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21 cfr part 11 definitions terms used for clinical trials

2010-12-11T09:18:00.000-08:00

Definitions and Terms for clinical trail electronic records regulations
21 cfr part 11 definitions terms used for clinical trials
Audit Trail: an audit trail is a process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the course of such details relating to the electronic record.
Certified Copy: A certified copy is a copy of original information that has been verified, as
indicated by a dated signature, as an exact copy having all of the same attributes and information
as the original.
area classification for clean rooms
Computerized System: A computerized system includes computer hardware, software, and
associated documents (e.g., user manual) that create, modify, maintain, archive, retrieve, or
transmit in digital form information related to the conduct of a clinical trial.
Direct Entry: Direct entry is recording data where an electronic record is the original means of
capturing the data. Examples are the keying by an individual of original observations into a
system, or automatic recording by the system of the output of a balance that measures subject’s
body weight.
FDA guidelines
Original data: For the purpose of this guidance, original data are those values that represent the
first recording of study data. FDA is allows original documents and the original data recorded
on those documents to be replaced by copies provided the copies are identical and have been
verified as such.
GMP guidelines
Source Documents: Original documents and records including, but not limited to, hospital
records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation
checklists, pharmacy dispensing records, recorded data from automated instruments, copies or
transcriptions certified after verification as being accurate and complete, microfiches,
photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at
the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical
trial.
Pharmaceutical Companies
Transmit: Transmit is to transfer data within or among clinical study sites, contract research organizations, data management centers, sponsors, or to FDA.

21 cfr part 11 definitons of terms used

2010-12-11T09:15:00.000-08:00

21 cfr part 11 definitons of terms used
Biometrics:
A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions where those features and/or actions are both unique to that individual and measurable.
FDA guidelines
Closed System:
An environment in which system access is controlled by persons who are responsible for the content of electronic records those are on the system

Computer Systems:
Validation Confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.
gmp guidelines
Digital Signature:
An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

Electronic Record:
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Electronic Signature :
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

Handwritten Signature:

The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. Off-the-Shelf Software

(OTS software):
A generally available software component for which the user can not claim complete software life cycle control

Open System:
An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.
area classification for clean rooms
Regression Analysis And Testing
A software verification and validation task to determine the extent of verification and
validation analysis and testing that must be repeated when changes are made to any
previously examined software products
Pharmaceutical Companies

Whoguideline.blogspot.com: Paramount among Pharmaceutical Manufacturing Guides

2010-10-14T02:46:00.000-07:00

Whoguideline.blogspot.com: Paramount among Pharmaceutical Manufacturing Guides

The pharmaceutical industry in the world is among the most astronomical systemized sectors. With a vast number of pharmaceutical companies, pharmacy colleges, and pharmacy students, the industry plays a vital part in endorsing and supporting development in the aspect of global medicine. The industry with its remarkable features has scaled new heights in the areas of research, development, manufacturing, and production. The technological proficiency and manpower involved in these pharmaceutical companies has resulted in its growth on a global level.

Every industry has vast in-depth knowledge about its working, manufacturing, and the regulatory affairs and conditions, on which it is based. Similarly to expertise in the pharmaceutical field, one should be well versed with all its related information regarding its manufacturing, research, development, and regulation. All this valuable and credential information can rendered to the people online through pharmaceutical blogs. Among those on internet, whoguideline.blogspot.com carves a niche in the market with a number of near about 2010 readers subscribed in a small duration. This zone of blogs covers almost each and every aspect of the pharmaceutical discipline. Except from the above mentioned areas, this website even focuses on providing the readers with the reviews on the latest developments, scientific analysis, and news in the pharma industry occurring globally. The website contains all the necessary information on Current Good Manufacturing Practices Pharmaceutical, pharmaceuticals manufacturing, GMP Guidelines, CGMP practices, and Quality assurance and regulatory affairs for pharmaceuticals adapted across the world.

The website can be considered as a vast sea of accurate knowledge in the field of drugs and pharmaceuticals. The articles submitted on the website are written by the highly rated authors, which include world-class pharmacists and pharma professionals. Being the best and latest, many of the articles are even included in the popular pharmaceuticals and medicine journals all over the world. Furthermore, the articles are even studied in institutions dealing in manufacture, development, and research in pharmaceuticals across the world. The current topics highlighted on the website are GMP documentation, CGMP requirements for pharmaceutical formulations, Quality Assurance guidelines, Good manufacturing practices, guidelines for SOP’s for microbiology department in pharmaceuticals, and Pharmaceutical Validations.
Whoguideline.blogspot.com proves to be guide not only pharmaceutical companies, but even for pharmacists and pharmacy students. The students can train themselves in pharmaceuticals CGMP practice and procedures by reading articles over the website. Being a multi-user and multi-beneficial website, it provides the grounds for the pharmaceutical professionals and students worldwide to share their views and thoughts. The blog relishes readership from the top and reputed pharma professionals belonging to elite pharmaceutical companies worldwide. With the day to day increase in the number of readers, now it is one of the most read and referred pharmaceutical information blog word wide.

garlic as a cholesterol lowing agent

2010-05-08T10:31:00.000-07:00

A clinical trial conducted to ascertain the effect of study from Stanford University casts doubt on garlic as a cholesterol lowing agent did not yield satisfactiry results garlic could not lower LDL (low density lipoprotein) cholesterol levels in adults individuals with moderately high cholesterol. LDL cholesterol is widely known as "bad cholesterol," and is believed to be a leading contributor to heart disease.
Dr.Christopher Gardner, Ph.D., and his colleagues conducted a randomized, and placebo-controlled clinical trial to study whether three different formulations of garlic could lower LDL cholesterol. In this clinical trial participants were randomly divided into four groups to receive raw garlic, a powdered garlic supplement, an aged extract supplement, or a placebo.
The 169 participants who completed the study had their cholesterol levels checked monthly for the duration of the 6-month trial. None of the formulations of garlic had a statistically significant effect on the LDL cholesterol levels.
Pharmaceutical Jobs
The authors caution that these results should not be generalized for all populations or all health effects. An accompanying editorial in the journal Archives of Internal Medicine points out that LDL cholesterol levels are only one factor contributing to heart disease, and that this trial did not investigate garlic's effects on other risk factors, such as high blood pressure.

clinical trials

2010-03-19T10:14:00.000-07:00

Clinical trials are an important part of medical research. They help scientists find better ways to prevent realize that and treatment of diseases and ailments. This brochure is an introduction to clinical trials in general Clinical trials are studies that tested the safety and efficacy of treatments and therapies People. Clinical trials are essential to the working procedures that do not comply, and to determine why. There are clinical trials in healthy people (for example, to prevent disease) and to test various and stage of disease and condition.

Participation in clinical trials can the benefits and risks "have required the federal government that the participants government-funded clinical trials are protected and carefully monitored. All known risks should be allocated Participants before they enrolled in the study.

If you are in participating in clinical trials, talk to your doctor interest. Also make sure that you understand the information contained in the consent form, had all the answers to their questions and discussed the decision with family, friends or other people whom you trust.

Review of clinical trials
Clinical trial is a study in which treatment or therapy is tested in patients to see whether they are safe and effective. Clinical trials help researchers learn what the procedures are more effective than others.

Information from clinical trials will help to improve health care and promotes understanding Diseases and Conditions (as the disease progresses and how it works) on various body systems.Clinical trials are also medical research, research, and clinical research. Each trial follows a protocol Who has a detailed plan that explains why research is necessary that they intend to do, and how they

performed. Minutes written by the chief investigator of the study, the study responsible person .

Types of clinical trials
Clinical trials are used to study many aspects of health:

Statements tests test for the treatment of a particular disease or condition.
Preventive testing started, ways to reduce the likelihood that people who are healthy, but may be at risk of disease, will develop the disease.
Early detection and screening tests to check to find new ways to diseases or conditions before they sign or produce

Symptoms.
Diagnostic tests to identify the testing of new ways to more accurately and earlier, if people have the disease and

Terms.
Supporting studies of care, quality of life studies as well as to explore ways of dealing with patients more convenience and

Them a better quality of life.
There is a widespread misconception that clinical trials are the last refuge for these illnesses tried all other treatment options. However, there is a test for healthy people (eg, studying disease Prevention) and for all the different types and stages of the disease.

Clinical studies of the phase
Since clinical trials of treatment in the testing of humans, it begins to be some clinical trial data

That the therapy can work. This data can either come in earlier laboratory studies and studies
Reports on the use of the therapy people.

Clinical studies done in several steps. In Phase I trials, researchers tested the treatment in a small group of people, Focus on safety, side effects, and sometimes the dosage and administration schedule. In phase II trials, Treatment offers a large number of people to the potential benefits and further evaluation determine its

Safety and side effects. This phase may take several years. In the test phase III, the treatment usually provided Several hundred or more people to confirm their effectiveness and to better determine any adverse effects. Phase III trials

often to be treated in accordance with the standard study compared the treatment.

At each stage, responded to several questions:

Phase I: What is a safe dose is it? What is the treatment affects the human body? What treatment should give
Phase II: If the treatment does not cause any side effects? Valid side effects? There are indications that

Therapy in the treatment of illness or useful
Phase III: How to heal better than the same or even worse than placebo or a standard (and accepted)

Treatment or approach? (See explanation on placebo.)

Common elements of clinical trials
Testing can be randomized. In a randomized study, each participant will be allocated on a random basis, or on the computer

Table of random numbers, the two treatment groups or control group. Randomization is used in all

Phase III studies and several Phase II trials. This helps to ensure that the results of the study by

Available treatment and not on factors that could cause the results and the interpretation of results in context.

Each participant has assigned an equal opportunity to a group. Some are slightly more complex tests

Groups.

The trials are often double-blind. This means that neither the researchers nor the participants knew who was

The group assigned. Blindness is another way to minimize the likelihood of bias influencing the study

Results. Information stored in the control room immediately, so the research team was appointed to find out

active treatment when they need to know.

The researchers design clinical trials to have one or more endpoints. The endpoint is a measure that defines

whether the treatment under study is important. Example is the end, whether the person

improved in the following acupuncture treatment.

Placebo
Inactive placebo treatment, treatment should look like after study. An example of the placebo --

Pill containing sugar instead of the studied drug. The fact that one group a placebo and Another group of active treatment, the researchers can compare the responses of the two groups. This gives Researchers true picture of the effects of the active treatment.

Another type of placebo group, known as "Sham", used in treatment studies is the procedure (eg Acupuncture), but not by drugs or other substances. Sham-procedure is used to simulate the active treatment, but any active treatment qualities. For example, in a clinical study of acupuncture, a sham procedure

may result from the placement of acupuncture needles in parts of the body that have no therapeutic Answer.

Placebo necessary because many other factors, the additional treatment study can affect either Course of the disease or the patient's response to treatment. For example, many symptoms of the disease or Address may affect their own, and interaction with the provider or the patient's expectations about the treatment

Patient's response. These and other factors are part of the so-called "placebo effect", the researchers tried the effects of treatment, the separate study they were obtained. Each clinical trial is in its selection criteria, ie rules that can be included, unique. Objective criteria is the identification of relevant stakeholders, to what is currently being studied and the researchers hope to

Answer. Examples of criteria are the nature and severity of illness, presence of other diseases, as well as the history of the previously

Treatment.

To the extent possible, clinical trials, people of different ages and ethnic groups and both sexes, so that The results can be applied to the population as a whole. Sometimes this is due to the fact that study, it is useful to

Trial limited to a particular group, such as women and the elderly.

Criteria are used, the process as safe as possible for the participants. For example, it can not safe for people with a serious illness to participate if they have on their regular medication

do. Criteria are not used to anyone for reasons that exclude independent of the research itself. Safety tips for students
The federal government requires a lot of protection for people participating in government-sponsored clinical trials.
pharmaceutical manufacturing
Before clinical trials can begin, you must provide a written protocol approved and supervised by the Institutional Review (IRB)-an independent group of doctors, other professionals and people from the community, the

Make sure that the study found, leading to safe and fair. IRBs also review and approve the consent Documents should be to participate to a clinical study. IRB can stop when clinical trials

The scientist was not a protocol, or if the study appears to cause unexpected harm to participants. IRB can also stop trials if the evidence is that the new intervention is effective, so that it can be

were widely as soon as possible. At the clinical trials, additional data and safety monitoring. Some clinical trials, especially Phase III -- clinical trials, often many agencies of the data in support of the Safety Monitoring Board (DSMB). DSMB is independent body, consisting of statistics, doctors and patient advocates (most of which

Non-clinical studies), the regular data from the trial risks Participation is as small as possible. Their priority is the safety of patients, they can stop the process if there are security problems or if the purpose of the study have been achieved.

Participants are also protected by a process called informed consent. People who participate in the audit are clinical trials of a session, a member of the Working Group, which provides important information on topics such as before: pharmaceutical Industry

Who in the organization and conduct of research Who reviewed and approved the study
What the scientists want to know, As a research group of the participants' health and safety monitoring What the participants will be asked during the process to be done and how long Potential benefits and risks
Other treatments that are available for a disease or condition available
As the confidentiality of pharmaceutical validation records of the participants are protected.
Informed consent When you speak with a member of the research team, while the informed consent, you have the right to all your questions answered. If you do not understand something, you get answers, ask again. This can be useful a list of questions and concerns before you speak to the study group.

The staff will also give you a consent form that explained the study and written, should be a simple

Language. Consent forms can be lengthy, and they contain a lot of information that must be carefully examined. It Good idea to take home a consent form so that you think about it and review it with family members or may

Friends. If you are interested in the study, it is also very useful to discuss this with your primary health care Manufacturer. By signing the form, you consent to participate in the proceeding. However, participation

In clinical trials is completely voluntary. You may leave the court at any time and for any reason after signed a consent form.

What happens during the study that happens depends on the nature of the samples and the study protocol. However, some activities are all equal

Studies:
The study group will examine the health of the participants at the beginning of the study, give specific instructions on Participate and monitor their health carefully during the study.
Participants may be required to carry out certain tasks between sessions, such as after the ingestion of pharmaceutical Schedule, the completion of the protocols and respond to the questionnaire.
Clinical trials are in different situations, depending on the sample, and the fact that we study instead. For example, participants can participate in a study of a system to follow the protocol at home, while the court proceedings at which specialized equipment) can (for example, acupuncture performed in a clinic or other health settings. Other Tests may be by the participants in the hospital, clinic or research center during this therapy.

What happens after the clinical trials
The researchers carefully analyze data from the study, and then consider, take into account their findings. If the court completed and the results of medical significance, the researchers share their findings with the Medical profession and the public. The results are usually reported in peer-reviewed medical journals,

( "Peer review" means that the report dealt with before the publication of a group of experts in the same area) and / or scientific conferences discussed. The media can also provide the results of this study. The Study Group also completed informed the participants about research results shortly after the study, and all of their data analyzed. The participants should focus on the study group, if they know the expected results.

The treatment was the safe and effective in carefully conducted clinical examination may lead to a new common practice.

If you think about participating in clinical trials:
Potential benefits and risks and Benefits
You have the opportunity to receive expert medical care and your health will be carefully monitored throughout

Research.
Clinical trials have provided excellent opportunities for the treatment or prevention of a disease or condition.
In some types of tests are among the first of the new treatment or new knowledge about the benefits --

current treatment.
You will be helping others, by the medical and scientific knowledge.

Risks
The treatment under study does not always turn out even better than, or worse, the standard therapy.

The researchers hope that it is, but they need to do this study in order to know for sure. pharmaceutical manufacturing
The treatment can have negative effects, the researchers, or otherwise than they expect are not known.
If you're in a randomized trial, you may be assigned to a different treatment than what you hope to receive. You As a rule, do not know that the group in which you
Treatment in this study can not be them.
Participation may require further tests or treatment or as regular maintenance visits.
It may cost implications, and these costs can not be covered by all insurance companies. Must Conversation with a Working Group on the possible costs

How Vaccines Prevent Disease

2009-10-22T09:25:00.000-07:00

Parents are constantly concerned about the health and safety of their children and they take many steps to protect them. These preventive measures range from child-proof door latches to child safety seats. In the same respect, vaccines work to safeguard children from illnesses and death caused by infectious diseases. Vaccines protect children by helping prepare their bodies to fight often serious, and potentially, deadly diseases.

Pharmaceutical regulatory affairs

Disease Prevention--Protect Those Around You

Disease prevention is the key to public health. It is always better to prevent a disease than to treat it. Vaccines prevent disease in the people who receive them and protect those who come into contact with unvaccinated individuals. Vaccines help prevent infectious diseases and save lives. Vaccines are responsible for the control of many infectious diseases that were once common in this country, including polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), mumps, tetanus, and Haemophilus influenzae type b (Hib).

Vaccine-preventable diseases have a costly impact, resulting in doctor's visits, hospitalizations, and premature deaths. Sick children can also cause parents to lose time from work.

Pharma companies

Each child is born with a full immune system composed of cells, glands, organs, and fluids that are located throughout his or her body to fight invading bacteria and viruses. The immune system recognizes germs that enter the body as "foreign" invaders, or antigens, and produces protein substances called antibodies to fight them. A normal, healthy immune system has the ability to produce millions of these antibodies to defend against thousands of attacks every day, doing it so naturally that people are not even aware they are being attacked and defended so often (Whitney, 1990). Many antibodies disappear once they have destroyed the invading antigens, but the cells involved in antibody production remain and become "memory cells." Memory cells remember the original antigen and then defend against it when the antigen attempts to re-infect a person, even after many decades. This protection is called immunity.

Vaccines contain the same antigens or parts of antigens that cause diseases, but the antigens in vaccines are either killed or greatly weakened. When they are injected into fatty tissue or muscle, vaccine antigens are not strong enough to produce the symptoms and signs of the disease but are strong enough for the immune system to produce antibodies against them (Tortora and Anagnostakos, 1981). The memory cells that remain prevent re-infection when they encounter that disease in the future. Thus, through vaccination, children develop immunity without suffering from the actual diseases that vaccines prevent.

Regulatory Affairs in pharmaceuticals

Why are Childhood Vaccines So Important?

It’s true that newborn babies are immune to many diseases because they have antibodies they got from their mothers. However, the duration of this immunity may last only a month to about a year. Further, young children do not have maternal immunity against some vaccine-preventable diseases, such as whooping cough.
If a child is not vaccinated and is exposed to a disease germ, the child’s body may not be strong enough to fight the disease. Before vaccines, many children died from diseases that vaccines now prevent, such as whooping cough, measles, and polio. Those same germs exist today, but babies are now protected by vaccines, so we do not see these diseases as often. FDA guidelines
Immunizing individual children also helps to protect the health of our community, especially those people who are not immunized. People who are not immunized include those who are too young to be vaccinated (e.g., children less than a year old cannot receive the measles vaccine but can be infected by the measles virus), those who cannot be vaccinated for medical reasons (e.g., children with leukemia), and those who cannot make an adequate response to vaccination. Also protected, therefore, are people who received a vaccine, but who have not developed immunity. In addition, people who are sick will be less likely to be exposed to disease germs that can be passed around by unvaccinated children. Immunization also slows down or stops disease outbreaks.

GMP guidelines

Guide for pharmacists and pharmacy student

2009-08-30T04:25:00.000-07:00

Dear friends , i am associated with pharmaceutical manufacturing , and i am a pharmacist.
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Here is this website i refeing to you as a pharmaceuticals guide

Guide for carring out internal audit of your pharmaceutical manufacturing unit , prior to FDA inspection | A complete cheke list of what to comply

2009-01-17T08:06:00.000-08:00

Guide for caring out internal audit of your pharmaceutical manufacturing unit , prior to FDA inspection | A complete check list of what to comply

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2009-01-04T00:34:00.000-08:00

WHO GMP GUIDE WHOGMP WHO-GMP FOR PHARMACEUTICALS GOOD MANUFACTURING PRACTICES GUIDE cGMP GUIDE

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WHO GMP GUIDE | WHOGMP |WHO-GMP FOR PHARMACEUTICALS |GOOD MANUFACTURING PRACTICES GUIDE cGMP GUIDE

2008-11-25T07:06:00.000-08:00

WHO GMP GUIDE | WHOGMP |WHO-GMP FOR PHARMACEUTICALS |GOOD MANUFACTURING PRACTICES GUIDE cGMP GUIDE

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2008-11-17T07:20:00.000-08:00

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2008-11-16T02:01:00.000-08:00

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2008-11-16T01:11:00.000-08:00

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WHO GMP GUIDE FOR PHARMACEUTICAL MANUFACTURERS AND FORMULATIONS

2008-09-21T07:11:00.000-07:00

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CALL FOR ABSTRACTSWe are accepting abstracts for CROI 2009

2008-09-18T00:19:00.000-07:00

CALL FOR ABSTRACTSWe are accepting abstracts for CROI 2009 which will take place at thePalais des Congres de Montreal, Montreal, Canada from February 8-11,2009. The deadline for abstract submission is Wednesday, October 1 at5:30 pm EDT. Please visit the conference web site,www.retroconference .org, for the submission instructions and subjectcategories.The Scientific Program Committee will provide a large number of younginvestigator awards for fellows and graduate students who arepresenting their work at the conference. The deadline for younginvestigator award recommendations is Monday, October 13. Informationon this program is available on line (see Awards and Scholarships) .We hope you will submit an abstract for inclusion in what promises tobe an excellent meeting in Montreal. Thank you.CROI Secretariat115 South Saint Asaph Street, Alexandria, VA 22314 USAtelephone: 703-535-6862 fax: 703-535-6899email: info@retroconferenc e.org website: www.retroconference .org____________ _______Anil PurohitHarvard Institutes of MedicineBostonE-MAIL: apurohit@bidmc. harvard.edu