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

 

Analysis: Single-payer would drastically change American health care; here’s how it works

Analysis Single-payer would

As Republican efforts to repeal and replace the Affordable Care Act continue in the background, some Democrats are starting to eye a new health policy goal: implementing a single-payer system. Sen. Bernie Sanders, I-Vt., introduced a single-payer bill in mid-September with 16 Democratic co-sponsors — 16 more than he got when he introduced the bill two years earlier. But how is the health care system funded now, and how would “single-payer” change that?

How health care systems are funded

There are three major components to every health care system, single-payer or not: a patient, a payer (typically an insurance company or the government) and a provider. Here’s how money moves between them:

How multipayer systems work

Virtually all health care systems follow this general pattern, but who the payers are can vary widely. In the U.S. private insurance market, patients typically purchase coverage from one insurance company among many competing insurers. Because different people end up with different insurers, there are multiple payers throughout the U.S. health care system.

How single-payer systems work

In a purely single-payer system, there is, as the name would indicate, just one payer — typically the government. This is analogous to how the United States administers some portions of Medicaid: The government provides coverage, and no private insurers are involved.

Sanders’ bill takes universal coverage close to this extreme: The government insurance would cover so many services with such small copays that private insurance would be almost universally unnecessary. Accordingly, it would also be quite expensive — $32 trillion over 10 years, according to an Urban Institute report. That’s more than a 50 percent increase in federal spending — all federal spending — according to spending projections by the Congressional Budget Office. That would be partially offset by people no longer needing to pay premiums to private insurers, however, and the government’s monopoly could allow it to implement cost-saving measures.

Read More: http://snip.ly/mt3iy#http://www.chicagotribune.com/business/ct-biz-how-single-payer-health-care-works-20171018-story.html

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

‘Synthetic lethality’ targets cancer cells by damaging vulnerable DNA

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By designing small molecules that can “turn off” kinase enzymes stuck in the “on” position, they have managed to ward off cancer’s attack. More recently, scientists have focused on ways to help the body’s own immune cells seek and destroy cancer cells.

Enter the concept known as synthetic lethality. Researchers have long known that a cancer cell hobbling along with one broken gene is vulnerable. Knock out another key gene, they have discovered, and the cell will topple.

The notion of killing cancer cells by damaging their already compromised DNA should sound familiar. Chemotherapy agents do just that, but by using a sledgehammer to smash away at DNA. Because drugs that exploit synthetic lethality act with precision, they promise to be able to discriminate between healthy and diseased cells.

“In experiments, you have a perfectly happy cell, you remove one gene and challenge it with one stress, and it dies. You think, ‘Yeah, I’ve got a target now!’ ” says [structural biologist Lance] Pearl, whose lab is working on drugs against synthetic lethal targets. “But that’s not a tumor.”

“Right now, the field is okay at the cellular level. But finding drugs and making sure they actually work in a real tumor is where they need to go.”

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: Driving cancer beyond the brink

Breast cancer warning from man stunned by ‘impossible’ diagnosis

Breast cancer warning from man stunned by 'impossible' diagnosis.jpg

When you think of breast cancer, you think of a form of cancer that affects only women. It doesn’t.

While breast cancer in men is rare it’s still an issue for the 10 men on average who are diagnosed with it every year in Northern Ireland.

Ian Cranston, 70, was diagnosed with breast cancer in May. Two weeks later he had a mastectomy.

The Portadown father-of-two was given the all-clear in June and has decided to speak publicly to make men aware that it’s a cancer that doesn’t just affect women.

He said “men also need to check their breasts for changes”.

Inverted nipple

In May, Ian’s wife Elizabeth noticed something wrong when he got out of the shower.

Image copyright SPL
Image caption About 10 men in Northern Ireland are diagnosed with breast cancer each year

She told him he had an inverted nipple and needed to see his GP.

“I didn’t know what that meant,” said Ian.

“Men can’t get breast cancer, I don’t have to go to the doctor.

“I wasn’t aware I had breasts. This is my chest, men don’t have breasts, it’s impossible,” he added.

Eventually his wife persuaded him to go to his GP, who referred him to Craigavon Area Hospital.

Image caption Ian Cranston alongside breast care specialist nurse Annie Treanor

The diagnosis stunned him.

“Men having breast cancer, I couldn’t believe it,” he said.

“I couldn’t do or say anything. My wife Elizabeth cried.”

Four days later Ian said he “just broke”.

He has decided to help try and raise awareness of the disease, saying that if his speaking out helped one man, it would be worth it.

“I can understand where women are coming from because I’ve had breast cancer myself,” he said.

How We Need to Keep Growing Up: http://snip.ly/ljoxy#http://www.bbc.com/news/uk-northern-ireland-41616265

Collins: Trump should back effort to resume health subsidy

Collins Trump should back effort to resume health subsidy.jpg

A key moderate Republican is urging President Donald Trump to support a bipartisan Senate effort to reinstate insurer payments, calling his move to halt the subsidies an immediate threat to millions of Americans who could now face rising premiums and lost health care coverage.

“What the president is doing is affecting people’s access and the cost of health care right now,” said Sen. Susan Collins of Maine, who has cast pivotal votes on health care in the narrowly divided Senate. “This is not a bailout of the insurers. What this money is used for is to help low-income people afford their deductibles and their co-pays.”

“Congress needs to step in and I hope that the president will take a look at what we’re doing,” she added.

Her comments Sunday came amid rising attention on the bipartisan bid led by Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., to at least temporarily reinstate the payments.

Congressional Republicans are divided over the effort. And White House budget director Mick Mulvaney has suggested that Trump may oppose the agreement unless he gets something in return — such as a repeal of former President Barack Obama’s health care law or funding of Trump’s promised wall on the U.S.-Mexico border.

The insurer payments will be stopped beginning this week, with sign-up season for subsidized private insurance set to start Nov. 1.

“The president is not going to continue to throw good money after bad, give $7 billion to insurance companies unless something changes about Obamacare that would justify it,” said Sen. Lindsey Graham, R-S.C., who golfed with Trump Saturday at the Trump National Golf Club in Sterling, Virginia.

“It’s got to be a good deal,” Graham said.

In his decision last week, Trump derided the $7 billion in subsidies as bailouts to insurers and indicated he was trying to pressure Democrats into negotiating an Obamacare repeal, a bid that repeatedly crashed in the GOP-run Senate this summer.

The subsidies are designed to lower out-of-pocket costs for insurers, which are required under Obama’s law to reduce poorer people’s expenses — about 6 million people. To recoup the lost money, carriers are likely to raise 2018 premiums for people buying their own health insurance policies.

Alexander and Murray have been seeking a deal that the Tennessee Republican has said would reinstate the payments for two years. In exchange, Alexander said, Republicans want “meaningful flexibility for states” to offer lower-cost insurance policies with less coverage than Obama’s law mandates

keep enhancing Quality management system

Do You Have Questions about Disposable Dust Masks? We Have Answers!

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The two most-common questions I hear when it comes to disposable dust masks/respirators are: “My employees wear disposable dust masks – do I have to fit test these employees?” and “How often should they change out their mask for a new one?”

First, it’s important to consider the masks themselves. These devices often are referred to as filtering facepieces and can be approved or unapproved. Unapproved dust masks can be mistaken for approved products.

So how can you tell the difference? An unapproved dust mask will not have a NIOSH stamp of approval on it. An approved filtering facepiece, such as an N95/P95/N100 particulate respirator, always will have a NIOSH stamp on it. Approved respirators must be used if a fit test is performed.

Do I have to fit test employees?

Voluntary-use masks – When the contaminant exposure does not exceed the OSHA PEL (permissible exposure limit), or the employer does not require the employees to wear a respirator (despite being underexposed), either an approved or unapproved dust mask can be made available to the employee, or they can use their own. This is referred to as voluntary use. Fit testing is not required for either product if it is voluntary use.  (Refer to OSHA 29CFR1910.134 for additional information on voluntary use. For instance, the employer must provide employees with the information contained in Appendix D of OSHA 2CFR1910.134.)

Required-use masks – When the employer requires workers to wear approved dust masks to protect against contaminants, then all elements of the OSHA respiratory standard apply, including fit testing, medical evaluations, training and program evaluations. Approved protocols for fit testing are included in the standard. (Please refer to OSHA 29CFR1910.134 for details.)

When should employees get a new respirator?

When determining if employees need new respirators, remember the three D’s:

• Dirty
• Damaged
• Difficult to breathe through

Dirty respirators – A respirator cannot have dirt or debris where it contact with the face. Dirt and debris not only affect the performance of the respirator, they also can expose the user directly to contaminants, particularly if the debris is contaminated or otherwise toxic. For example: An employee works in a dusty area. He takes his mask off and leaves it in the work area for the weekend. When he comes back, the inside of the mask has been exposed to contaminants for two days. It is very likely that the first breath he takes is contaminated.

Damaged respriators – If a strap or nose clip is broken then the product cannot properly seal on the face and cannot be used. It sounds simple, but I’ve seen respirators that looked like they were 10 years old. If your mask has an exhalation valve, make sure that it is free of debris and not damaged.

Read More: http://www.ehstoday.com/respirators/do-you-have-questions-about-disposable-dust-masks-we-have-answers