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.

House Extensions – Things You Need To Know

Rather than moving to a new house, every budget conscious homeowner desires to extend or upgrade their existing home to save both time as well as money. Home additions are a perfect choice for increasing your living space and adding property value. A home extension substantially increases the functional space inside your home and undoubtedly increases the property’s resale value to a great extend. However, before you jump into a final decision, here are some important points to consider regarding a home extension procedure.

Is it a wise choice?

Are you looking forward to an extra bedroom, a new living area for the whole family to enjoy or for a home office? The first and foremost step is to verify the viability of a house extension procedure in your property, no matter whether it is a single storey extension or a two (double) storey extension. Always keep in mind that only a well-planned sensible design can be cost-effective and provide you the likely benefits. Before you proceed, it is also necessary to recognize the need of a planning permission and verify whether your property is located in a conservation area. If so, it is highly recommended to seek advice from your nearby building control authority and do a research about the legal procedures related to the extension work.

Next, take time to find an answer for “how much does an extension cost?” For this, your exact requirement has to be analyzed in detail. Based on your need, you can either choose a rear extension or a side extension procedure. A single storey extension, either done on the side or rear portion, is comparatively cheaper and it requires only minimal disruption. However, if you need more ventilation, then a double storey extension is considered as more beneficial. An extra investment is often required when you adopt additional painting or interior design services. Also, make sure to implement adequate safety measures, before your home remodeling job, to avoid unexpected costs.

As there are multiple possibilities in a home or kitchen extension project, it is extremely essential to find a reputable professional who utilize highly sophisticated construction methods for a hassle free home improvement job. Such professionals inspect your site and suggest the most suitable design pattern, based on your specific requirements, budget and the building’s pre-existing conditions. Moreover, they adhere to essential quality standards and offer adequate work warranty for the job undertaken to ensure utmost customer satisfaction.

What Is Dry Powder Carpet Cleaning?

You have many options when looking for a carpet cleaning method to use in your home. One of the options that is relatively new is the dry powder carpet cleaning method. It is a popular method but most people have no idea how it works or even if it works. This article will try to explain the process and the positive and negative characteristics of it.

In this process of carpet cleaning, a semi moist power is spread onto the carpeting. The powder which is soaked in a detergent and/or solvent solution is usually either a corn cob based organic powder or a fully synthetic powder. This powder is agitated and worked into the carpet with either an orbital floor machine with a round plastic bristle brush or a machine with counter rotating plastic brushes. The theory behind this method is that the powder acts like thousands of little sponges scrubbing and absorbing dirt from the carpet as it is agitated. After the powder dries, in only a few minutes, the carpet is vacuumed to remove the sponges and the floor is ready to be used.

The biggest positive characteristic of this method of cleaning is that it dries extremely quickly. Its drying time can be measured in minutes instead of hours. This means that you do not have to struggle to keep your kids and pets off of the carpet until it dries. You can put your home back to normal use almost immediately. Another benefit is that since the carpet is not being soaked with water, this method does not force spots down only for them to return hours or days later. What you see is what you get.

Dry powder cleaning does have some negative characteristics as well. For starters, the powder is usually not completely removed. The powder does not harm your carpet but the dry powder granules can stick to bare feet and can be a little bit of a nuisance. It is also not as aggressive as some other carpet cleaning methods. It is therefore best used on light to medium soil conditions.

That is pretty much all there is to this method. Hopefully this article has given you enough information to decide whether or not this it is for you.

Understanding the Importance of a Probate Lawyer

Many people often neglect to make arrangements for their estate and finances in the event of their death. Failure to draft a will can cause a great deal of complexity when it comes to handling the deceased’s affairs and could result in the estate becoming “tied up” in legal proceedings for several years. San Diego probate lawyers specialize in the probate area of law, and understand the limitations and legal proceedings that probate entails.

Probate occurs when an individual estate has no will or set of legal instructions to direct the disposition of one’s affairs. Knowing how assets are going to be divided, debtors taken care of, property disposed of, charitable bequeaths are all handled by the probate court. This is done before the Superior Court of California for the County of San Diego in the Probate Court, which a San Diego lawyer could navigate with efficiency

Probate is of chief concern for the heirs and beneficiaries of individuals whose loved one dies without a will. Dying without a will, known as dying intestate, leaves it up to the probate court to decide what happens to the person’s estate. A person leaves an estate, whether there is money or assets or anything else that is tangible upon death. The San Diego probate lawyer understands the system for disposing of a decedent’s affairs and resolving the competing concerns of the heirs.

Settling matters such as these in a probate court can take anything from months to years. This is usually due to the amount of time it can take for heirs or beneficiaries to step forward, in the event that none can be easily located. Not only will a San Diego probate lawyer try to resolve the matter as fairly as possible, but they will resolve to get the process over as quickly and efficiently as they are able to.

A legal background in wills, estates, trusts and probate are a must for an attorney practicing probate law. Looking at a individuals background and credentials is helpful. Checking online legal directories and asking questions also helps to ensure that the San Diego probate lawyer you higher is competent.

Oregon Real Estate Investments

For generations, people have made investments to secure recurring revenue from it, in the years to come. Though there is no formula to ensure a profitable return, a large number of individuals opt for such income sources. Similar to other places Oregon real estate investments are, a booming business opportunity for real estate companies. A unique factor of real estate investments is that they are largely influenced by local factors. This includes local events and situations that affect the popularity of an area. Unfortunate events such as car bombings can result in adverse returns, for Oregon real estate returns on investments for a short period. On the contrary, a simple rock show can send profits soaring.

The popularity of Oregon real estate investments depends, upon events that occur in and around a locality where a property is situated. For this reason, localities that are already popular or favorable prove to be higher “price point” investments. Statistics reveal that expensive investments are likely to offer higher returns. This is because posh locales have the reputation of housing individuals with a higher “spending capacity.” Apart from local factors, Oregon real estate investments are also affected by global recession and inflation.

Oregon real estate investments refer to any property, barren land or land that has permanent buildings and fixtures upon it. They are not used as residential properties and can be sold if needed. Most investors rent such real estate to guarantee a regular source of income. At times, these returns can even exceed the cost of an investment. It includes apartment buildings and rental houses that generate income. It also refers to barren land that is fenced and can be rented out as a parking lot, even. So long as it provides a return, it is looked upon as an investment property.

Rainy Days and Leaking Basement Problems

We all love the rain. Nothing beats hanging out on your lounge, just sipping a cup of warm soup and listening to the pitter patter of the rain as it steadily hits the window panes. The crispness of the air and the cold breeze makes you want to just laze around the house and enjoy it with your loved one. Yes, we all love the rain, unless the rain itself brings us big problems with our houses, like damaging the foundation of the house or flooding the basement. This presents us with a lot to contend with, especially if we have not done anything to waterproof our foundation.

This would be a real drag, since a lot of our furniture would be damaged, and would be rendered useless. Flooding in the basement would account for a big cut in the budget, since we really have to get it fixed before another downpour of rain comes along. A large amount of work and effort will be expended to at least save some of the things that basement floods have damaged so the best solution to basement flooding, of course, is prevention.

A vast array of techniques have now been introduced to flood-proof our basements. From putting up our houses on sloping ground that would propel the water away from the foundations, to putting baseboard systems around the foundation, you can never really go wrong if you prevent flooding from happening. Sump pumps have also been introduced. This system keeps the water from coming into your home by pumping them out before it even reaches the basement floor. You also have to constantly check for cracks in the walls of the foundation and prevent them to keep the water out of your basement. Concrete sealers are now introduced in the markets, to help the concrete keep out water. Try putting the waterproofing coat on the foundation first before doing the actual landscaping, because if you don’t, you will be forced to dig about six feet into the ground next to the foundation just to apply it. Waterproofing materials need to be applied onto the foundation itself for them to work.

These preventive techniques should at least save you from bigger difficulties once the rain sets in. If you have done all the steps to ensure a flood-free basement, you can truly enjoy the rain with your warm cup of soup and your sweetheart beside you.

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.

Things To Know About Home Improvement Loans

Owning a home is a dream-come-true for most people, but sometimes home repairs and maintenance can be a burden. Some repairs cannot be put off and home repair jobs must be done as they appear. If you do not have the money for major home repairs, a home improvement loan is your best option.

A loan for home remodeling provides access to cash that can be used to make renovations or additions to a private home. The loan can only be used to finance projects that will benefit the house or property. All the work done must be for the maintenance of the real estate or to increase its worth.

Home loans are usually short-term loans. The interest rate depends upon the lending institution and the personal credit of the borrower as well as the home value and home mortgage.

Purpose of the Home Improvement Loan

Cash from a loan for home improvement can be used for projects such as home repairs, new bathroom or kitchen, building a deck, landscaping, repainting, redecorating, updating plumbing, installing a swimming pool, adding a room, etc.

Acquiring a Home Improvement Loan

Private lending institutions offer these types of loans. There are also federally funded programs for this type of loan. You can speak with a customer service representative for information about acquiring a loan.

Before you go to a lender, be sure to have all the details of the project ready. You will need the estimated total cost of the project and quotations from potential contractors. You must also include the expected increase in home value, if applicable.

Home improvement projects can be financed through home equity loans or home equity line of credit. You may also opt for refinancing and unsecured loans. Veterans can apply for a VA Home Improvement Loan to upgrade their current home. This type of loan is backed by the Federal Government to lending institutions that offer home improvement financing.

Choosing a Loan to Finance Home Improvement

Each type of loan has its own advantages and disadvantages. It’s up to the homeowner to decide
which one suits their needs best. One of the deciding factors in choosing a loan is the interest rate. Secured loans with the borrower’s property as collateral generally have a lower interest rate.

For small home repairs you may want to take out a personal, unsecured loan. For major construction, however, it may be more beneficial to apply for a homeowner’s loan. You will find many lending institutions that can offer financing for a home loan. Obtain quotes from different lenders and choose the one with the best offer.

Free Grant Money For Home Repair and Improvement

The government provides free grant money for a lot of different reasons, and home repair grants are one of the many ways that American citizens can take advantage of these programs. Depending on the programs your local community government offers, and the state or federal grant programs you choose to apply for, you could receive the cash you need to fix and update your home for free.

What exactly does it mean to get money for free? Just that. When obtained, this is cash that you can spend and will never be asked to pay it back. That is, of course, as long as you use the funds for the intended purpose of the grant.

You can visit your City Hall to check with your local government agencies and inquire about the home grants that you may qualify for. Some of the grants that are available will provide you with the cash you need to completely rehabilitate your house or even expand your home. Other grants may help you pay for labor or material costs. In some cases you may simply receive a tax credit for installing energy efficient appliances.

Whatever the case, there are numerous government grants available, and home improvement grants are just a small sliver of the money that has been allocated to be given away. And since this is money that never has to be repaid, it may very well be worth some minimal effort in finding the cash that is available for you to claim.