21
Nov 13

Bridging Studies Provide Phenomenal Benefits – evaluation of the new chemical entities for different ethnic populations

Bridging studies were not done in the past, but as pharmaceutical companies chose to broaden their client base by taking their medications international, the need for bridging studies became apparent. There are a number of things that bridging studies can help to determine. They can verify efficacy and safety of certain compounds that are used in medications, they can ascertain the sensitivity of a drug when it is used in a new ethnic region, they can help to minimize clinical data duplication so that new therapies can be developed, and they can improve efficiency so that resources are not wasted. The studies can help in the registration process with regulatory authorities in various regions as well. Getting a drug approved for use is often hard to do, but bridging studies can help to streamline the process.

Why Bridging Studies Are So Vital

The studies are conducted so extensively, because regulatory authorities need proof that the drugs will not cause adverse effects. Foreign countries do not rely on clinical data from other countries alone. They will take the foreign clinical data, and compare it to their own bridging study results to see if any questions arise about the effectiveness of the drug or the side effects that come along with using is. One of the reasons why this testing is so critical, is because the adverse effects often aren’t seen in the early stages of clinical trials, so more in-depth studies are needed to test the effects of the drug long-term.

The Importance of Testing in Multiple Ethnic Groups

It is essential that clinical study results are consistent across all ethnic regions. If there is a discrepancy in even the smallest detail, then questions will need to be answered about why the results are different. Just because a drug has been tested in one region, and has been found to be safe, that doesn’t mean that the drug is actually safe for everyone to use. Not all ethnic groups have the same biological characteristics, so the drug could cause negative effects in certain groups. Part of the reason why bridging studies are conducted is to avoid this scenario. Drug manufacturers need the data, so that they can determine how to make the drug safe for everyone, no matter what region of the world that they are from. The goal is to have similar results across all ethic regions, so that researchers can ascertain whether or not the difference in effects is down to ethnicity or not.

Global Bridging Studies Provider

Looking for a Global provider of Bridging Studies that has an extensive amount of experience, and a protocol in place that will allow their scientific experts to produce accurate results with the readings that the studies give. For more information please visit http://www.richmondpharmacology.com/bridging-studies.php


10
May 13

Why are early phase studies and clinical trials important?

A tool that the pharmaceutical companies, use to research the potential of new medicines is through early phase studies of new drugs, which are also known as clinical trials. These trials are conducted under clinical conditions, in order for the data to be analysed so the product can be stamped as safe and then is put on the market.

What is an Early Phase Study: Wikipedia reveals all facts related to a clinical trial >

For an early phase clinical study to take place, volunteers are needed from every sort of background and they can either volunteer or be compensated. However, there have been questions whether or not these clinical trials are safe or not. Normally, a product is not used in a trial unless it has gone through extensive, careful and laboratory research before it is thought to be safe to test on human volunteers.

Transporting a new drug into the market successfully depends almost solely on the facts of the safety and the effectiveness of the drugs by conducting early phase clinical trials. A trial, normally, will include healthy volunteers, however, sometimes will have a pilot study with patients that could take advantage of the tested product.

Conducting a study can be costly and the finical responsibility is carried shouldered by the sponsor, who maybe a branch of government, a biotechnology or a pharmaceutical company. Since trials can be large and diverse, companies often give the control to a partner that is outsourced like an early phase studies provider.

Usually referred to as a clinical research organization, these early phase study service providers commonly work for the pharmaceutical industries, which is concerned with the developing process of a new drug, but may conduct tests on drugs that are already developed.


11
Apr 13

Choosing a Repeat Caesarean?

Some women would rather plan a repeat caesarean, than face the worry that an attempt at vaginal birth would end in caesarean anyway. Your chances of a successful vaginal birth vary according to various factors, such as the reasons for your past caesarean, and the number of past caesareans you have had. These and other [...]


11
Apr 13

Why do people worry about VBAC?

Uterine Rupture A mother who has had a past caesarean is at higher risk of uterine rupture than a mother whose uterus has not been operated on. This means that the old caesarean scar might not stand the strain of labour, and could tear open. The risk of this happening with a standard, modern caesarean [...]


11
Apr 13

In what ways is home VBAC less safe than hospital?

Monitoring the baby Continuous electronic fetal monitoring is not usually available at home. Instead, the midwife or doctor can monitor the baby by listening to its heart with a Sonicaid or stethoscope, and she can monitor the mother by watching her carefully, and taking her pulse and blood pressure. One of the first signs of [...]


11
May 11

Is home birth after caesarean an option?

Some mothers believe that the way to give themselves, and their babies, the best chance of a good and safe VBAC (vaginal birth after caesarean) is to plan a home birth. Home birth need not be dismissed as an option because a woman has had a previous caesarean birth, but it does need careful consideration. [...]


11
May 11

Vaginal Birth After Caesarean?

Women who have had a previous caesarean birth are a higher-risk group for future vaginal births. VBAC is the usual term for Vaginal Birth After Caesarean, and is pronounced ‘Vee-back’. These pages were initially written after requests from women considering home VBAC, but they are also relevant for those planning hospital births. Why consider VBAC? [...]