Category: Health

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:…

What Is The Single Most Important Factor In Losing Weight?

Turn on the television, browse through a magazine, look at the shelves of your local pharmacy, and you’re inundated with quick fixes to any potential weight problem. It doesn’t matter what the approach is, or who the experts sponsoring it are, the claims are the same: stick to this approach for a short time and you will see results.
Some diets aim to strike all carbohydrates from your diet, filling you up on only protein. Others provide simple instructions to drink some of your calories, and you’ll stop feeling hungry through the majority of the day. Other people swear by eating cabbage soup (or some other specific food) as a way to shed the pounds.
Regardless of the fad, all such approaches share the same inherent flaw – the fact that they’re all diets. The idea of a diet is straight forward: eat specific “good” foods and restrict yourself from “bad” foods. The problem is that at some point (whether it’s in a week, a month, or a few hours) “bad” foods will fall back on your plate. Any progress made will be quickly reversed.
Think back to every diet you’ve ever tried. Early on, the going is relatively smooth. The weight starts to drop off as you remove forbidden foods from your diet. Then you start to plateau. Or you’re constantly faced with those same foods that your body once used to rely on and are tortured by the temptation.
Gradually, you sneak in one of the forbidden foods, claiming that you’ll start dieting again tomorrow. But tomorrow never comes as one forbidden food becomes two – and the initially promising attempt to lose weight becomes a miserable failure.
And yet, whatever reason for stopping, months after one fad diet has failed you, you’re on the hunt for the next. Before you know it, you’re filling your grocery cart with cabbage (or whatever), hoping that the answer lies in never-ending meals of soup or Tabasco sauce or the latest grapefruit concoction.
That’s the diet side of the health industry. The other side of the equations is the fitness industry. For every quick-fix diet, there’s an equally compelling exercise program promising that in only a few minutes, hours, or routines later, you can have the body you’ve always dreamed of.
Exercise fanatics believe the gym is the real means to long-term weight success. Less dependent on what you’re eating, the true change in health, in their view, comes from how many calories are being burnt out of your system. These claims are just as straight forward as those of the diet gurus: put a small amount of work in, and see the amazing results.
The typical exercise-to-lose-weight program takes a similar course to that of the fad diets. The initial interest carries results, but a plateau eventually occurs. Or because you’re now burning more calories, you also eat more food – and the net result is zero.
For every one of us who’s tried a fad diet, we’ve also tried the quick fix exercise route. The end result is the reason that the health industry is one of the fastest-growing in our nation. Quick fix exercises don’t work, forcing you to go out and try another. Upon plateau, the exerciser or dieter starts to doubt that those washboard abs or slim thighs are going to come before the next millennium, let alone summer. Dwindling motivation, fading dedication and a busy life start to intervene, and the best-laid plans become only that. Action takes a back seat until next January.
I’ve always believed that exercise and nutrition go hand in hand. While exercise is important, the real key to losing weight and keeping it off lies in what you eat. I’m not talking here about a fad diet. I’m talking about a complete nutritional lifestyle change – a holistic approach to weight loss that takes into account that you will most likely fall off the wagon, eat out at restaurants, and plateau in your journey to lose weight and get healthy. Exercise helps, but it doesn’t get you all the way. What you eat is the single most important factor in losing weight.…

The 5 Principles Of Scott Pilates!

Introduction:

Moira Scott Merrithew was in fact the founder of scott pilates. Following badly injuring her neck, Merrithew set up a Pilates styled approach identifying it scott pilates.

You will find 5 fundamental principles overseeing the Pilates program that an experienced person may use to help students with their exercises. The concepts provide step-by-step training about the appropriate body positioning and also breathing techniques.

Breathing:

To allow smooth movements through the scott pilates workout routines, correct breathing is crucial. The breathing pattern that is stressed concentrates on complete, heavy breaths till the respiratory system is full before breathing out.

Being in tune with this kind of breathing, you should begin by lying flat on your back, whilst paying attention to your normal respiratory rate. Pay particular attention to where your breath begins and where it finishes.

Next sit down on a comfy seat, lean forwards and wrap your arms around the knees.

Breathe deeply and then move completely in so that you are making a “C” curve with your spine. Breathe out and get back to up-right position.

Placement Of The PELVIC:

Scott pilates concentrates on the stabilizing of the pelvis and the spine by protecting a neutral position.

This helps to keep your back in-line, for instance whenever lieing face up with your feet positioned on the floor, your hips ought to be set at an angle toward the position of your lower back on the ground.

If your legs are raised off the floor, keep up with the same position,

This position is called the “imprint position” and it needs to be kept through the majority of the workouts.

Placement Of The RIB Cage:

Your rib cage is equally as crucial as the pelvis, since it impacts the positioning of your spine. You need to focus on your rib cage resting lightly on the mat whilst face up using your pelvis in the correct position.

You mustn’t feel as though you’re forcing this position. Your ribs must feel secure and protected when breathing properly.

Steadiness Of Shoulders:

Several of the Pilates workouts take the form of sitting upright from a laying position.

So it is critical that the shoulders are positioned together with good shoulder placement,this results in healthy posture for the hips and abdominal muscles. Choosing a comfortable shoulder location implies not raising them too high, neither should they be pressed downwards; they need to not be drawn backwards nor hunched forwards.

Picture your shoulders to be broad and straight. Possessing this way of thinking will help you in quickly moving through the scott pilates workout routines.

Placement Of Neck And Head:

The positioning of your neck ought to be focused on length along with the natural curve of the spine.

This position shouldn’t be stretched or forced. Whenever possible, the neck ought to be kept straight and above the shoulder blades and the spine. Because of the regular shifting from laying to seated positions throughout Pilates, you need to lengthen y our neck in practice by nodding with out forcing the chin towards the chest.

This particular mode of practice will help you in focusing on your own stomach muscles instead of the neck or shoulders.…

Reasons to Avoid Sugar

Unfortunately, in today’s society we have been brought up with a high sugar intake from a young age. This does not necessarily mean we eat lots of sweets; sugar is present in a lot of the processed foods we consume. This includes things we eat every day, like bread, mayonnaise and peanut butter. Here are a few reasons why we should be more careful with what we eat:
Sugar has the potential to cause greater problems
If you are taking in more sugar than what your body is supposed to have, you are at risk for diabetes, which is a lifelong irreversible disease. Many people do not know that high sugar intake causes cholesterol. By not knowing you have high cholesterol and not starting a proper diet you stand a chance of having a heart attack.
Sugar can make you sick more often
By eating a lot of sugar it weakens our immune system, which means if there is a nasty bug going around the office, the chances are higher of you getting sick. Vitamins are always good to take, irrespective of how much sugar we eat.
Sugar causes weight gain
Unfortunately, the chocolate you just ate is going to sit on our hips. We don’t like to think of these things, but the fact is refined sugar is scientifically very bad for us. Weight gain is also extremely bad for your health.
No more energy
By eating too much sugar in your day without a balanced diet can cause you to have decreased energy levels. Many people think that eating a chocolate bar will provide them with energy, but actually the opposite is true. It gives you a quick rush of energy only to have it taken away drastically; you will feel lethargic.
Aging twice as fast
Sugar can literally make you age twice as fast. If you are eating too much sugar it can causes wrinkles faster than when you are limiting it in your diet.
Something extra to note
Sugar does not necessarily have to be cut out completely; it can be eaten in moderation as a treat with friends. If you cut it out completely, people will just crave it more and find others way to have it, like binge eating or eating in secret. This can have far worse consequences, so make sure to balance your food choices and limit your sugar intake. Healthy food with enough vitamins and minerals should out way the amount of junk food consumed. If people are exposed to too much junk food and not enough healthy food they can experience vitamin deficiencies. You will be surprised at how bad this can be, especially young children.
What you should be doing
It is highly important that you include all food groups in your meal. This can seem very hard when you are currently not following any healthy eating plan. It is beneficial for the entire family but most importantly for a growing child to receive the right nutrition. There are certain vitamins you should be taking, you can easily buy a variety of ones from any online health store.…

Your Child’s Toothpaste Needs Minimum Fluoride Content for Most Affordable Dental Care

Affordable dental care is not the easiest thing to find. One of the best ways to keep dental costs low is to always use preventative measures.

The best oral hygiene habit may be brushing your teeth with fluoride toothpaste.

There are a couple of reasons to brush with fluoride toothpaste:

It can prevent dental decay. Using this kind of paste is a great way to protect your teeth from cavities or any form of dental decay. The Cochrane Oral Health Group which is based at the School of Dentistry at the University of Manchester has shown that these pastes reduce tooth decay by 24% more than non-fluoride products.

You can prevent more costly treatments. Brushing with fluoride can protect yourself from expensive procedures such as root canals — brushing your teeth is a simple route to affordable dental care.

A warning against the over-use of fluoride

According to a study by The Cochrane Oral Health Group, children under six years who ingest large amounts of fluoride in the form of toothpaste have a higher risk of developing fluorosis. That is a good reason for children under six years to not using a toothpaste with a high fluoride content.

Fluoridated toothpaste can cause fluorosis. Though it can protect your mouth, this helpful chemical can also be harmful if used excessively. Fluorosis is a condition caused by ingestion of excessive amounts of this chemical. It can cause discoloration or mottling of the teeth, especially in children.

This situation is avoidable if you get a toothpaste with a healthy fluoride content. In that same study, it suggested having a toothpaste with a lower concentration. The study recommends that children use a toothpaste with no more than 1,400 parts per million (PPM). This is key to avoiding fluorosis and maintaining affordable dental care.

Get a toothpaste for your child that has no more than 1,400 PPM and no less than 1,000 PPM of fluoride. If the toothpaste has more than 1,400 PPM, it can cause fluorosis. This is something to avoid for both the sake of health and for the appearance of your child’s teeth. If the toothpaste has less than 1,000 PPM, then only as effective as non-fluoridated toothpaste at preventing tooth decay.

Once the child is past six years old, the potential danger of getting advanced fluorosis has past. It may still be a good idea to keep the fluoride content of your toothpaste low for other health reasons and so that you can maintain affordable dental care. Make sure that your toothpaste is in the 1,400-1,000 PPM range, and you will get all the benefits of this tooth-protecting chemical with less of the risk.…

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.…

Childhood Nutrition – Taking a Closer Look at the Mixed Messages We Send Our Kids

Children’s nutrition is a loaded subject. At no other time in our lives is building a solid foundation for health more important. Yet, at no other time in our lives are we so completely at the mercy of others making decisions for us.
That means it’s up to the grown-ups in a child’s life to understand the importance of healthy food (and beverage) choices in order to introduce healthy habits to their children.
Easier said than done! It seems as though, in the case of children’s nutrition specifically, the simplicity of healthy choices becomes muddled with strange connotations of what a “happy childhood” should be and what our oftentimes skewed views of food are as adults.
Our society is familiar with the concept of an early window of opportunity to teach children things like foreign languages or a skill, like playing a musical instrument. We’ve heard that children are at peak developmental stages very early in life, and therefore we should maximize their opportunities by teaching them these advanced concepts at early ages.
Whether you agree or not, have applied it with your children or not, it’s a socially acceptable concept that seems to make sense to most people. It’s peculiar that, as a society, we don’t yet understand that the very same principles apply to the health of a child.
The early developmental years are a critical time for creating a solid foundation for nutritional health, as well as movement and mindset. What we feed our children (or what we passively allow them to eat or others to feed them), and what we teach our children about nutrition NOW will impact their health for the rest of their lives.
Our family is certainly not perfect in any way, including our nutritional choices. But, we stick to a few basic principles overall in an ongoing, concerted effort to make the healthiest choices possible. We apply the simple Wellness Formula to all of our lifestyle choices, including the nutritional ones.
The Wellness Formula describes how health is created and how sickness is allowed to develop. In order to create optimal health and function, we must make pure and sufficient choices. As described by Wellness expert, Dr. James Chestnut, these are things that meet our body’s innate genetic requirements for health. The two types of choices that move us unequivocally away from health are toxic and deficient ones. Toxic choices are things that work against our body’s efforts to create health – they are not requirements for health.
In applying this to children’s nutrition, we simply talk about what food choices the body truly needs in order to build a strong, healthy body and a brilliant mind, as opposed to which choices are interfering with our body’s efforts and are leading to a loss of health. Kids get this. There are building blocks for health, and then there are things that come by and destroy what you’ve been building. You get to choose.
Another concept that works around here is, “fill up with health first”. It’s not about saying you can “never” have that cookie or that birthday cake or that less-than-healthy food choice. It’s about making sure you’ve given your body what it needs first – the raw materials for building health. If you know you’re going to be eating something more toxic later in the day, then make sure you fuel up with lots of healthy choices first, that’s all.
It’s also about teaching responsibility and accountability to kids when it comes to their health. There are limitations to matter! They can’t fill up with health first, then choose toxic garbage every single day. That’s too much for our physiology to overcome. A toxin is a toxin, no matter how much broccoli preceded it!
As grown-ups, we sure do pass on some odd beliefs and customs to our younger generation regarding food. One example is how we talk about food. When a food choice obviously doesn’t create any health, and in fact moves us away from health, should we really be calling it a “treat”? Isn’t that completely mixed messaging we’re sending our children (and ourselves)? It’s not a treat if it’s contributing to chronic illness!
Let’s call it like it is. How about a “tasty toxin”! (Thanks to Dr. Chestnut for that little gem!) Sure, it tastes great… and you should go ahead and enjoy it in that moment once you’ve made the choice. But let’s be perfectly clear – it’s not good for you and making that choice with any regularity has devastating consequences over time.
That’s the crux right there. If we truly understood the consequences of the choices we’re making on behalf of our children, we’d choose differently. If we clearly understood the consequences of that toxic choice, maybe we’d pass on it. If we clearly …