Category: Health Gov

The Eight-Points Model of Analytical Development

The U.S. FDA current Good Manufacturing Procedures for drugs (CGMP, Title 21 of the Code of Federal Regulations, Parts 210 and 211) states that all pharmaceutical products must be analyzed for “identity, strength, quality, and purity.”

Many analytical development scientists in biotechnology consider these precepts too vague to serve as effective guidelines for biopharmaceutical analysis. When one of the authors (TJP) was working in the biopharmaceutical industry, he developed the following “eight points” model to guide analytical development for any new macromolecule he and his staff encountered.

Several successful regulatory filings attest to the adequacy of the model.

According to the model, assays should be developed and validated to address each of the following points:

CE can be used directly for all the points except, perhaps, numbers 4 and 8, which are usually addressed using biological and microbiological assays (supplemental CE activity assays may, however, sometimes be validated against biological assays).

Use of Capillary Electrophoresis to Assess the Identity of Proteins and Peptides

The purpose of an identity assay is to provide scientific proof that the contents of a container correspond, qualitatively, to what is claimed on that container’s label. Until the identity is established, all other analytical concerns are secondary. Because of this central role, proof of identity is usually approached by a summation of evidence from several assays. In addition, using multiple structural determination methods ensures that products are thoroughly characterized as well as adequately identified. For proteins, commonly used identity assays include specific activity, amino acid composition and sequence, and assessment of such physicochemical parameters as molecular weight and isoelectric point.

A list of assays commonly used to establish the identity of a biopharmaceutical protein is mentioned below.

o Immunoblots

o ELISAs

o RIAs

There are several CE techniques that readily lend themselves to providing evidence of a protein’s identity. These include:…

Small Diet Changes for Bodybuilding

When you begin bodybuilding that means altering your diet, but it doesn’t necessarily have to be a complete renovation that’s going to leave you hungry and unsatisfied with no sweet things or fat and if your smart it really needn’t be a big challenge. For instance, there are some easy incidental ways you can cut your fat intake and change your sweet tooth so that you begin craving healthier foods at the same time. For example, teach yourself to drink tea without sugar and to eat toast without butter. You should also cut out drinking soft drinks in favour of fruit drinks and water and remove the extra oil from your cooking; if you stir regularly and cook onions first it won’t stick, even just a bit of water will do or if you must then use vegetable oil. You can also use healthy snacks to satisfy your cravings, so that instead of eating crisps or chocolates you’re eating nuts, sunflower seeds or raisins (nuts being a protein source and the latter of which supplying a steady flow of carbs).
So far so good, but there are further complications to eating the protein that you need to understand when bodybuilding and this is the other way you need to change your diet. One complication is just how hard it is to consume the required amount of protein; a boiled egg only contains about six grams of protein, so say you’re 180 pounds that would mean you’d have to eat around 30 eggs. 300 grams of tuna – that’s a full can – contains 23.5 grams of protein. So that would be eight cans of tuna minimum and not all of that protein would be absorbed by the body. So in a real day you’d probably have to eat something like three eggs, a can of tuna, a large chicken and several protein shakes.…

What Is Sports Nourishment?

A recent college graduate was in our office the other day visiting his Mom. I asked him what was next for him now that he had his Bachelors Degree. His response was: “I think I will go for my Masters in Sports Nourishment”. I had absolutely no idea what that is, so I set out to learn.
Basically, I learned that Sports Nourishment mixes the fields of nutrition and exercise science.
While the concentration on most eating patterns is to reduce intake of calories and frequently to limit the consumption of carbs, it is obvious that sports nutrition is a little different.
Professional, and competitive athletes employ a large quantity of calories to fuel their bodies. Carbs are the body’s ideal choice for fuel and this fuel is stockpiled in the muscles as glycogen. Proteins are wanted to help reconstruct and repair damaged cells of the body.
Wikipedia tells me’ Glycogen functions as the secondary long-term energy storage in animal cells and forms an energy reserve that can be quickly mobilized to meet a sudden need for glucose, but one that is less compact than the energy reserves of triglycerides (lipids).’
Everyone understands that getting their nutrition right will make a significant difference to the way an athlete performs.
Okay, I can figure that out.
How about the exercise science? This, I learned combines coaching, the treatment of injury, the prevention of injury, and body conditioning. Plus lots more.
Sports Nourishment Masters candidates must study anatomy and physiology. They should also take a course in chemistry. To name just part of the curriculum. This is no slough off field.
So what are the job possibilities? Look at this partial list:
independent expert Sports Nourishment to the public,
sports coaching camps,
rehab centers,
fitness centers
diet drinks corporations
personal coaches
diet consultants,
diet consultants and advisers for pro sportsmen
beginners who need to improve their physical performances
concentrate on certain sports or groups of related sports.
consultant job in the gymnasium, as a resource for its members and groups.
pro sports teams and varsities
Lots of possibilities in this field. I believe we have a young man here who is after a real education in an ever growing field. I’m impressed.
Awesome, Garret! Wishing you much success.…

Small Nutrition Changes Which Go a Long Way

A weight loss journey can be one of the most difficult adventures you will ever take. This is especially true for those of us who have to lose a lot of weight. Majority of the time we are so scared and disappointed that we end up quitting long before we even begin; however, if you have the right motivation than anything is possible. In this article I will list several small changes which can help you get stated on your weight loss journey.

Don’t ever skip meals. Doing so leads to overeating and snacking.

Increase your intake of fruits and vegetables. These products are low in calories and high in fiber.

Switch from refined grains to whole grains.

When you have the opportunity to switch to low fat, by all means do so. This is a reference to dairy, condiments and a wide array other products.

Remember that beverages also contain calories. Be certain that you pay attention to the calorie count in everything that you drink.

Eat smaller portions more frequently throughout the day.

Don’t make meat your only source of protein.

Be sure that you consume fish at least twice a week and beans at least once a week.

Always start off with the food which has the least calories. When you have a plate in front of you which has veggies, meat and potatoes, try to fill up on the veggies first.

These small nutrition changes can help you lose weight [] fast and safe, not too quick, not too slow.…

Check Out These Tips And Cure Your Asthma Today!

If you have trouble with asthma, you know that it can make it difficult to participate in some activities, and can have a major impact on your ability to live your life the way that you want to. There is hope, however! Read on to find lots of fantastic tips and tricks to deal with your asthma.

To keep your asthma under control, you should only use non-aspirin pain relievers. Both Aspirin and non-steroidal anti-inflammatory drugs like ibuprofen and aleve can irritate the lungs and worsen the effects of your asthma over time. Tylenol has no negative effects on asthma users, and can be taken regularly without issue.

To make sure you’re getting the most out of your inhaler, hold your breath for 3-5 seconds each time you puff. This will give you time to inhale the medication deeply into your lungs so that it can take effect quickly. Once you have finished holding your breath be sure to exhale slowly.

A good tip that can help your child cope with asthma is to make sure you never smoke around them. It has been medically proven that smoking can cause asthma or make existing symptoms worse. Also, do not let your child around others who smoke.

Asthma can be triggered by cigarette smoke. People that have asthma are most often times very sensitive to it. You should take great steps to make sure no one smokes in your car, in your home, or around you anywhere. This will help you immensely when you are trying to avoid asthma attacks, and stay healthy in general!

When dealing with asthma, you should limit your contact with animals. Many people who have asthma also have an allergy to pets. Even if you do not have an allergy to pets, pets can carry trigger substances, such as dirt, in their fur. These substances could cause an attack without you being allergic to pets.

It is important for asthma sufferers to make sure to get their flu shot every year. Getting the flu can be deadly for anyone, but for asthma sufferers, that chance is greater. The flu virus can cause fluid in your lungs, which in turn, can cause your asthma symptoms to flare up.

If you have asthma and your house is going to be painted, try to leave your house for a few days. Spend some time at a family or friend’s home. The fumes and smells of wet paint can cause asthma symptoms to increase and can even cause serious asthma attacks.

Health Food

Raw apple cider vinegar is an excellent treatment for those who suffer from asthma. Mix two tablespoons with eight ounces of water or apple juice and drink up to three times daily. If you use water, honey can be added to make it more palatable. Look for raw apple cider vinegar in the health food section of most grocery stores.

Now that you have some actionable advice for treating and managing asthma, you’re ready to lead a happier, more productive life. Yes, it will take some effort to keep your asthma under control, but if you can summon the willpower to apply the advice in this article, before long you will be able to do the things you want to do without letting your asthma hold you back!…

Tips On How To Be Free From Depression

One of the most debilitating things to affect humans is depression. Depression bring affected individuals into a melancholy state where they may lose sight of goals in life and lose any hope for their future. If you need help battling depression, then pay attention to the advice in this article.

A great tip that can help you fight depression is to not listen to sad music. A lot of people are drawn to sad music when they’re depressed because it validates their thoughts. This can keep you in a depressed state. Ditch the sad music and you’ll find yourself feeling better.

If you are depressed, it would be best for you not to hang around other depressed people. As the old saying goes, misery loves company. The last thing you need is someone rationalizing and promoting your misery. If you hang out with other depressed people, you will be down in the dumps forever, barring any kind of recovery.

Examine your life. If you are unhappy because you feel like you are being walked on, focus on becoming more assertive. If you find yourself assuming people are thinking badly of you, remind yourself that you are not a mind-reader and that you have no basis for that belief. Keep it light and humorous, as you cannot battle negative thoughts with more negativity.

A support network is absolutely crucial in overcoming and even, in living with clinical depression. Some of the best support groups are now found online on websites known as forums. These are typically formed by other people who are experiencing the same thing that you are and will be able to give you better advice.

If you are suffering from depression, one of the best thing you can do to improve the state of your mental health is to spend time with positive people. The people you surround yourself with have a huge impact on your thoughts and feelings. If you constantly spend time with negative people you will feel negative yourself. Thoughts and feelings are contagious so surround yourself with positive people.

With depression there are many causes. Try to find the root cause of your depression. Once you have identified the source, it is easier to find a solution and to deal with the feelings when they occur.

Fitness

An effective way to resolve and overcome depression is to create some realistic goals that you can achieve. These goals can be anything from learning to play an instrument or setting a fitness goal. By living a more goal oriented life, you will be able to focus more of your thoughts on things that are making your life better rather than the issues causing your depression. Accomplishing your goals will also serve as a vital source for the self esteem and self confidence that you will need to overcome depression.

As stated before in the introduction, depression has a debilitating effect on humans. Depression makes individuals melancholy while removing any hopes and goals they have for life. If you remember the advice found in the article above, you can battle depression and remove your own melancholy state and return your hopes.…

Proper Dental Care For A Healthy Life

When you first meet someone, one of the things that makes a first impression is your teeth. This is just one reason you should keep your teeth in good shape. This article has tips that will help you care for your teeth.

When you are brushing your teeth, make sure that you get all of the toothpaste out of your mouth by rinsing properly. Leaving toothpaste on your teeth can cause buildup, which can negatively affect the health of your mouth. After you are done, give your mouth a good rinse three times with a cup of water.

Stop smoking to improve your dental health. Smoking harms both teeth and gums. It can even discolor your teeth. Smoking disrupts the blood supply to the gums, which makes it harder for them to remain strong and healthy. This reduced blood supply makes it more difficult for dentists to diagnose gum diseases.

There are many different elements that can end up staining your teeth. Coffee, red wine and cigarettes are some of the most common culprits. If you just can not avoid these things, you can drink your coffee and wine through a straw so that it does not hit your teeth. It is also helpful to brush your teeth right after smoking.

It can be quite uncomfortable to be intimately engaged in a conversation with someone who has horrible breath. Maybe it is something they ate, or just plain old bad dental care habits. Whatever the case may be, a good way to help yourself out of this situation is to carry around gum or mints. Have one yourself and offer them one at the same time. This makes a polite gesture a successful covert operation.

If you are having a cosmetic procedure done, make sure you do your research when it comes to the dentist you want to work with. Always ask to see “before and after” pictures of previous patients. It is important that you have a chance to examine your prospective dentist’s skill level before allowing him or her to work on you.

Some people incorrectly assume that the higher price a dentist charges, the better he or she must be. This is not the best way to determine which dentist is your best bet. The best way to find out which dentists are the most skilled, accommodating and effective is to seek recommendations and reviews. Ask friends and family members for feedback on dentists, or search online for more information.

Keep your toothbrush as clean as can be. Otherwise, you may be attracting bacteria to the bristles that then infect your mouth! Wash the bristles after every brushing, and stand your toothbrush upright so that any additional water drains down the brush. Be sure to replace your brush every few months even when you clean it well.

As this article said before, people tend to notice your teeth when they first meet up with you. You need to make sure your teeth are a positive representation of yourself. Use what you’ve just learned, and soon your teeth will look great.…