Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

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Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction. Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

The European Federation of Pharmaceutical Industries and Associations (Efpia) said a survey of its members showed 45 percent of companies expected trade delays if Britain and Europe fell back onto World Trade Organization rules after Brexit. Drugmakers also face an additional hurdle when it comes to licensing their products, since more than 12,000 medicines will require a separate UK licence in order for them to be prescribed. “For life-saving and life-improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU,” said Efpia Director General Nathalie Moll.

Pharmaceutical companies have insisted since last year’s Brexit referendum that a comprehensive agreement is needed to ensure maximum alignment between EU and British pharmaceutical regulations. But with the clock ticking down to Brexit in March 2019 with no sign yet that a trade deal will be concluded, many companies are now starting to draw up plans to protect drug supply chains, including building extra testing centres in Europe.

 

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Lonza news Tolvaptan identified as a treatment for autosomal dominant polycystic kidney disease

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease…

Tolvaptan identified

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most common form of polycystic kidney disease, a condition with no cure.

This is the first treatment that targets a mechanism that directly contributes to the development and growth of the kidney cysts in autosomal dominant polycystic kidney disease

The results of the trial demonstrated tolvaptan’s ability to intervene in a way that slows kidney function decline in this population.

“This is the first treatment that targets a mechanism that directly contributes to the development and growth of the kidney cysts in autosomal dominant polycystic kidney disease,” says Dr Vicente Torres, director of Mayo Clinic’s Translational Polycystic Kidney Disease Center. “This in effect means it may delay the need for a kidney transplant or dialysis in patients with this disease.”

Autosomal dominant polycystic kidney disease is an inherited condition that affects 1 in every 500 to 1,000 individuals in the U.S. This disease is found in all races and sexes. Autosomal dominant polycystic kidney disease, which is the fourth most common cause of end-stage kidney disease, requires dialysis or a kidney transplant.

The disease causes a slow but relentless growth of cysts that damage the kidneys. In addition to negatively affecting the quality of life, the condition also causes hypertension and painful complications. The cysts, which can damage kidneys with their size, can develop in other organs, especially the liver.

Approximately half of individuals with autosomal dominant polycystic kidney disease eventually will require dialysis or kidney transplant by age 60.

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Video of father comforting newborn son receiving his first vaccines goes viral

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On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, he also continually reassured his son that he could cry if he needed to.

TEARS AS CONJOINED TWINS DIE DAY AFTER BIRTH

When it came time for the vaccinations, Lee held his son in his arms and told the little boy to “stay strong,” while Shamekia Harris, Lee’s girlfriend, recorded the visit on her phone. Little Debias did cry as the nurse gave him his shots, but stopped soon afterward when Lee consoled him.

The video has since gone viral, with about 13 million views, 51 thousand likes, and 186 thousand shares as of Wednesday.

Sadly, Lee’s father, Anthony Lee, 57, died that same day due to complications from drinking. Lee explained to People that he was emotional and very close to his father, and that he later spoke to his son Debias about his hopes for the future.

“I talked to him like a grown up … I told him, before I leave, want to see him succeed,” Lee said.

Lee wishes that the video will remind others of the importance of fatherhood, “I want them to take care of their kids, because when you sign up for something, you have to stick with it,” he told People.

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Lee, however, isn’t the only person to go viral for his vaccination video: In 2014, pediatrician Michael Darden gained attention for his unique approach to giving shots, and the video still doesn’t disappoint:

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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

 

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions.

Walgreens, Rite Aid and CVS Health stocks each slipped 4 percent or more as investors worried Amazon may disrupt the traditional distributors’ hold on the drug prescription market.

Amazon will decide before Thanksgiving whether to move into selling prescription drugs online, according to a source and an email from Amazon viewed by CNBC.

Amazon typically spends years researching opportunities before it telegraphs its intentions. The opportunity to sell drugs online is alluring given its market size – analysts have estimated the U.S. prescription

 

Read More: http://snip.ly/j7tf0#https://www.cnbc.com/2017/10/06/drugstore-stocks-tumble-as-amazon-considers-selling-prescription-drugs-online.html

Are any weight loss supplements considered safe?

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Every year, millions of Americans go after this same goal, some successful and others not so much. To attain their goals, they may choose from the over-abundance of diets and exercise programs available, and some turn to weight loss supplements as well.

While you shouldn’t rely on supplements to do all the work for you, there are a few that can be used safely to boost your weight loss efforts.

Before you decide on weight loss supplements, though, you should consider the health effects carefully. Always check with your doctor first to be sure about safety, and remember that these pills are supplements. They’re meant to be used alongside healthy eating habits and proper exercise.

DO YOU HAVE LIVER DAMAGE?

Again, never use supplements by themselves to lose weight. Some people turn to weight loss pills so that they can continue an unhealthy lifestyle while staying thin.

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 This dangerous mentality could lead to frightening situations like addiction, overdose or death. Also, brands that claim to shed weight without any effort may contain ingredients that will do you more harm than good. If you have any doubt about a supplement, stay away.

Weight Loss Supplements that Work

Just like any other medication, weight loss supplements have both benefits and side effects. When choosing a supplement, you should know all the possible effects and consider them in light of your own health history. Especially if you have other health issues, you should check carefully for ingredients that may trigger or worsen your symptoms.

Let’s look at 3 supplements that you could consider adding to your weight loss program:

1. Green Tea Extract

Green tea has long been known for its health benefits, mainly because the drink is high in antioxidants. In particular, green tea contains large amounts of polyphenol antioxidants called catechins, which may help reduce oxidative stress.

For weight loss, studies have shown that green tea extract can help boost the metabolism. Researchers think that the combination of antioxidants and caffeine work together to accomplish this goal.

 

Read More: http://snip.ly/1alkc#http://www.foxnews.com/health/2017/10/06/are-any-weight-loss-supplements-considered-safe.html

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

Ensuring the accuracy, reliability and consistency of analytical data in laboratories

The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.

The aim of doing so is to substantiate the suitability of intended use of a particular test. It also confirms that the quality, purity, identity and strength parameters required for a product produced in the laboratory are fulfilled in the required and set measure.

The acute need for validation of analytical data

A number of reasons can be ascribed for why analytical data has to be validated for the criteria described above:

  • The quality of the data is best indicated and assessed by validation;
  • This is a means to ensure the trustworthiness of the analytical data;
  • All these steps – validation, verification and transfer of analytical methods -are set out by regulatory the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH requirements, and are thus part of regulatory requirements.

Method validation and compendial methods

Ensuring the accuracy, reliability and consistency of analytical data in laboratories3

Lately, regulatory agencies and industry task forces have been taking a more than cursory interest in method validation. The FDA, as well as the EMA, have recently come up with guidelines on method validation and transfer. Also, USP has proposed new chapters for approaches to the following important areas:

  • Integrated validation
  • Verification and transfer of analytical procedures
  • Equivalency testing and for statistical evaluation.

Compendial methods

That compendial methods are verified needs to be demonstrated in two aspects:

  • The suitability of laboratories to successfully run the method, and
  • To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Complete learning on validation, verification and transfer of analytical methods

Ensuring the accuracy, reliability and consistency of analytical data in laboratories1

All the issues relating to validation, verification and transfer of analytical methods will be taught during a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director at this seminar.

Interested in gaining complete knowledge of all areas relating to validation, verification and transfer of analytical methods? Then, please register for this seminar by visiting Ensuring the accuracy, reliability and consistency of analytical data in laboratories.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Meaningful learning over two days

Ensuring the accuracy, reliability and consistency of analytical data in laboratories4

Dr. Huber will familiarize participants of this event with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. The strategies needed for this, which he will explain, will constitute an even more significant learning.

The Director of this seminar will provide tools to implement most critical requirements, along with templates and examples for developing inspection-ready documentation. At this highly interactive seminar, Dr. Huber will augment the workshop with exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

Participants will also be offered a variety of tools that the Director of this seminar will offer them, such as SOPs, validation examples and checklists. All of these will be made readily available on a dedicated website, and can be used to easily implement the learning gained in the course.