that you can apply for right away.
9. You will get a return on
this investment in your education and training at KRC of at
least at 36 times more than you have paid, and this in very first year
of your work in Clinical Research Data Management!
Please, enter your
name, e-mail and telephone to let our on-line instructors
contact you.
Introduction to
Drug Approval Process
in the USA and
Canada
The U.S. and Canadian systems of new drug
approvals are perhaps the most rigorous in the world. On average, it
costs a company $359 million to get one new medicine from the
laboratory to the pharmacist's shelf, according to a February 1993
report by the Congressional Office of Technology Assessment. It takes
12 years on average for an experimental drug to travel from lab to
medicine chest. Only five in 5,000 compounds that enter preclinical
testing make it to human testing. One of these five tested in people
is approved. New medicines are developed as follows:
Synthesis and Extraction The process of identifying new
molecules with the potential to produce a desired change in a
biological system (e.g., to inhibit or stimulate an important enzyme,
to alter a metabolic pathway, or to change cellular structure). The
process may require: 1) research on the fundamental mechanisms of
disease or biological processes; 2) research on the action of known
therapeutic agents; or 3) random selection and broad biological
screening. New molecules can be produced through artificial synthesis
or extracted from natural sources (plant, mineral, or animal). The
number of compounds that can be produced based on the same general
chemical structure runs into the hundreds of millions.
| New
Drug Discovery and approval can take up to 20 years |
Biological Screening and Pharmacological Testing Studies
to explore the pharmacological activity and therapeutic potential of
compounds. These tests involve the use of animals, isolated cell
cultures and tissues, enzymes and cloned receptor sites as well as
computer models. If the results of the tests suggest potential
beneficial activity, related compounds, each a unique structural
modification of the original compound are tested to see which version
of the molecule produces the highest level of pharmacological activity
and demonstrates the most therapeutic promise, with the smallest
number of potentially harmful biological properties.
Pharmaceutical Dosage Formulation and Stability Testing
The process of turning an active compound into a form and strength
suitable for human use . A pharmaceutical product can take any one of
a number of dosage forms (e.g., liquid, tablets, capsules, ointments,
sprays, patches) and dosage strengths (e.g., 50. 100, 250, 500 mg.)
The final formulation will include substances other than the active
ingredient, called excipients. Excipients
are added to improve the
taste of an oral product, to allow the active ingredient to be
compounded into stable tablets, to delay the drug's absorption into
the body, or to prevent bacterial growth in liquid or cream
preparations. The impact of each on the human body must be tested.
Toxicology and Safety Testing Tests to determine the potential
risk a compound poses to man and the environment. These studies
involve the use of animals, tissue cultures, and other test systems to
examine the relationship between factors such as dose level, frequency
of administration, and duration of exposure to both the short- and
long-term survival of living organisms. Tests provide information on
the dose-response pattern of the compound and its toxic effects. Most
toxicology and safety testing is conducted on new molecular entities
prior to their human introduction, but companies can choose to delay
long-term toxicity testing until after the therapeutic potential of
the product is established.
Regulatory Review: Investigational New Drug (IND) Application
An application filed with the U.S. Food and Drug Administration
(FDA) prior to human testing. The IND
application is a compilation of all known information about the
compound. It also includes a description of the clinical research plan
for the product and the specific protocol for phase I study. Unless
the FDA says no, the IND is automatically approved after 30 days and
clinical tests can begin.
Phase I Clinical Evaluation The first testing of a new
compound in human subjects, for the purpose of establishing the
tolerance of healthy human subjects at different doses, defining its pharmacological
effects at anticipated therapeutic levels, and studying
its absorption, distribution, metabolism, and
excretion patterns in
humans.
Phase II Clinical Evaluation Controlled clinical trials
of a compound's potential usefulness and short term risks. A
relatively small number of patients, usually no more than several
hundred subjects, enrolled in phase II studies.
Phase III Clinical Evaluation Controlled and
uncontrolled clinical trials of a drug's safety and effectiveness in
hospital and outpatient settings. Phase III studies gather precise
information on the drug's effectiveness for specific indications,
determine whether the drug produces a broader range of adverse effects
than those exhibited in the small study populations of phase I and II
studies, and identify the best way of administering and using the drug
for the purpose intended. If the drug is approved, this information
forms the basis for deciding the content of the product label. Phase
III studies can involve several hundred to several thousand subjects.
Process Development for Manufacturing and Quality Control
Engineering and manufacturing design activities to establish a
company's capacity to produce a product in large volume and
development of procedures to ensure chemical stability, batch-to-batch
uniformity, and overall product quality.
Bioavailability Studies The use of healthy volunteers to
document the rate of absorption and excretion from the body of a
compound's active ingredients. Companies conduct
bioavailability
studies both at the beginning of human testing and just prior to
marketing to show that the formulation used to demonstrate safety and
efficacy in clinical trials is equivalent to the product that will be
distributed for sale. Companies also conduct bioavailability studies
on marketed products whenever they change the method used to
administer the drug (e.g., from injection or oral dose form), the
composition of the drug, the concentration of the active ingredient,
or the manufacturing process used to produce the drug.
Regulatory Review: New Drug Application (NDA) An
application to the FDA for approval to market a new drug. All
information about the drug gathered during the drug discovery and
development process is assembled in the NDA. During the review period,
the FDA may ask the company for additional information about the
product or seek clarification of the data contained in the
application.
Post approval Research Experimental studies and
surveillance activities undertaken after a drug is approved for
marketing. Clinical trials conducted after a drug is marketed
(referred to as phase IV studies in the United States) are an
important source of information on as yet undetected adverse outcomes,
especially in populations that may not have been involved the
premarketing trials (e.g., children, the elderly, pregnant women) and
the drug's long-term morbidity and mortality profile. Regulatory
authorities can require companies to conduct Phase IV studies as a
condition of market approval. Companies often conduct post-marketing
studies in the absence of a regulatory mandate.
Drug Prices
Almost everybody has bought
medications in the pharmacy. You certainly have paid attention to
the high prices that all of us have to pay in order to by new drugs.
Sometimes you buy 10 tablets for $ 50, sometimes you pay even more.
=========================================================================
Why
do these tiny pills cost so much? Please, share your opinion:
(Please don't abuse
answering this question. You can be asked one on your future job
interview. We are reviewing all of your answers and we will contact you in order to
correct any serious mistakes.)
You may be right, that
the drug market is demand / supply regulated as any other market is.
But there is another factor that you have probably mentioned in
your statement above: the new drug development and approval process is
extremely costly and risky venture. It could cost tens and even
hundreds of millions of dollars and could yield absolutely nothing in the
end. In the frames of development of one new medication, the
pharmaceutical company screens up to 10,000 compounds, when only
200-300 of them enter pre-clinical testing, and only 5-6 start
clinical testing . In the end you can have only one making it to the
market, and even this would happen only if you are lucky enough.
This is not all. Now, you have to succeed in the marketing of your
new drug. And that's not easy with all this competition around.
Clinical Research is an important part of the process that every new
therapeutic product should pass in order to receive approval to be
placed on the pharmaceutical market. No clinical trial could be done
without you, if you chose to become CRA
(Clinical Research Associate) , of course. Now you can see why a pharmaceutical company or contract research organization would be
desperate to hire you and pay you very substantial wages in order to
ensure that this research runs smoothly with no delays. (every day of delay
can cost up to 1 million dollars in losses). It's all about money,
money - it is all about . . .
=====================================================================
What would you do, if one day you get an idea
for a new
therapeutic compound with the wonderful ability to treat all human
diseases. How would you get it to the market?
Please, share your
opinion:
(Please don't abuse
answering this question. You can be asked one on your future job
interview. We are reviewing all of your answers and we will contact you in order to
correct any serious mistakes.)
