Journey of a Drug: Design to Market Seller

Where do the medicines we take from chemists come from? How do the doctors know which drug is good for which disease? How the medicines really are able to cure a particular ailment they have been prescribed for? Do these questions come to your mind, whenever you buy any medicine?

Come, let us today know about the medicine development from the beginning

The development of medicine is called a Clinical Research and has different Phases. Phases of the clinical research are the steps of experiments with a health intervention in an attempt to find enough evidence for a process which the scientists think would be helpful in medical treatment.

The pharmaceutical study starts its journey from a drug design and drug molecule discovery which further progresses into animal testing and then human studies to see the drug’s effectiveness.

Drug undergoes many trials- Preclinical, Phase 0, Phase I, II, III and IV. Sometimes combined trials also are undertaken to reduce the time of development, like Phase I/II and II/III.

Pre-Clinical Study

When the drug molecule is identified, it undergoes many in vitro (test tube or cell culture) and in vivo (animal) experiments. These experiments are conducted to know the preliminary efficacy, toxicity, and pharmacokinetics of the various doses of the drug. Many drug molecules are designed at a time and these pre-clinical studies let the pharmaceutical companies decide which molecule has a greater potential in further studies.

Design of the Studies:

Trials are always conducted by following the set of steps, called the protocol, developed by the researchers to find the specific questions related to the medical product. Information from the prior studies become the base for the researchers to develop research questionnaire and objectives:

  • Participant selection
  • Number of participants
  • Duration of the study
  • Controlled or not
  • How and what dosage will be given
  • What and when the data will be collected
  • Review and analysis time

Phase 0 Study

It is also called micro-dosing trials, 10-15 human subjects are taken and single sub-therapeutic doses are administered to gather the pharmacokinetic (PK) data of the drug. This enables the company in deciding to go or no go for the further development of the drug, based on more relevant human data instead of animal data.

Such trials exceed the speed of promising drug development by establishing whether or not the drug acts on humans as expected in pre-clinical studies.

After the company decides to take the molecule of the drug forward in development, it will have to submit the data of its preliminary studies to the FDA called Investigation New Drug (IND) application filing.

Phase I Study

Also called First-in-man studies as these are the first stage of human testing studies. These are the studies which are designed to determine the maximum dose that can be administered without showing adverse effects.

Contract Research Organizations (CROs) conduct such studies in the clinical trial clinics where medical staff provides full-time attention to 2-100 healthy subjects enrolled for the study and collects the data.

These studies determine the safety (pharmacovigilance), tolerability, pharmacokinetics (PK)and pharmacodynamics (PD) of the drug. The design of Phase I studies is dose-ranging also called dose escalation studies conducted in controlled clinics called Central Pharmacological Units (CPUs).

Usually, healthy subjects are hired but sometimes terminally ill patients like of cancer and HIV and also those who have already tried and failed to improve on existing medications.

There are two divisions for Phase I study:

Phase Ia: Single ascending dose

Phase Ib: Multiple ascending dose

Phase II Study

More than 100 diseased subjects are enrolled for a longer period study, to know the benefits of the drug along with its safety which includes genetic testing. These studies are also called as “Proof of Concept or Pilot” studies.

This is the phase when the drug’s development can fail due to toxicity or less than expected results.

Two divisions of this phase are:

Phase IIa: Pilot study, to determine the clinical efficacy or the biological activity.

Phase IIb: Dose-finding study, to check the biological activity with minimal side-effects.

A combined trial determining the efficacy as well as toxicity are Phase I/II trials.

Phase III Study

These are pre-registration trials means the data of this study is submitted to the regulatory agency through New Drug Application (NDA) for its registration. Also called Pre-marketing or Pivotal trials.

Such studies are multi-central, randomized, in large diseased population (more than 500) with much longer duration of treatment and short follow up period, to determine the long-term safety and efficacy of the drug.

Even if the regulatory submission is pending, the drug is received by the patients in case it’s a lifesaving drug until the drug can be purchased.

‘Label expansion’ that is drug can treat an additional disease, other than the disease for which the drug is already approved, may also be the reason for running the Phase III trial.

It is said that for FDA (United States Food and Drug Administration) and MHRA (United Kingdom’s Medicines and Health products Regulatory Agency) needs at least two trials of successful trials data to register the drug.

After these trials, the drug is approved for market selling.

Phase IV Study

These are Post Market Safety Monitoring studies done after the drug is registered. Also called Late Phase or Confirmatory trials.

This kind of study determines the long-term adverse effects on the much larger population for a very long duration (at least 2 years). If harmful effects are detected in this study, then the drug is disapproved and the company has to retrieve the drug from the market as it can no longer be sold.

The entire journey of the drug from a molecule to a market selling product takes around 15-20 years.

Analysis to Next Generation Sequencing Technology

With the development of science, traditional Sanger sequencing has failed to meet new requirements of low cost, high throughput and fast in speed.

Recent years, with the discovery and promotion of second-generation sequencing technology, the gene sequencing speed has increased greatly while achieving a substantial decline in costs, making large-scale application of genome sequencing possible. Now, the cost of personal whole genome sequencing is about 5,000$, and is expected to decreased to less than $ 1,000 in the next few years.

The rapid development of sequencing technology will promote the massive accumulation of DNA sequencing data, accompanied by the accumulation of the corresponding individual diseases, signs and other data at the same time. When we accumulate enough data, how to understand these data will be critical. On the micro level, generations of molecular biologists’ studying the effects of apparent biological traits genes exert on utilizing technologies like gene knockout have made breakthroughs in many crucial aspects. On the macro level, statistics and other data analysis techniques are introduced to study the relationship between gene sequences and biological phenotype. The accumulation of basic scientific research gradually brings breakthroughs in clinical applications.

There are now two types of clinical applications mainly, one aims at disease screening of ordinary people. It infers people’s future risks of getting cancer by measuring the known genes associated with a disease loci. The other aims at the diagnosis cancer and other deadly diseases. It finds in a series of drugs or plans the most effective one for certain patients by testing the loci of certain genes.

Data from BBC research shows that total global gene sequencing market increased from $ 7.941million in 2007 to $ 4.5 billion in 2013, and will reach $ 11.7 billion in the year of 2018 with the CAGR up to 21.2%.

Currently, the market of de novo sequence platform is mainly taken by several major manufacturers, including the Illumina, Ion Torrent / Life Technologies (was the acquisition of Thermo Fisher in 2014), 454 Life Sciences / Roche, etc.

Under such a circumstance, the next generation sequencing technology (second-generation sequencing) appears. As an emerging industry, the next-generation sequencing technology can be applied in clinical testing like antibody discovery, health industry, industrial and agricultural use of gene-oriented study as well as scientific research and development.

To stimulate the next generation sequencing market, we need to start by investing more small and medium size industry focusing on this field.

Health Care For Everyone; What is the Incentive to live a Healthy Life?

If everyone gets free health care what is the incentive to live a healthy life, eat right and work out every day? Why bother? After all if there is free health care for everyone why not just wait to you have a medical problem and then go get fixed, why bother to work out? Why bother to walk around the block every day; why bother to jog?

Do you see the problem with universal health care in the United States of America paid for by the government and our tax dollars? The entire idea is flawed. Personally I don’t want to pay for people who do not take care of themselves, do not exercise, abuse alcohol and drugs and eat crappy foods.

That is not fair to me and I should not have to pay for them. They don’t care so, why should I? And why should my taxes go up so people that don’t take care about themselves can abuse yet another government social program? Now you are probably saying; yet you Republicans; always complain about taxes and you never have a solution.

Well I say to you, I do have a solution and it is a really simple one; let’s give tax incentives for people who exercise, eat right and do not do drugs or abuse alcohol. Let’s reward people for getting back in shape and in the long run we will be Bucks ahead with a whole lot less people in our population with major medical issues down the road.

What Causes Color Blindness

Vision and the ability to differentiate between colors in the spectrum are extremely essential in order to meet day-to-day chores of life. Human eye contains two specialized kinds of photoreceptor cells namely rods and cones that actively participate in regulating these activities. Any abnormalities or errors in these cells can result in the individual being unable to identify colors, a medical condition better known as color blindness or color vision defect.

Abnormalities in the color vision can occur either due to genetic disorder or acquired.

Genetic defects or inherited disorders are primarily as a result of mutated genes. Inherited color vision defect is primarily an X-linked disorder that is mostly prevalent in males. This is because males have only one single X-chromosome while females carry two sets of X-chromosomes. Hence, if the X-chromosome transferred to the male contains mutations that can cause color blindness, the child is definitely going to suffer from the disease. In case of females, chances of both the chromosomes carrying mutations are practically negligible. There are three different types of inherited color vision defects; namely monochromacy, dichromacy and anamolous trichromacy.

There are different reasons due to which a person can acquire color blindness and color vision defects. Some of these include any disease in the eye, injury to the retina, ageing, injury to the optic nerve, damage to the brain, damage caused due to excessive exposure to UV radiation or even as a result of side effects of certain medications.

Defects in the color vision were first identified and reported in 1798 by John Dalton, an English chemist. As a result, these diseases are sometimes referred to Daltonism. Today, detection and diagnosis of color blindness is extremely simple and easy. There are certain specialized color vision tests such as pseudoisochromatic plate tests and arrangement tests that are routinely used to screen for inherited color blindness disorders.

The Best Health Tips for 2011

In the New Year, most people want to get distinctions when it comes to their health. Health must be cultivated and this is a season to begin applying new things as well as old things that have fallen on deaf ears regarding healthy choices. The following is a highlight of the best yet simple health tips for this New Year. First, let us look at what you want to achieve before putting the tips into action.

1. You want to remain positive and happy; feeling good about yourself and life in general.
2. Another thing you will appreciate is promoting weight loss to shed a few
3. Your energy levels may be low or very low and increasing energy and activity will improve the quality of your life.
4. You also want to rid anxiety and find an effective yet natural way to keep you above the water in this regard.
5. This year, you want to do everything possible to keep lifestyle conditions like diabetes at bay.

The good news is that you can achieve all the above by doing the following each day or constantly.

* First, to activate the feel-good hormones that will keep you away from depression and other negative emotions, you need the right brain foods. Oily fish and avocados are the best foods that you can take every day to achieve and maintain optimism and joy in your life.

* Green tea will not just help you loose the pounds you want this year but will also help keep away or reduce the chances of developing cancer. Sugar-free green tea is best. However, natural honey can be used to add wholesome sweetness.

* Co-enzyme Q10 is formulated to help increase energy levels. Consult with your health care provider with this respect.

* Calcium or magnesium will actively work to reduce stress and anxiety. Vitamin B complex is also advised to do the same. Supplement as directed by an expert to see the results.

* Chromium supplements are known to reduce the risk of getting diabetes. The supplement will make sure that you do not constantly crave for sugar.

Above tips for this year are enough to activate your life and get you on the right path regarding health. Getting out and about and keeping the right attitude will help many sail through the year healthy and happy.

An Appreciation of Louisa Lust – Teaching Naturopathy

Many times in a business it is a married couple who work together to produce stellar results. This was the case with Louisa Lust (1869-1925). The wife of celebrated naturopathy Benedict Lust she worked with him to open the American School of Naturopathy in New York.

Before the partnership Louisa already had a name in the nature cure world and used time honored traditions as:
o Hydrotherapy
o Vegetarian diet
o Air and light baths
o Rational life style

German born Louisa studied the nature cure methods of Rikli and Kuhne in London prior to moving to the United States. She established a practice in the USA but continued her studies at Columbia Institute, then in 1901 married Benedict Lust. Their 25 year partnership established Naturopathy as a medical force with lasting impact in the United States. As a cook she prepared tasty meals and wrote: Practical Naturopathic Vegetarian Cookbook in 1907. She tells us:
o A large part of food among Americans is composed of white flour, sugar, and butter. People who try to live on such stuff gradually starve to death
o We lengthen our life with a frugal diet
o We shorten our life by eating too much
o Feed the sick little so little digestive work is needed

Louisa was dedicated to bring out the attributes of a healthy home where light, air, cleanliness, and a good diet would keep a person healthy. She believed in a common sense approach to health that trusted “The Life Force Within”. That what people needed was:
o Freedom from fear
o Mastery of hygiene

Louisa made sure she knew the individual and correspond treatments to their circumstance and experience. Louisa believed there was no better treatment than hydrotherapy and the use of water. If an acute disease struck to use a steam bath, and every day take a cool bath. She believed that fever was the vital force trying to get rid of toxic materials and poison and not to stop it. She advised no solid food and the organs will cure the issue naturally. Louisa Lust spent her life in the pursuit of helping others help themselves. Her lessons are still valid today.

Glomerulonephritis: How to Diagnose and Prevent It at Various Levels

Glomerulonephritis is an inflammation of the glomeruli in the kidney. The glomeruli is constellation of small blood vessels in the kidney that act as a filter to remove excess fluid, electrolytes and nitrogenous wastes from the blood into the urine.

It is divided into:

  • Acute Glomerulonephritis- The symptoms develop suddenly.
  • Chronic Glomerulonephritis- The symptoms develop gradually.
  • In glomerulonephritis, the glomeruli lose their filtering capacity thus blood proteins and red cells are excreted in the urine in various quantities depending on the severity of the glomerular damage.

DIAGNOSIS OF GLOMERULONEPHRITIS

Accurate diagnosis is essential in the successful treatment of glomerulonephritis.

Diagnosis is highly dependent on the clarity of symptoms, examination and investigation findings.

SYMPTOMS

  • Passage of coca-colored urine due to the presence of red blood cells in the urine. This is called haematuria.
  • Passage of foamy urine due to excess amount of proteins in the urine. This is called proteinuria.
  • Presence of peri-orbital and ankle swelling.

EXAMINATION FINDINGS

  • Peri-orbital and pedal edema.

ยท Elevated blood pressure.

INVESTIGATIONS

  • Urinalysis-This reveals diagnostic findings such as red blood cells, casts, white blood cells and proteins in the urine.
  • Blood test- Blood level of electrolytes, urea and creatinine. This is mainly done to assess the extent of kidney damage.
  • Radiological imaging tests-This is done usually when the blood tests suggest some level of kidney damage. E.g Renal scan or abdominal CT scan is done.
  • Kidney biopsy- This entails using a clinical procedure to extract some pieces of kidney tissues for microscopic examination. This is the only test that confirms glomerulonephritis.

TREATMENT

This is based on the following principles:

  • Treat underlying health conditions quickly.
  • Use of corticosteroids to reduce the degree of inflammation and immunological responses.
  • Dialysis- This is used for individuals with acute kidney injury or kidney failure.
  • Anti-hypertensives such as ACEI, ARBs- This is used to control hypertension in some selected individuals.

PREVENTION STRATEGIES

There are 3 levels of prevention namely: primary, secondary and tertiary.

PRIMARY PREVENTION

The aim of this is to prevent the onset of glomerulonephritis.

It entails the following:

  • Throat swab should be done for suspected bacteria cause of sore throat. If streptococcus is suspected, oral penicillin should be commenced as soon as possible.
  • Prompt treatment of individuals with bacteria endocarditis.

SECONDARY PREVENTION

This involves early diagnosis and prompt treatment of glomerulonephritis.

It specifically entails the following:

  • Routine urinalysis to be done periodically for individuals at risk of streptococci infections and for individuals greater than 40 years.
  • Periodic monitoring of blood urea and creatinine levels should be done for individuals with compromised kidney function.

TERTIARY PREVENTION

This involves activities and interventions put in place for individuals with glomerulonephritis from developing complications such as kidney failure and to reduce the disease progression.

  • Optimal control of co-morbidities like hypertension and diabetes mellitus.
  • Reduce intake of high protein diet.
  • Restrict salt intake.
  • Cessation of smoking.
  • Regular clinic follow up by a Nephrologist.

Finally, glomerulonephritis is a very lethal kidney disease of which the onset and progression can be prevented if an individual adheres to the activities in the various levels of prevention highlighted above.

Making Use of Your Doctor

When a busy person goes to see his doctor, it is because he wants to get better. This may sound obvious – but often things happen so quickly, or the tests and treatment sound so complicated, that one can lose sight of one’s original goal. It can even happen that one ends up feeling worse than one was before!

Here are some practical hints to help you get the best possible treatment from your own doctor. Decide before you actually go to see your doctor, in what way you are feeling unwell. Plan how you will describe these symptoms to your doctor. Thinking about them beforehand and even writing down exactly what bodily changes you feel which make you think that you are unwell, will help clarify things in your own mind and so will help your doctor get a clearer picture of what is going on. Remember – doctors can only diagnose from the information which you, the patient, reveal to them!

Don’t underplay your symptoms – either because you feel that the symptoms are trivial, or because you are frightened that they will cause the doctor to suspect that you have some serious disease. This may sound silly but I have met patients who did not reveal to their doctor that they had a lump in the breast “because it might have been cancer”. It is far better to voice one’s fears to the doctor, get him or her to do a full examination and reassure you that you have no serious cause for worry(or, on the other hand, detect in its early stages some major ailment) rather than keep one’s symptoms hidden.

At the same time, don’t exaggerate your symptoms either.

Things To Keep In Mind When Choosing Laser Resurfacing Treatment

Gone are the days when you had to undergo invasive cosmetic surgery to take years off your skin. Today, laser resurfacing treatment helps to do away with wrinkles, fine lines, blemishes and the appearance of pores in a faster and more efficient way. Here are a few things to keep in mind, when opting for laser resurfacing procedure.

The Time When You Have Laser Treatment Conducted

Laser treated skin is more sensitive to sun exposure for at least one year after you perform the procedure. Many surgeons recommend going in for acne scar treatment and other kinds of skin treatment during the winter months. This is because, daytime hours are shorter and you spend most of your time indoors.

Laser Treatment May Or May Not Hurt

Most patients and doctors tell you that the pain can resemble a rubber band snapping against your skin. But all in all, it depends upon the area and depth of treatment, the laser and an individual’s endurance level. Some types of skin treatment require an anesthetic injection or intravenous sedation.

Choose Your Laser Treatment Professionals Wisely

It goes without saying that skin tightening, microdermabrasion or laser hair removal is the most effective and result oriented when performed by a qualified professional. An amateur won’t be able to offer accurate and desirable results. Opt for a professional based on their qualification, experience and training.

Your Skin Reacts To Certain Medications after Laser Treatment

Make sure your practitioner is well aware about your medical history and the kind of supplements and medication you are currently taking. A surgeon, who is unaware about your situation, can unknowingly prescribe medications which can cause skin reactions. It is best to keep all your cards on the table to avoid complications and speed up recovery.

Consider Going In For Multiple Treatments

Sometimes you may need more than one treatment to feel satisfied with the results. In these situations you need to be patient, take your prescribed medications and ensure you follow the doctor’s advice to the T. Once the treatment is complete, you are sure to be rewarded as the results you obtain are long lasting.

If you are thinking about going in for a laser treatment, make sure you consult a knowledgeable and well experienced professional who knows the nuances that go into these kinds of procedures. Rest assured, you get the skin you want and look younger even though age tells you otherwise.

Dubai Health Care Statistic News

An international trade builds one alternative to exporting service is to import customers. Cross border travel for medical services in Dubai is a growing market in health care delivery, stimulated by demand from aging consumers in affluent nations. UAE can offer inexpensive but high quality treatment in modern hospitals is creating a boom in health care tourism in Dubai. The biggest and the most significant part of the health care system in Dubai takes place in dentistry. Lots of people all over Europe and Dubai residents prefer make their glam smile in Dubai. They can even combine dental treatment and recuperation with a vacation.

Nobody has collected the complete worldwide statistic about how many people travel to Dubai for dental and medical care related reasons every year or how many they spent. But UAE general report pointed out that in 2000, medical patients alone spent over 27$ billion. If the medical travelers from around the world spent in UAE even half as much that year, the total business in 2000 alone would have been in excess of 40% billion.

More importantly, Dubai is growing rapidly and turning out to be an immense opportunity for nations to come and have their dental treatment there. Most insurance companies in Dubai have already accredited hospitals and private clinics where visitors can seek emergency medical treatment. Now a few hospitals in Dubai are going a step further – they are getting themselves accredited by the Join Commission Accreditation of Health Care organization. A full accreditation from this organization allows a hospital to pitch for the insurance traffic too. Traveling has never been so healthy before.