Drug dissolution testing and establishing plasma drug levels in humans

Drug dissolution testing and establishing plasma drug levels in humans5

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

Drug dissolution testing and establishing plasma drug levels in humans

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

Drug dissolution testing and establishing plasma drug levels in humans1

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

A step towards better health care

 

step towardsToday, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example is a practice known as “step therapy” or “fail first.”

Now, when patients visit their doctors for a prescription, the treatments they are prescribed are typically based on a variety of personal factors. These factors include their health history, underlying symptoms, and their doctor’s long-term understanding of their condition, such as whether they have already tried certain drugs under a different health insurance plan, if they have other medical conditions that might interfere with the drug’s effect, whether certain drug’s side effects will affect the patient’s ability to perform their job, or if the patient would prefer a drug that has a different ingestion method or dosage form. Treatment plans need to be based on the individual’s needs, and their doctors’ medical expertise and first-hand knowledge of their patients’ overall health.

 However, far too often, what happens next is the problem. When a patient goes to the pharmacy to fill their prescription, they may be informed that their physician-prescribed medicine will not be covered unless the patient first proves that another medication-one of the insurer’s choosing, not their doctor-will not work for them.

In such a case as this, failure is not only an option, it is the only option before getting appropriate treatment.

Under the current system, patients are left with a limited set of options: either try a medication that is not what their doctor recommended for their condition, or pay out of pocket for the treatment they need. For many people, that’s not a choice at all. They are simply forced to fail on a medication other than what their doctor prescribed.

Read More: http://snip.ly/3h8ax#http://thehill.com/blogs/congress-blog/healthcare/356083-a-step-towards-better-health-care

Flu vaccine: NHS patients wanted to test ‘universal’ jab

Flu vaccine NHS pa

Researchers are seeking about 500 NHS patients to try out a new “universal” vaccine against seasonal flu.

The experimental vaccine works differently from the one currently available, which has to be remade each year based on a “best guess” of what type of flu is likely to be about.

The new jab targets part of the virus that does not change each year.

This means the vaccine should work against human, bird and swine flu, say the team at University of Oxford.

It will offer people better protection, they believe.

Extra protection

Immunisation is the best defence we have against flu but it is not always effective.

Last winter’s vaccine cut the risk of flu in adults under the age of 65 by about 40%, but barely worked in people over 65, despite being a good match for the type of flu in circulation.

As people age, their immune systems are often weaker and their bodies may not respond as well to a vaccine as younger people’s bodies.

Prof Sarah Gilbert and colleagues believe that using their vaccine alongside the current one could help.

It is the world’s first widespread human testing of such a vaccine, according to the National Institute for Health Research, which is supporting the project.

 

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Patients aged 65 or older and living in Berkshire and Oxfordshire will be invited to take part in the trial.

Half of the 500 volunteers will receive the usual seasonal flu jab and a placebo or dummy jab, while the other half with get the regular vaccine plus the new experimental one.

Read More: http://snip.ly/dqyht#http://www.bbc.com/news/health-41467097

Program for parents improves ADHD behaviors in young children

Program for parents improves ADHD beha

A program that focuses on strengthening parenting skills also improves symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in 3-8 year-olds, according to researchers at the at the University of North Carolina at Chapel Hill. FPG scientists completed a rigorous review of evidence that demonstrated the effectiveness of the “Incredible Years Basic Parent Program.”

“Prior research already has shown that this program improves behavior difficulties in young ,” said Desiree W. Murray, FPG’s associate director of research. “This review provides new evidence specifically about its effectiveness for ADHD symptoms.”

Murray explained that not only reported sustained improvements for their children’s ADHD behaviors, but also for their social skills and interactions with peers.

She said effective early intervention is crucial for young children with ADHD, due to the unfavorable short-term and long-term outcomes associated with the disorder.

“ADHD in preschoolers can bring conflict with family members, and it carries elevated risk of physical injuries and suspension or expulsion from child care settings,” Murray said. “Negative trajectories over time can include the development of other psychiatric disorders and difficulties with social adjustment.”

Previous studies have also shown that children with ADHD struggle academically, with lower test scores and higher risk of dropping out of high school.

“We can help to prevent the wide array of negative outcomes that are associated with ADHD,” Murray said. “We believe the most effective intervention approaches may be those that target preschoolers with symptoms of ADHD but who have not yet met the full criteria for diagnosis with ADHD.”

Murray and her team, which included FPG research scientist Doré R. LaForett and UNC doctoral student Jacqueline R. Lawrence, screened 258 studies and narrowed their list to 11 studies that met stringent criteria for rigor and methodology. The evidence—primarily parent reports—showed the effectiveness of the Incredible Years Basic Parent Program for ADHD behaviors in young children. The Journal of Emotional and Behavioral Disorders recently published the results of the team’s review.

The Incredible Years Basic Parent Program is designed for parents of high-risk children and those who display behavioral problems. It focuses on helping parents strengthen relationships with their children, providing praise and incentives, setting limits, establishing ground rules, and effectively addressing misbehavior.

Read More: http://snip.ly/kj65u#https://medicalxpress.com/news/2017-10-parents-adhd-behaviors-young-children.html

 

FDA approves first commercial product for peanut allergy prevention

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The approach towards preventing peanut allergies has changed dramatically in recent years. Now the US Food and Drug Administration has approved the first commercial product, called Hello, Peanut!, to help inform the public that early peanut introduction and regular consumption can reduce the risk of peanut allergy in young children.

The Hello, Peanut! introduction kit offers convenience in the form of packets of peanut powder blended with oat given in increasing quantities for seven days, as long as children tolerate it well. After which maintenance packets are recommended for use up to three times a week. The introduction kit is $25, and the maintenance kit sells for $20 for eight packets.

The FDA decision was informed by the landmark Learning Early About Peanut Allergy study published in 2015. It showed that high-risk children who regularly consumed peanut in infancy had far fewer peanut allergies by age 5 than their counterparts who avoided peanut over the same span of time. This understanding led to new guidelines published in 2017 by National Institutes of Health about giving peanut to babies to protect against peanut allergy.

Infants who have severe eczema or egg allergy are considered at high-risk of developing a peanut allergy. By offering peanut early in life – between 4-6 months of age – and continuing with regular consumption, we can prevent the onset of peanut allergy in many of these children. High-risk children should see their doctor before parents introduce peanut protein in any form. The physician may decide to do skin or blood testing.  If the test is negative, age-appropriate peanut products can be given at home. However, if a child tests positive, introduction to peanut is done under clinical supervision. If the child is deemed already allergic to peanuts, the guidelines recommend strict avoidance of peanut and ready access to epinephrine auto-injectors.

Read More: http://snip.ly/ktety#http://www.philly.com/philly/health/kids-families/fda-approves-first-commercial-product-for-peanut-allergy-prevention-20170926.html

6 Ways To Start Improving Your Gut Health Today

Brooke Lark / Unsplash

Considering the rapid rise in kombucha, sauerkraut and probiotic products, it’s pretty clear gut health is on everyone’s minds. And with good reason — more and more research is emerging showing just how important good gut health is for overall wellbeing.

“Having a healthy gut is so important,” accredited practising dietitian and sports dietitian Chloe McLeod told HuffPost Australia.

“It’s linked to a number of different medical conditions. When your gut isn’t healthy it can have an impact on mental health, weight, mood and a number of other digestive disorders. Keeping your gut nice and healthy can help keep the rest of your body healthy.”

Brooke Lark / Unsplash

How do you know if you have good gut health?

“Signs of good gut health include not getting bloating, gas, diarrhoea and constipation,” McLeod said.

“You find you feel better in general — better mood, more energy, a healthy weight and not feeling fatigued. These are all more pronounced when your gut is healthier.”

How do you know if you have bad gut health?

“If you have poor gut health you may have loose, unformed stools, or you’re really constipated, maybe your faeces are foul smelling, you feel gassy, feel foggy headed or have poor mood. These are some of the most common signs,” McLeod explained.

What can negatively affect gut health?

There are a number of diet and lifestyle-related factors which can impact the health of your gut.

“From a nutrition perspective, factors that negatively impact gut health include poor diet, alcohol and having a high fat intake,” McLeod said.

“Also, if you are someone with food intolerances, any large quantity of those trigger foods can have a negative effect on your gut health.

“Being highly stressed all the time impacts cortisol levels, and stress can be a factor for some people. Some medications can also affect gut health.”

 

Read More: http://snip.ly/r70uc#http://www.huffingtonpost.com.au/2017/09/24/6-ways-to-start-improving-your-gut-health-today_a_23218661/

Depression: Is brain inflammation tied to suicidal thoughts?

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A new study confirms the link between inflammation of the brain and the prevalence of suicidal thoughts in people diagnosed with major depression. This is the first study of its kind to measure relevant biomarkers in living individuals.

Major depression is a very common mental condition, with 6.7 percent of all adults in the United States having had at least one severe depressive episode in 2014 or 2015.

According to the World Health Organization (WHO), depression is also currently the leading cause of years spent with disability worldwide.

Some people diagnosed with major depression experience suicidal thoughts, which may result in suicide attempts. In the U.S., “suicide is the 10th leading cause of death.” Now, researchers wonder whether or not suicidal ideation in people with major depression may be linked to abnormal inflammation of the brain.

Dr. Peter Talbot and other researchers based at the University of Manchester in the United Kingdom have conducted a study testing the levels of a biomarker associated with brain inflammation in the systems of people diagnosed with clinical depression.

The scientists’ findings were reported in the journal Biological Psychiatry.

 

Read More: https://www.medicalnewstoday.com/articles/319526.php?utm_campaign=sniply&utm_medium=sniply&utm_source=sniply