Developing Clinical Study Budgets: Fill & Download for Free

This is because of long and tedious process which is needed for development of drug prior to it's approval by regulatory agencies . Idea is to ensure that drug should show it's effectiveness in a convincing manner and effects should weigh over side effects before it reaches market .Process of drug development involves various stages :• in Vitro/Cell-based studies• in Vivo/Animal Model studies• Phase 1 trials -• Phase 2 trials• Phase 3 trials• Approval• Phase 4 trialsNinety percent of new chemical entities (NCEs) entering clinical trials fail, more than 80 % fail at phase 1 and 2 levelPhase 1• Initial introduction of an investigational new drug into humans• Usually conducted in healthy volunteer subjectsPhase 2• Phase 2 includes early controlled clinical studies conducted to obtain some preliminary data on the efficacy of the drugPhase 3• Phase 3 studies are expanded, controlled, and uncontrolled trials.• These studies usually include several hundred to several thousand peoplePhase 4Phase 4 trials are done after a drug has received a market approval. These trials are monitoring drugs that are available for doctors to prescribe, rather than experimental drugs that are still being developed.Pharmaceutical companies run Phase 4 trials to find out:• More about safety and side effects of the drug• What the long-term risks and benefitsClinical research and trials are conducted at multiple sites all across the world in different patient populationThis all involves huge resources and big budget . But in the end if we have a drug which is helpful to mankind then it's worth the money and sweat !!

Activated charcoal is an ancient medicinal remedy. In 1999, the American Academy of Clinical Toxicology concluded (see below from 1, emphasis mine),'In conclusion, based on experimental and clinical studies, multiple-dose activated charcoal should be considered only if a patient has ingested a life-threatening amount of carbamazepine, dapsone, phenobarbital, quinine, or theophylline.'Thus, activated charcoal is an antidote with an enviable track record of saving lives in cases of accidental poisoning. However, all manner of health fads are a moneymaking goldmine these days for a whole bunch of gifted marketers. Inevitably, activated charcoal got co-opted into the detox trend (Detoxification (alternative medicine) - Wikipedia) and charcoal lattes, juices, croissants and even pills sprouted across fashionable watering holes in recent years.However, activated charcoal has no part in daily food intake and could be dangerously counter-productive since it's indiscriminate in what it adsorbs. Nutrients, medications, vitamins, minerals, antioxidants, etc. could thus be prevented from being absorbed by the body. Rather than promoting health, such effects are adverse. Something medically useful isn't necessarily helpful as part of daily diet.As an article in The Conversation points out (see below from 2),'Everyone is looking for a quick fix to wellness, and while we are all struggling with maintaining our energy levels, eating well and exercising while living busy lives, it is easy to be sucked in by clever marketing and celebrity endorsements.The detox market is huge and highly misleading. While the common perception is that our daily lives and dietary habits (including alcohol intake) cause a build up of “toxins” in our system, there are no products or diets that will impact on this, regardless of their marketing budget or how many “influencers” tell you otherwise. We are often sold the idea that our diets are somehow “toxic” when the reality is that, aside from ingesting poison, even fast food doesn’t contain anything toxic.You already have the means to detoxify your body (your liver and your kidneys do a fine job of this), so don’t waste your money. The last thing you want to do is make your food less nutritious by adding an unnecessary, indigestible compound.'Who needs activated charcoal to routinely detoxify their body? Someone without a liver and kidneys, i.e., no one (see below from 3).Brief History of Medicinal & Public Health Uses of CharcoalAn Egyptian papyrus from 1550 BCE is supposed to describe the medicinal use of different types of charcoal while Hippocrates and Pliny are reported to have used wood charcoal to treat a variety of conditions ranging from epilepsy to anthrax (4).Carl Wilhelm Scheele - Wikipedia is considered to have discovered the property of Adsorption - Wikipedia in the 18th century. How charcoal works to detoxify poisons helped regularize its use , and in the process, in a small but tangible way, helped create the modern world. For example, Paris, France, was a pioneer in developing modern municipal water treatment plants and its earliest systems used filters containing different types of sand and charcoal to filter the water (5).In 1813, a French chemist named Michel Bertrand dramatically demonstrated the life-saving antidote ability of charcoal by swallowing a teaspoon of it mixed with 5 grams of arsenic trioxide, a 150X lethal dose of arsenic (see below from 6).'Two European scientists, in heroic experiments, publicly demonstrated its protective properties. A French chemist, M. Bertrand, first experimented with charcoal in animals. Then in 1813 he survived without ill effect after he swallowed lethal dose of arsenic mixed with charcoal.Then in 1830, P. F. Touery, a French pharmacist, swallowed with impunity 10 lethal doses of strychnine in a demonstration before the French Academy of Medicine.'Over the centuries, doctors began to better understand charcoal's antidote effect. While it has decent adsorption ability, treating it in specific ways converts it to 'activated' charcoal, which has strikingly superior adsorption capability. In the early 20th century, Raphael Ostrejko patented processes for enhancing charcoal's adsorption ability by treating it with superheated steam or carbon dioxide (7, 8). These days charcoal is usually heated in the absence of oxygen and under pressure. This creates millions of gaps between the carbon atoms that make it a sponge that can effectively adsorb toxins.Bibliography1. American Academy of Clinical Toxicology, European Association of Poisons Centres and Clinical Toxicologists. "Position statement and practice guidelines on the use of multi-dose activated charcoal in the treatment of acute poisoning." Journal of Toxicology: Clinical Toxicology 37.6 (1999): 731-751.2. Activated charcoal doesn't detox the body – four reasons you should avoid it3. sciencesense4. Cooney, David O. Activated Charcoal: Antidote, Remedy and Health Aid. TEACH Services, Inc., 2016.5. Mays, L. W., M. Sklivaniotis, and A. N. Angelakis. Water for human consumption through history. IWA Publishing, London, UK, 2012.6. CHARCOAL POWDER TERMED ANTIDOTE7. US739104A - Process of obtaining carbon of great decolorizing power. - Google Patents8. GB106089A - Improvements in the Production of Decolourizing Charcoal. - Google PatentsThanks for the R2A, Jonathan Brill.

Important to know how drugs are developedThe process is long and tedious prior to approval of any new drug by regulatory agencies . Idea is to ensure that drug should show it's effectiveness in a convincing manner and it's effects should weigh over it's side effects before it reaches market .Process of drug development involves various stages :• in Vitro/Cell-based studies• in Vivo/Animal Model studies• Phase 1 trials -• Phase 2 trials• Phase 3 trials• Approval• Phase 4 trialsNinety percent of new chemical entities (NCEs) entering clinical trials fail, more than 80 % fail at phase 1 and 2 levelPhase 1• Initial introduction of an investigational new drug into humans• Usually conducted in healthy volunteer subjectsPhase 2• Phase 2 includes early controlled clinical studies conducted to obtain some preliminary data on the efficacy of the drugPhase 3• Phase 3 studies are expanded, controlled, and uncontrolled trials.• These studies usually include several hundred to several thousand peoplePhase 4Phase 4 trials are done after a drug has received a market approval. These trials are monitoring drugs that are available for doctors to prescribe, rather than experimental drugs that are still being developed.Pharmaceutical companies run Phase 4 trials to find out:• More about safety and side effects of the drug• What the long-term risks and benefitsClinical research and trials are conducted at multiple sites all across the world in different patient populationThis all involves huge resources and big budget . But in the end if we have a drug which is helpful to mankind then it's worth the money and sweat !!Copied and pasted from my own answer somewhere :Kirnesh Pandey's answer to Why does it take around $1 billion and up to develop new drugs?