At the National Institute on Drug Abuse (NIDA), our goal is to help people get accurate, science-based information about drugs and health. To help you start a conversation about drugs and health, we&#;ve compiled teens' 10 most frequently asked questions from more than 118,000 queries we&#;ve received from young people during National Drug and Alcohol Facts Week®. It&#;s okay if some of this information is news to you&#;lots of other people are asking, too!
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- 10. Why do people use drugs when they know they might cause problems?
Every day we make choices that affect our health. People take drugs for a lot of different reasons, like to deal with life&#;s challenges, to escape from reality, to relieve pain, or to try to fit in&#;just to name a few.
Some people can be aware of the negative effects of drugs on their health and in their life and still struggle to stop using them. This is because repeated drug use can lead to changes in the brain that make it hard to stop using them, even when people want to stop. When this happens, the person is experiencing a medical problem known as substance use disorder. Addiction is a severe form of substance use disorder.
All addictive drugs cause the brain to release the chemical dopamine. Dopamine is usually released after pleasurable and satisfying activities. Dopamine causes the brain to remember rewards, like food and sex, and reinforces the desire to seek them out again. Repeatedly using a drug floods the brain with more dopamine, which can change the way the brain responds to that drug.
With repeated use, a greater quantity of drug is needed to produce the same pleasurable effect. When the drug is not available, people may experience the negative symptoms of withdrawal, which may include stress, anxiety, depression, and sometimes physical symptoms such as sweating, vomiting and pain. Repeated cycles of drug use and withdrawal can disrupt brain function to the extent that people may have difficultly experiencing pleasure in their daily lives. At this point, many people continue drug use to avoid the lows caused by withdrawal rather than seek the highs they once experienced.
Fortunately, treatment can help people with a substance use disorder counteract these disruptive effects and lead healthier lives. The sooner a person receives treatment, the better the chance that they will recover.
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- 9. What are the effects of drugs like Xanax® and Percocet®?
Xanax® and Percocet® are both brand names of prescription drugs. Both can help treat certain medical conditions when used as directed by a doctor, but they have the potential to be misused. They work in the brain in different ways:
Xanax®, or alprazolam, is a prescription depressant that helps produce a calming effect. Many people experience anxiety disorders and have difficulty sleeping, and prescription depressants can help treat these symptoms.
Percocet® is prescribed to treat severe pain from serious injuries or after surgery. It contains the analgesics (pain relievers) acetaminophen (the same drug as in Tylenol®) and oxycodone, which is an opioid analgesic. Opioids affect the brain's reward circuit, causing euphoria (the high), and flooding the brain with the chemical messenger (dopamine) which reinforces the brain to seek out the drug again.
Xanax® and Percocet® can cause severe adverse health effects, including overdose, if taken in large quantities or if taken with certain other drugs. Large doses of acetaminophen in Percocet® can also cause life-threatening liver damage. If you are prescribed these drugs, carefully follow your clinician&#;s instructions, and do not share them with others.
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- 8. What are bath salts?
When teens ask us about bath salts, we understand that they&#;re probably not referring to Epsom salt for a relaxing time in the tub. They&#;re talking about synthetic cathinones, which are stimulants made in labs. Bath salts and similar drugs cause extreme wakefulness and elevated heart and breathing rates. Many people seek out these drugs because they are viewed as a cheaper substitute for stimulants like methamphetamine and cocaine.
Using bath salts can cause severe intoxication, hallucinations, paranoia, panic attacks, and addiction. Serious health effects including dehydration and kidney problems can also occur. An additional danger of taking these synthetic drugs is that they might contain other substances with their own harmful effects, including life-threatening overdoses.
Bath salts are usually white or brown crystal-like powder that are ingested in several ways, though snorting or injecting these drugs further increases the risk of harmful effects.
Despite their health risks, some of these drugs are sold legally in stores or online in small plastic or foil packages with the words, "Not for human consumption." In addition to "bath salts," synthetic cathinones are sometimes labeled as "plant food," "research chemicals," or "glass cleaner."
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- 7. Can you get addicted to ADHD meds?
Many teens who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD) take prescription stimulants like Adderall® or Ritalin® to help treat their symptoms. When taken as directed, these medications can be helpful and safe, and have a very low risk for addiction. If your doctor prescribes stimulants, it&#;s important to follow the instructions and to discuss any concerns about addiction or dependence.
Sometimes people who don&#;t have ADHD take drugs like Adderall® or Ritalin® in an attempt to get high, to stay awake longer, or to stay focused while studying. According to the Monitoring the Future annual survey on teen drug use, there was a significant increase in the misuse of the ADHD medicine Adderall® among 8th graders from to .
This can be especially harmful because people often take these medications at a higher dose or through a different route than prescribed. Misusing ADHD medications can cause headaches, nausea, feeling anxious, and sleeping problems. Misusing prescription stimulants can also lead to addiction. These drugs can also make you feel paranoid, cause your body temperature to get dangerously high, and make your heart beat too fast. While stimulants may help with a lack of focus in some people, they may diminish other skills (like creative thinking).
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- 6. Is vaping bad for you even if it&#;s just flavoring?
It can be. Research shows that many teens and young adults don&#;t realize that the flavors they use actually can contain nicotine, an addictive compound found in tobacco. Many vapes also contain propylene glycol, glycerin, chemical flavorings, and other compounds with unknown health effects. As a result, people who vape&#;even just flavoring&#;may inhale and ingest potentially harmful chemicals.
Recent studies showed that students who had already used any type of e-cigarette by the time they started 9th grade were more likely than others to start smoking cigarettes and other smokable tobacco products within the next year. And we know that cigarette smoking is a leading cause of cancer and other illnesses. According to the Centers for Disease Control and Prevention (CDC), cigarettes cause more than 480,000 premature deaths in the United States each year&#;from smoking or exposure to secondhand smoke. This represents about 1 in every 5 U.S. deaths, or 1,300 deaths every day.
Other vaping products can also cause harm. In , thousands of people got sick and dozens died from an illness called EVALI, which stands for e-cigarette or vaping-use associated lung injury. Vitamin E acetate, an additive in some THC-containing vaping products, is strongly linked to EVALI. When heated and inhaled, vitamin E acetate can damage the lungs.
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- 5. How can I help someone with a problem stop taking drugs? How can I help if they don't want help?
Supporting a loved one through a struggle with substance use can be difficult for adults and teens alike. This process can be especially complicated when someone is resistant to getting help. While you may not have control over someone else's substance use, support is available to cope with how that substance use may affect you.
The Substance Abuse and Mental Health Services Administration (SAMHSA) operates the National Helpline 1-800-662-HELP (). This is a free, confidential, 24/7, 365-day-a-year treatment referral and information service (in English and Spanish). SAMHSA has resources available online for families coping with mental and substance use disorders and also provides a confidential online treatment locator.
If someone is experiencing an overdose, mental health crisis, or another emergency, call 9-1-1.
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- 4. If a pregnant woman takes drugs/smokes/drinks alcohol, what happens to her baby?
Pregnancy is an important time to maintain or adopt healthy behaviors. Decades of research show exposure to certain substances can be unsafe for the health of the woman and the baby. Many drugs, including opioids, alcohol, and stimulants, have been associated with harm to the developing fetus. Using or being exposed to some substances can increase the risk of miscarriage and can cause migraines, seizures, or high blood pressure in the mother. A study found the risk of stillbirth was 2 to 3 times greater in women whose blood tests showed exposure to tobacco and about 2 times greater in women whose blood tests showed exposure to cannabis, stimulants, or prescription pain relievers.2 Pregnant women should refrain from drinking alcohol and talk with their health care provider before using any medicines or drugs.
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- 3. Can marijuana be used as medicine?
Although the medical use of marijuana is legal in many states, the U.S. Food and Drug Administration (FDA) has not determined that the marijuana plant is safe and effective for treating any disease or condition and has not approved it as a medicine.&#;
Although the marijuana plant has not been approved as medicine, the FDA has approved formulations of two of the components of marijuana&#;THC and CBD&#;as medicine for specific conditions. THC, which stands for delta-9-tetrahydrocannabinol, is responsible for marijuana&#;s &#;high&#;, the euphoric and addictive effects of the drug. CBD, or cannabidiol, does not produce a high and has not been shown to lead to addiction.
CBD derived from the marijuana plant has been approved for seizures associated with specific disorders, and laboratory-made THC has been approved to help with appetite in people with AIDS and to treat nausea associated with chemotherapy for people with cancer. Although not available in the United States, a combination of plant-derived THC and CBD has been approved in multiple countries to treat some symptoms of multiple sclerosis.
The National Institutes of Health, including NIDA, continue to support research on the potential medical uses of marijuana and its components. Currently, however, marijuana products (including CBD) are being marketed as treatments for many conditions for which there is insufficient or no evidence of their safety or effectiveness.
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- 2. Which is more habit-forming &#; smoking cigarettes or vaping nicotine?
Nicotine in any form is highly addictive, and many who start using one form of nicotine transition to another.
NIDA&#;s Monitoring the Future survey showed that the number of teens who say they vape nicotine has leveled off but remains high. The number of teens who say they smoked cigarettes in the past month declined significantly since the mid-s and is now at or near the lowest it ever has been. Because both smoking and vaping are so addictive, it is helpful to speak with a doctor when trying to quit either. A good strategy is never to start.
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And the question we receive most often from teens is &#;
- 1. What is the worst drug?
It&#;s only natural to want to know what&#;s best or worst, good or bad. That&#;s why we love these types of lists! But in the case of drugs and alcohol, there isn&#;t a &#;worst&#; just as there isn&#;t a &#;best&#; drug.
We don&#;t define drugs as most or least harmful. All drugs have the potential to produce negative health effects or lead to a dangerous situation in the short or long term. Whether a drug causes a serious health issue&#;like a life-threatening overdose&#;can depend on how much a person uses, how they consume it, and other factors.
However, some drugs are so potent that a life-threatening overdose can occur the first time a person uses them. For example, the synthetic opioid fentanyl is 100 times more potent than morphine and 50 times more potent than heroin. Because fentanyl is often mixed with other drugs, such as heroin, cocaine, methamphetamine, and MDMA (Molly), fentanyl may be ingested unknowingly at unknown quantities, which can lead to overdose. Injecting potent drugs can be particularly dangerous because this route delivers the compounds more directly to the brain than ingesting or snorting drugs. Injection also carries the risks of injury and infection.
Similarly, some drugs are more frequently associated with addiction and dependence than others. For example, more than half of people who regularly use cigarettes meet the criteria for a tobacco use disorder, while only about 1 in 11 people who regularly use marijuana (cannabis) meet the criteria for a cannabis use disorder. Certain drugs can have a stronger effect on the brain than others. Research has shown that methamphetamine, in particular, may damage cells and structures within the brain that can cause long-term problems with emotion and memory.
Certain physical or mental illnesses, as well as family health history, also influence someone's chances of developing an addiction or other negative health effects of drug use. Age is an especially important factor when calculating the risks of substance use. Because the brain develops through a person&#;s mid-twenties, teens and young adults tend to be more vulnerable to negative health effects of many drugs. All of this means certain substances may pose different risks to different people in different situations.
Going by the numbers, determining the deadliest drug also depends on perspective.
In , an estimated 106,699 people died from a drug overdose in the United States. The most common drugs associated with these fatal overdoses were synthetic opioids, including highly potent illicitly made fentanyl.
However, the long-term health effects of cigarette smoking are responsible for more than 480,000 deaths per year. That&#;s about 1,300 deaths every day.
And alcohol is the substance most frequently involved in deadly car crashes. Nearly one person died every 52 minutes from drunk driving crashes in .
To put it simply, what's the "worst" drug isn't an easy question to answer, and it&#;s important to understand the risks of any substance. NIDA supports research to help us understand the effect of drugs on the brain, how to prevent people from starting to use drugs, and how to help them if they have substance use disorder.
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As science advances, Drug Discovery aims to keep fueling new medicines to cure and palliate many ailments and some untreatable diseases that still afflict humanity. But, have you ever wondered just how a new drug or vaccine comes to fruition?
Drug Discovery involves many different phases and processes, from ideation to development to approval. In this article, we&#;ll explain everything you need to know about the Drug Discovery process, including what it is, some common questions, the four major stages, how Early Drug Discovery, Pre-Clinical, and Clinical Phases work, and how Zebrafish can be used throughout the process.
Index:
What is the Drug Discovery Process?
The Drug Discovery process is a very long process that can take up to 13 years. The Early Drug Discovery process typically starts by screening for potentially active compounds. These compounds must have a therapeutic effect on the intended disease, and after identifying them, testing for safety and effectiveness begins.
Typically, only 1 out of every 5,000 drugs make it to the market approval stage. Moreover, out of 5,000 and 10,000 drug candidates, only 250 make it to preclinical testing. Below, we&#;ll answer some common questions about the Drug Discovery process.
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How Long Does It Take To Bring A New Drug To Market?
As mentioned earlier, the Drug Discovery process can be very grueling. This means it might take more than ten years to develop a new drug. This tremendous amount of time needed can be explained by the fact that an active ingredient has to go through many stages, from discovery to approval. An active compound is said to be a safe drug only after in-depth examination and intensive studies.
How Much Does It Cost To Research And Develop A New Drug?
Taking a drug from discovery to the market is a costly process. The journey of discovering a new drug is estimated to cost around $2.6 billion, as stated by a study performed by the Tufts Center. Beyond just the large investment needed to produce a new drug, the process has also become more cumbersome in recent years. In addition, the post-marketing monitoring and development costs are said to be from $312 million dollars, boosting the entire lifecycle of Research and Development to three billion per drug.
Why It Is Important To Reduce Animal Testing Through The Drug Discovery Process?
Before the drug candidates are tested in any form on humans, their effectiveness and tolerance must be proven in cell cultures and animals. If the candidates turn out to be toxic or harmful, they won't have a chance for further development. During this stage, the use of animal models for testing can be reduced to both follow more ethical guidelines, and to save time and money. There are alternative models, like Zebrafish, that are more cost-effective for researchers, while also respecting 3Rs guidelines. We will expand on this topic further below in the article.
What Are the Four Stages of the Drug Discovery Process?
The Drug Discovery Process involves many different stages and series of actions. Typically, it can be divided into four main stages: Early Drug Discovery, Pre-Clinical Phase, Clinical Phases, and Regulatory Approval. Let&#;s explore the major steps that are taken in each of these stages to develop a new drug.
1. Early Drug Discovery
The Early Drug Discovery Process involves many different actions and testing. Researchers collaborate to identify and optimize potential leads to a specific target. Essentially, the leads must elicit a desirable effect on a specific biological target implicated in a disease, in the hopes of treating it. Research at this point is performed in the laboratory using in silico platforms, biochemical assays, cell cultures, and various animal models. This stage flows through these sub-processes: Target Identification and Validation, High Throughput Screening or High Content Screening, Hit Identification, Assay Development and Screening, Hit-To-Lead (H2L), Lead Generation and Optimization, and In vivo and In vitro &#;Assays. Keep reading on to learn more about each of these different steps within the Early Drug Discovery process.
2. Pre-Clinical Phase
In keeping with the four major phases of the Drug Discovery process, the second stage is the Pre-Clinical Phase. In the Pre-Clinical Phase, the substances identified during Early Drug Discovery are refined, optimized, and extensively tested in a laboratory and in animal or alternative models. The aim is to provide sufficient evidence of safety and efficacy before Clinical Trials in humans can begin, and once this point is assured, it is also useful to calculate the appropriate doses to test in humans. Before the Clinical Trials start it must be ensured that the new substance is available in sufficient quantities during the clinical studies. Since only small quantities were previously required, production now has to be adapted to the significantly higher demand in the Clinical Phase.
Regulatory authorities require preclinical studies before submitting any investigational new drug application to progress to Clinical Phases.
3. Clinical Phases
Clinical Trials are composed of four phases: Phase I, II, III, and IV. We will discuss each of these phases in greater detail further on. Nevertheless, in the first stage, the tolerance and safety of the drug candidate will be tested in a very small group of healthy subjects, usually 20 to 80. Phase I aims to answer the following questions:
For these studies, the active ingredient must first be manufactured under GMP conditions. That means strictly controlled according to the guidelines of "Good Manufacturing Practice."
After tolerance and effectiveness have been tested in a small group, phases IIa, and IIb are started to examine the effectiveness, tolerability, and dosage in a larger group. For this, the dosage form is first developed.
In phase IIa studies, the therapy concept is primarily checked (proof of concept); in phase IIb studies, the aim is to find the right dose. Phase II studies usually include 100 to 500 adult patients in the study.
In the last phase before a possible approval as a drug, doctors test the drug on thousands of patients to see whether the effectiveness and safety can be confirmed in many different patients. Interactions with other drugs are also tested. Phase II and phase III studies are typically so-called controlled studies: some of the patients receive the new drug, and another group the previous standard drug.
4. Regulatory Approval
When an active substance completes the Clinical Trials, the data is then collected and analyzed. Then, it can be submitted to the appropriate authorities for review. Before a drug or vaccine can be sold, approval from a national regulatory authority or centralized process is required. Ultimately, only one of a large number of compounds tested makes it through the process of clinical study phases and regulatory tests. Therefore, only one compound is approved as a drug or vaccine.
Post-Market Monitoring
Phase IV studies (also known as Post-Marketing Surveillance Trials) take place after receiving marketing authorization from the authorities. More comprehensive data can be gathered regarding the effectiveness and safety of the new drug. A larger number of patients taking the drug provides much data as well as compares against treatments that are already available. These studies are designed to assess the long-term effects of a drug. In this way, adverse events can be recorded and avoided.
The Early Drug Discovery and Pre-Clinical Phase, Step-by-Step
Now, let&#;s get more in-depth into the different processes that occur during the Early Drug Discovery phase of drug development. We&#;ll review Target Identification, High Throughput Screening, and High Content Screening, Hit Identification, Assay Development, Hit-To-Lead, Lead Generation, and In vivo and/or In vitro assays.
Target Identification and Validation
One of the key factors in designing a good drug is having a crystal clear understanding of the pathogenesis of a disease. A suitable biological target is said to be &#;druggable&#; when a therapeutic molecule, called a &#;hit&#;, can modify its biological activity. Potential targets may be discovered by sourcing available databases and researching public literature. Once a target is identified, researchers validate their suitability for drug development before going through the screening process to identify the hits.
High Throughput Screening
High Throughput Screening (HTS) and High Content Screening (HCS) are often the most important steps toward discovering a drug. Once a potential target has been identified and validated, the starting point can be detected by screening a large number of molecules that can interact with it. An assay must be developed ad hoc, meaning providing data about the effectiveness and selectivity of the molecule. In addition, it has to withstand the fast and reliable testing requirements. HCS can offer richer data than HTS.
Hit Identification and Discovery
To identify a hit molecule, various methods can be used. The hit is defined as a molecule that must interact with the previously mentioned target to result in a desired therapeutic effect. High Content Screening, phenotypic screening, fragment-based screening, structure-based screening, and virtual screening are examples from a large list of strategies used to discover hits.
Assay Development and Screening
High Content Screening (HCS) is based on the novel approach of taking a large number of images using high throughput microscopy. In vitro cell models including image-based cellular assays and even zebrafish embryos (qualified as in vitro) play a central role in the application of HCS in research for new active ingredients. HCS is used for secondary substance screening, lead optimization, substance profiling, identification and validation of effective targets, investigations in the area of &#;&#;ADME (absorption, distribution, metabolism, and excretion), and for toxicity studies in preclinical research.
Hit-To-Lead (H2L)
As we mentioned earlier, a hit is a term used to describe a chemical compound that has a desired therapeutic effect at a known target molecule. Similarly, the lead is the product of the screening process, which can be used in advanced stages.
The Hit-To-Lead (H2L) stage is one of the most essential stages in early Drug Discovery. The main aim of the H2L is to find the appropriate leads to move along the pathway to a final clinically active drug. Researchers refine the initial compounds using different screening methods, such as High-Throughput Screening, affinity selection of large chemical libraries, fragment-based techniques, and target-focused libraries. The screening process aims to reduce the number of these compounds into less and more qualified leads using in vitro and computer-based approaches. The lead properties must be adequate to examine their efficacy in any in vivo models.
Lead Generation and Optimization
Once the lead is generated in the Hit-To-Lead process, the lead optimization will commence. Lead optimization aims to improve the most promising compound products to enhance effectiveness, lower toxicity, or increase absorption.
In Vivo and In Vitro&#; Assays
At the end of the early Drug Discovery stages, the resultant potential compounds must be tested under conditions similar to living cell conditions. Here comes the role of in vivo or in vitro testing. These testing assays are used to test the safety and the potentially toxic effects of a compound using animal models, alternative models, like Zebrafish, or cell cultures.
Clinical Phases and Regulatory Approval: Everything You Need to Know
After the Early Drug Discovery and Pre-Clinical Phase takes place, then the Clinical Phases commence. Let&#;s explore the four main processes that occur during the Clinical Trials and Regulatory Approval Phase. +
Phases I - III Trials
A clinical study typically involves examining volunteers to test new ways to prevent, and treat diseases. In these controlled studies, vaccines and drugs are tested for their effectiveness and tolerability. Active ingredients have to go through 3 Clinical Phases.
PHASE II
In Phase II clinical studies, the effect is tested on people suffering from a specific disease. Up to 500 patients will take part in the Phase II studies. In this phase, not only the effectiveness and tolerability of the drug should be checked, but also the appropriate dosage should be determined.
PHASE II
In Phase II clinical studies, the effect is tested on people suffering from a specific disease. Up to 500 patients will take part in the Phase II studies. In this phase, not only the effectiveness and tolerability of the drug should be checked, but also the appropriate dosage should be determined.
PHASE III
If the drug has successfully passed Phase II, it will be further investigated in a larger number of patients in Phase III clinical studies. The aim is to show that the drug offers the desired effectiveness in many patients. Rare side effects can also be discovered during this phase.
If Phase III is successful, the manufacturer can apply for approval for the drug - that is, official permission to put the drug on the market.
Pharmacokinetics and Pharmacodynamics Analysis
Following the administration of a drug in an in vivo experiment, drug dynamics data within the body will be derived and described. This analysis is known as pharmacokinetics (PK) and Pharmacodynamics (PD) analysis. This process is very important because it enables the determination of dosing and regimes.
Bioanalytical Method Validation
The validation of bioanalytical methods involves quantitative determinations of the corresponding analyte in biological matrices such as urine, saliva, blood, etc. The validation of such quantitative determinations of the analyte e.g. drugs in development or their metabolic products or biomarkers is crucial for the successful implementation of pre-clinical and subsequent clinical pharmacological studies. Validated methods provide important information regarding the safety and efficacy of the relevant drug under development.
Regulatory Approval and Post Approval
When the development of a drug is almost completed, the approval documentation is drawn up and submitted to the competent authority. This procedure is very time-consuming because all results of the drug testing have to be presented in extensive documents. The approval authority checks all data and decides on approval. The essential prerequisites for approval of a drug are adequate pharmaceutical quality, therapeutic effectiveness, and safety. To do this, the drug must have a favorable risk-benefit ratio, which means that the desired drug effect should be accompanied by as few and harmless side effects as possible. The risk-benefit ratio is the most important approval criterion that is weighed up by the responsible authorities. Even after approval has been granted, the risk-benefit ratio should be continuously monitored. If it changes, this has an impact on the approval. In the worst-case scenario, the drug even has to be withdrawn from the market.
In the course of the authorization process, a very important document is also produced: the &#;Summary of Product Characteristics.&#; This document contains all of the important information for patients about the area of &#;&#;application, contraindications, dosage, interactions, and side effects.
FDA Regulatory Approval
The FDA is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting and promoting public health. To achieve this, the FDA controls the safety and effectiveness of all drugs.
For the FDA to approve a drug, it means that the data regarding the drug&#;s efficacy and safety must be reviewed by the CDER (Center for Drug Evaluation and Research). Moreover, the drug must be proven to provide more benefits than any known or potential risks. The FDA regulatory approval process goes within a very strict-structured process that includes the analysis of the target condition and available treatments, assessment of benefits and risks from clinical data, and strategies for managing risks.
The Benefits of Zebrafish for Ethical and Cost-Effective Drug Discovery Process
In the last few decades, new alternative models have become available to replace traditional animal models. One of the most beneficial alternative models is Zebrafish. Zebrafish embryos and larvae are completely transparent. Thus, by using just microscopes, researchers can look into the internal bodies of the animals without harming or injuring the embryos. Zebrafish are a strong alternative model for Drug Discovery for many reasons including the following:
Zebrafish can be grown very easily
They can be housed in large groups
They can produce 200-300 eggs per fish
The embryos can hatch two days after fertilization; all the vital organs of the fish will mature five days later and will have taken up their function.
In just two to three months later, the young fish will reach sexual maturity to be capable of breeding new offspring.
Keep reading to discover more benefits of Zebrafish, including their adherence to 3R regulations, and how they function as an alternative model.
How Zebrafish Fall Under the 3Rs
The 3Rs &#; Replacement, Reduction, and Refinement &#; are embedded into the legislation and guidelines governing the ethics of animal use in experiments. The Zebrafish is a great option for following the 3Rs model.
Replacement
Zebrafish embryos and larvae are used in the research instead of rodents because apart from their high genetic homology, they are not considered an in vivo experiment until they are 5 days post-fertilization.
Reduction
The sample size must be large enough to give sufficient results; the Zebrafish can produce 200-300 eggs per fish and HCS assays can be performed.
Replacement
Are the least invasive methods used? The Zebrafish embryos are transparent, so they can be monitored and examined harmlessly.
Why Zebrafish Are a Good Alternative Animal Model
Zebrafish grow incredibly fast, are small yet strong, and have many organs and genes in common with humans. Scientifically and genetically speaking, s studies have shown that 70% of Zebrafish genes are found in human cells. Moreover, 84% of disease gene homologs are shared between humans and Zebrafish. This is what makes the Zebrafish platform an extremely ideal alternative for preclinical research involving human diseases, including gene silencing and toxicity assays.
Conclusion
By now, you are surely more familiar with the entire Drug Discovery process. From Early Drug Discovery to Pre-Clinical Trials, Clinical Trials, and Regulatory Approval, the Drug Discovery process is a long, but necessary system that helps to improve lives and advance science. Fortunately, with new alternative models, this process can be more cost-effective and shortened while also adhering to more ethical practices.
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