Difference Between Mg & IU

What is the difference between mg and IU?

Basically Mg is mass......... IU is effect Milligrams (mg) are a measure of mass(weight). A milligram is one thousandth of a gram. International Units (IU) are a measure based on the biological activity of a substance in the body. These units are arbitrarily set by a committee of researchers commissioned by the World Health Organization. The goal is to provide a measure of the effect on the body a substance will have regardless of its mass. For Ex: 1 IU of Vitamin C is 50 mgs, but 1 IU of insulin is .045 milligrams. That's for the pure crystalline versions of those chemicals: a different preparation or a related chemical may have the same effect using a different amount, and that would also be 1 IU. IU is used for vitamins, hormones, some drugs, vaccines, blood products and similar biologically active substances. Despite its name, the IU is not part of the International System of Units used in physics and chemistry.

Forced Degradation (Stress Testing)

Chemical stability is one of the most important issues that impacts the quality and safety of pharmaceuticals. The FDA and ICH require stability testing data to understand how the quality of an API or a drug product changes with time under the influence of environmental factors such as heat, light, and humidity.Knowledge of these stability characteristics defines storage conditions and shelf life, the selection of proper formulations and protective packaging, and is required for regulatory documentation.

Forced degradation studies typically involve the exposure of representative sample of a drug substance or drug product to the relevent stress condition of light,heat,humidity,acid/base hydrolysis and oxidation.Forced degradation plays an important role in the drug devolepment process.It furthers understanding of the chemistry of the drug substance and drug product and facilitates the devolepment of stability indicating analytical methodology.

Forced degradation, or stress testing, is carried out under even harsher conditions than those used for accelerated stability testing. Generally performed early in the drug development process, laboratories cause the potential drug to degrade under a variety of conditions – acid and base hydrolysis, photostability, peroxide oxidation, and temperature – to understand resulting byproducts and pathways that are necessary to develop stability indicating methods.

Testing of stress samples are required to demonstrate the following abilities.
1. To evaluate the stability of drug substance and drug products in solution.
2.To determine structural transformations of drug substance and drug product.
3.To detectlow concentration of potential degradation products.
4.To detect unrelated impurities in the pressence of the desired product or product related degradents.
5.To seperate the product related degradants from those derived from excipients and intact placebo.
6.To elucidate possible degradation pathways.
7.To identify degradation products that may be spontaneously generated during storage and use.

Forced degradation studies are designed to generate product related varients and devolep analytical methods to determine the degradation products formed during accelerated and long term studies.The degradation products observed in such studies are "potential" degradation products that may or may not be formed under relevant storage conditions, but these products reveal the degradation pathways available to the drug and facilitate the development of stability-indicating analytical methods.Any significant degradation product should be evaluated for potential hazard and the need for characterization and quantitation.

Forced degradation studies are designed to generate product related varients and devolep analytical methods to determine the degradation products formed during accelerated and long term studies.The degradation products observed in such studies are "potential" degradation products that may or may not be formed under relevant storage conditions, but these products reveal the degradation pathways available to the drug and facilitate the development of stability-indicating analytical methods.Any significant degradation product should be evaluated for potential hazard and the need for characterization and quantitation.

Forced degradation or stress studies of drug substances are usually conducted in solution and the solid state at temperatures exceeding accelerated stability conditions (>40°C) The degradation pathways investigated include hydrolysis, oxidation, thermolysis, photolysis, and polymerization. Hydrolysis is investigated in solution over a broad pH range and in the solid state by exposure of the drug to high relative humidity. Oxidation in solution can be investigated through control of exposure to molecular oxygen or by addition of oxidizing agents such as peroxides. The effects of thermolysis are usually assessed in the solid state by applying heat. Photolysis is investigated in solution or the solid state by irradiating samples with light with wavelengths in the 300-800 nm range; photooxidation can be investigated with light under an oxygen atmosphere. Drug substance polymerization can be investigated by measuring the rate of degradation as a function of different initial drug substance concentrations in solution and LC/MS analysis of degradation products.

Extend of degradation
A degradation level of 10-15% is considerd adequate for validation of a chromatographic purity assay.

Regulatory and Scientific Guidance by Phase
Although forced degradation studies are a regulatory requirement and scientific necessity during development, they are not considered part of the formal stability program. The guidance gives recommendations for conducting studies at the various phases of development.

Phases 1 and 2
For Phase 1 and 2 INDs, the guidance recommends that degradation studies on the drug substance be conducted for the purpose of SIM development, but there is no explicit requirement to report the findings of these studies in the IND.However, this investigator has had questions from the FDA at the IND stage on degradation chemistry related issues. From a scientific point of view, it is advisable to perform degradation studies on the drug substance in solution and the solid state after candidate selection or as early as feasible. Degradation product identities can be investigated by LC/MS, LC/DAD, or LC/NMR. Peak purity of the API can be determined by one of these hyphenated techniques or through use of orthogonal chromatographic methods. Some attempt to determine mass balance should be made. Isolation and characterization of degradation products is rarely needed this early with the exception for degradation products that are suspected to be very potent. If the molecule is chiral and predominately one stereoisomer, the stereochemical stability of the API should be examined in the degraded samples. Solid-state work should wait until the salt form has been finalized unless a less optimal form will be used in a regulated study. Stressed solid samples should be tested for content, impurities, and physical form. Though rare, there are degradation pathways that occur only in the solid state and then only in some polymorphs.
The guidance recommends only that drug products be stressed photolytically at phase 2.Scientifically, solid dosage forms should be stressed with heat, heat and high humidity, and with light. Liquid dosage forms should be stressed with heat, light, and possibly at different pH if the product contains water and is unbuffered. Stressed drug products should be examined for reactions between the API and excipients using hyphenated techniques. Clear differentiation between drug and non-drug related peaks should be made. Stressing placebo and product concurrently followed by comparison of the respective profiles can facilitate this determination. Degradation studies at this stage can readily afford insight for development of more stable formulations.

The result of forced degradation studies are required to be included in phase-III IND filing.

Generic Drugs (Generics)

A generic drug is a drug which is produced and distributed without patent protection.(generic drugs are manufactured and marketed without a brand name).In practice, generics are often marketed as equivalents to branded drugs.It is possible that a generic drug have a patent on the formulation but not on the active ingredient, in such case formulation can not be taken by any one but the active ingredient can be formulated so as to form a suitable dosage form.


A generic Drug or Pharmaceutical should contain the same active ingredients as that of the original or parent formulation.According to the USFDA generic Pharmaceuticals or generic drugs are identical to or acceptable within an bioequivalent range with respect to pharmacokinetic and pharmacodynamic properties of the to the branded pharmaceutical product. Hence, Generic Pharmaceuticals or generic drugs are considered by US FDA as drugs identical in dose, strength, route of administration, safety, efficacy, and intended use.


US FDA establishes required standards for a generic drug giving a range of acceptable values and range of variations that a generic drug is required to be bioequivalent to a brand name drug .Generic drugs is likely to differ from original brand name drug with respect to inactive ingredients or excipients, its configuration, release mechanisms, packaging shape , scoring.


In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.


Generic drugs are usually sold for significantly lower prices than their branded equivalent. One reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents.Other probable reasons for low cost are
Drug development is extremely time consuming and costly. On average, brand-name drug companies spend about $800 million to discover, develop, and produce a new drug. They then have to charge fairly high prices to recoup their investment and actually make a profit. Generic manufacturers, however, don't have to spend nearly as much on drug development. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company.To gain FDA approval, all a company has to do is prove that its version of a drug is chemically equivalent to the original. If the chemical makeup is the same, it's assumed that the research and clinical trials are as applicable to the generic version as they were to the original.
Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers.When a generic drug can be produced
When a pharmaceutical company first markets a drug, it is usually under a patent that, until it expires, allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be produced without patent infringement for drugs where: 1) the patent has expired, 2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where the drug does not have current patent protection. Patent lifetime differs from country to country; typically an expired patent cannot be renewed. In the U.S., patent extensions may be granted if changes are made; some pharmaceutical companies have sought extensions on things as minor as changes to the shape and color of the pill; generic makers are excluded while the adjudication of the extension is considered. A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials. In addition, a patent on a changed compound does not prevent sales of the generic versions of the original drug unless regulators take the original drug off the market.


The companies most negatively impacted by generic drugs are the pharmaceutical companies who originally develop new drugs. When their patents expire, these companies are usually forced to lower their prices in order to compete with the cheaper generic versions of their products. Major pharmaceutical companies generally charge relatively high prices for their drugs while the patents are in effect, which allows them to recoup their R&D costs and make a profit before generics become available. Nonetheless, generics eventually lead to either lower profit margins or a loss of market share, both of which are less than ideal for drug companies.

Orphan Drugs

An orphan drug is a pharmaceutical agent that has been devoleped to treat a rare medical condition,the condition itself known as orphan disease.For example, haem arginate, used to treat acute intermittent porphyria, variegate porphyria, and hereditary coproporphyria, is an orphan drug.There is a little finalcial incentive for the pharmaceutical companies to devolep medication for these diseases or conditions.


Pharmaceutical companies are constantly researching and developing new medications to treat medical conditions, and new drugs come on the market frequently. People who have rare diseases or disorders, however, have not had as much research attention in past decades. This is because their numbers are small and therefore the potential market for new drugs to treat them (commonly referred to as "orphan drugs") is also small. A rare disease occurs in less than 200,000 individuals in the United States, or less than 5 per 10,000 individuals in the European Union. Government regulatory agencies in the United States and the European Union have thus taken steps to reduce this disparity and offers some financial incentive for the pharmaceutical companies to devolep medication for these diseases or conditions.


The U.S. Office of Orphan Product Development
The U.S.FDA is responsible for ensuring the safety and efficacy of medications on the market in the United States. The FDA established the Office of Orphan Product Devolepment (OOPD) to facilitate the development of orphan drugs (and other medical products for rare disorders), including offering research grants.


Orphan drugs, like other medications, still have to be proven that they are safe and effective through research and clinical trials before the FDA will approve them for marketing.


European Union and Orphan Product Development
Like the U.S. Congress, the EU government recognized the need to increase research and development of orphan drugs. The Regulation on Orphan Medicinal Products, passed by the European Council, provides incentives for the development of orphan drugs.Companies with an orphan designation for a medicinal product benefit from incentives such as:

Protocol assistance (scientific advice during the product-development phase)
Marketing authorisation (10-year marketing exclusivity)
Financial incentives (fee reductions or exemptions);

Over The Counter Drugs (OTC)

                                  
Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care.

There are more than 80 therapeutic categories of OTC drugs,ranging fron acne drug product to weight control drug products.OTC drugs generally have these characteristics.


Their benefits out weigh their risks
The potential for misuse and abuse is low.
Customer can use them for self dignosed conditions.
They can be adequately labelled.
Health professionals are not needed for the safe and effective use of the product.

Wonder Drug

Antibiotic Penicillin is known as wonder drug.The discovery of Penicillin has often described as a miracle,and that is exactly what it was.Prior to the discovery of Penicillin,death could occur in what would seem,today,to be very trival injuries and diseases.It could occur from minor wounds that become infected or from diseases such as strep throat,and ventral diseases such as Syphilis and Gonorrhea were much more serious issue.

The Story of the Discovery of Penicillin

Penicillin was discovered accidentally, at St. Mary's Hospital, in London, by Dr.Alexander Fleming . Fleming was examining a culture of Staphylococcus aureus, a pathogenic bacterium on which he was doing some research, when he noticed that it had become contaminated by a species of Penicillium. Although, the species of the mold was unknown to Fleming, at the time, he did observe that it was inhibitting bacterial growth. Fleming wrote a paper on his findings in 1929 and the rest is history. However, it was never that simple. Such a short summary really does not tell you the entire story, and in this case, says that Fleming's discovery of penicillin was one of chance and does not credit other people, who were just as deserving or more so in the development of penicillin for medicinal use.

Some luck, surely was involved, as is true with many events. Alexander Fleming did not have any ambition to become a doctor throughout his life. His start into bacteriological medicine came from an unlikely string of events. In 1900, when the Boer War broke out between England and colonies in southern Africa, Fleming and two brothers joined a Scottish regiment, which turned out not to be such a dangerous time for them as they had chanced upon a country club environment. They spent much of their time shooting, swimming, and even playing water polo. Following the war, Fleming returned home to discover that his uncle had died and left him and his brothers with a sizable inheritance. His older brother, Tom, who was a successful doctor by this time, advised him to invest his money on his career and suggested that he attend medical school. Fleming scored high on his examination and was able to select from three medical schools. He knew nothing of these schools and selected St. Mary's Hospital, in London, only because he had once played water polo against them. After graduation, Fleming had trained to be a surgeon for just as random a reason, but then found himself in a choice that was even more bizarre. He had the option of taking a position, as a surgeon and leaving St. Mary's or he could join the Inoculation Service and stay at St. Mary's. The major influence on Fleming staying was that the captain of St. Mary's rifle club knew of his option and was desperate to improve his team. Knowing that Fleming was a great shot he did all he could to keep him at St. Mary's. He convinced Fleming to join his department in order to work with its brilliant director and to join the rifle club. Fleming would stay at St. Mary's, where his discovery of penicillin was made, and for the rest of his career.

Prebiotics

A therapeutic nutritional preparation used for gut effects favoring growth of normal bacterial flora and not favoring growth of pathogenic organisms.In other words prebiotics are nutrients which selectively feed the friendly bacteria in the gut.

A quality prebiotic supplement should contain at least three grams of dietary fiber and features additional nutrients that selectively feed the friendly bacteria. These include fructooligosaccharides (FOS), a family of short-chain carbohydrates that deliver an immediate food source to nourish friendly bacteria; and inulin, long-chain carbohydrates that also provide nutrients for beneficial microflora.

Other nutrients in good quality prebiotics include Jerusalem artichoke, a vegetable containing a natural source of inulin and FOS, as well as gamma tocopherol (related to alpha-tocopherol, the most well-known member of the vitamin E family), found in relatively high levels in colon cells. Studies have shown that dietary intake of vitamin E, and particularly gamma-tocopherol, may reduce levels of potentially toxic oxidation products in the colon.

Probiotics (Living Drugs)

 

 

Probiotics (Living Drugs)

 

 

 

Probiotics are live microorganisms or microbial mixtures administered to improve the patient's microbial balance, particularly the environment of the gastrointestinal tract and the vagina.Probiotics have demonstrated an ability to prevent and treat some infections.Probiotics can be bacteria,moulds or yeast.Commonly used bacterial strains are Lactobacillus & Bifidobacterium.Commonly used yeast strain is Saccharomyces boulardii.

The human digestive tract is home to over 400 species of microorganisms, of which some are good ones while others are harmful to our body. Probiotics is the answer to keep the harmful ones at bay. According to the definition adopted by WHO, probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host." probiotics are new generation biotechnology drugs and are considered relatively safe and may exert their action: by producing pathogen-inhibitory substances, inhibition of pathogen attachment, inhibition of the action of microbial toxins, stimulation of immunoglobulin A, trophic effects on intestinal mucosa etc.

Effective use of probiotics could decrease patients' exposure to antimicrobials.Probiotics normally prevent proliferation of pathogenic bacteria in the gut. So whenever they are suspected to be deficient or whenever massive infection of the gut with pathogenic bacteria is suspected, probiotics are administered to counter the balance in favour of probiotics or healthful bacteria.There is also encouraging evidence for the use of probiotics to prevent and treat infections of the urinary tract or female genital tract. Probiotics are also useful in treating irritable bowel syndrome and inflammatory bowel diseases like ulcerative colitis and Crohn's disease.Probiotics are effective for the treatment of antibiotic induced diarrhoea or infectious diarrhoea, travellers' diarrhoea, infantile diarrhoea, constipation, Salmonella and Shigella infections, lactose intolerance and flatulence.

Example
Lactobacillus Acidophilus is the most commonly used probiotic.It inhibit the growth of harmful bacteria.Patients who are suffering from diarrhea are given lactobacillus as a suppliment.It is also used in the treatment of urinary tract and vaginal infections.Cefixime and lactobacillus combination is devoleped to reduce the gastrointestinal side effects of cefixime.

Probiotics are increasingly preferred over antibiotics by doctors. Reason being, antibiotics reduce the immunity of patients, whereas probiotics help enhance immunity.

A good probiotic agent needs to be non-pathogenic and non-toxic, resistant to gastric acid and bile and must reach the intestines alive in large numbers. It should transiently grow in the gut and impart health benefits to the host.

Prokinetic Drug

Prokinetic (gastroprokinetic/gastrokinetic/prokinetic) drug is a type of drug that promotes intestinal peristalsis. They are useful in the treatment of motility disorders in humans and other animals because they induce coordinated motility patterns.


A prokinetic drug enhances gastrointestinal motility by incresing the frequency of contractions in the small intestine or making them sronger without disturbing their rhythm.They are used to relive gastrointestinal symptoms such as abdominal discomfort,blotting,constipation,heartburn,nausea and vomitting.They are used to treat a number of gastrointestinal disorders, including irritable bowl syndrome,gastritis,acid reflux disease,gastroparesis and functional dyspepsia.

Pharmacodynamics
These drugs may increase acetylcholine concentrations by antagonizing the D2 recetor which inhibits acetylcholine release, or by inhibitting the enzyme acetyl cholinesterace which metabolizes acetylcholine. Higher acetylcholine levels increase gastrointestinal peristalsis and further increase pressure on the lower esophageal sphincter, thereby stimulating gastrointestinal motility, accelerating gastric emptying, and improving gastro-duodenal coordination.

Examples
Metoclopramide
Domperidone
Cisapride
Erythromycin
Ranitidine
Nitazidine
Neostigmine
Lidocaine

OSHA

The United States Occupational Safety and Health Administration (OSHA) is an agency of the United States Department of Labour. It was created by Congress of the United States under the Occupational safety and Health Act, signed by President Richard M. Nixon, on December 30, 1970. Its mission is to prevent work-related injuries, illnesses, and occupational fatality by issuing and enforcing standards for workplace safety and health. The agency is headed by a Deputy Assistant Secretary of Labor.
The OSH Act which created OSHA also created the National Institute for Occupational Safety and Health (NIOSH) as a research agency focusing on occupational health and safety. NIOSH is not a part of the U.S. Department of Labor.


OSHA federal regulations cover most private sector workplaces. The OSH Act permits states to develop approved plans as long as they cover public sector employees and they provide protection equivalent to that provided under Federal OSHA regulations. In return, a portion of the cost of the approved state program is paid by the federal government.

ASHRAE

ASHRAE (American Society of Heating, Refrigerating, and Air-Conditioning Engineers) is an organization devoted to the advancement of indoor-environment-control technology in the heating, ventilation, and air conditioning (HVAC) industry.


ASHRAE was founded in 1894 to serve as a source of technical standards and guidelines. Since that time, it has grown into an international society that offers educational information, courses, seminars, career guidence, and publications. The organization also promotes a code of ethics for HVAC professionals and provides for liaison with the general public. One of the most important functions of the organization is to promote research and development in efficient, environmentally friendly technologies.ASHRAE is accredited by the American National Standards Institute (ANSI) and follows ANSI's requirements for due process and standards development.


ASHRAE STANDARDS


ASHRAE develops standards for both its members and others professionally concerned with refrigeration processes and the design and maintenance of indoor environments.These standards are often referenced in building codes and are considered useful standards for use by consulting engineers, mechanical contractors, architects, and government agencies.These are legally unenforceable, but commonly accepted standards for architects and engineers.