INVESTIGATIONAL NEW DRUG REVIEW PROCESS Investigational New Drug Review Process Prashanth Kumar Ponugoti Northeastern University INVESTIGATIONAL NEW DRUG REVIEW PROCESS Abstract Investigational New Drug (IND) review process begins from the time the sponsor files investigation new drug application and the purpose of the review is to confirm the safety and efficacy of the patient for the drug. Moreover in the process of review if the review committee notifies any deficiencies by the
Premium Clinical trial Food and Drug Administration Drug development
In the mid to late 1800’s‚ opium was a fairly popular drug on the market. It was the drug of trade and it was even more popular than alcohol. Opium dens sprung up all over and it became a serious problem. The addictive effects became unbearable. By 1874 to a new wonder drug called Heroin was invented to ease those who became addicted to morphine which is a derivative of opium. Heroin was believed to be a safe and non-addictive substitute for morphine. They were wrong and the heroin addict was born
Premium Heroin Drug addiction Addiction
Running Head: DRUG COURTS AND THE TREATMENT OF SUBSTANCE Drug Courts and The Treatment of Substance Abusing Offenders Traci R. Howard Guilford Technical Community College Drug treatment courts also known as Drug Courts‚ provide treatment services to offenders in the criminal justice system. These particular courts use various models to provide treatment to drug offenders such as strategies to assist offenders with recovery from substance abuse. The process
Premium Crime Drug addiction Criminal law
effective treatment to stop drug addiction or do addicts return to their ways? Dan Frosch‚ a New York Times writer‚ reflects on an issue concerning jails and detention centers nationwide‚ drug addiction. His article‚ “Plan to End Methadone Use at Albuquerque Jail Prompts Alarm” focuses on the effects‚ costs‚ and realities of methadone treatment. Frosch adopts a sentimental tone in order to appeal to similar feelings and experiences within his audience. Moreover‚ Frosch effectively uses ethos‚ pathos
Premium Drug addiction Addiction Heroin
Drug addiction counseling and treatment have recently become a popular topic of discussion and pop culture. We can simply turn on the TV in many cases and see celebrities as they go through rehab. On another channel‚ we might find family members urging an individual to find treatment in an intervention. While the treatment programs presented on these television programs typically feature a paradisiacal treatment location offering a number of leisure activities‚ this is often misrepresented. Here
Premium Addiction Psychology Drug addiction
Effective Treatment for Drug Addiction Introduction “Every year‚ hundreds of thousands of Americans undergo treatment for substance use disorder‚ also called addiction” (Hart & Ksir‚ 2013‚ p. 409). Drug addiction is a complex brain disease because the abuse of drugs leads to changes in the structure and function of the brain. It is a condition characterized by an overwhelming and uncontrollable desire or craving to continue taking a drug to which one has become habituated through repeated consumption
Premium Drug addiction Addiction Substance abuse
Nowadays the use of drugs is very common in our life. There is no precise definition for drug‚ as the meaning of it follows according to how the users intend to use it. Some may called it medicine but some may called it death‚ but the main purpose of drugs is actually to reduce pain or kill some cancer cells in our body. Unfortunately‚ many people especially those uneducated teenagers tend to misuse drugs. They have no idea how it can both harm them physically and mentally. I would say that the
Premium Caffeine Recreational drug use Coffee
Protective and risk factors behaviours of young people related to drug use. My health issue is drug use. Young teenagers goes through the phase of adolescence when they have to start making decisions relating to themselves and their health too. Sometimes this procedure of making decisions can be hard for them as there are protective and risk behaviours associated with it which they might or might not be aware of it and ignore it as most of the people do. Protective behaviours are those
Premium Health Psychology Mental health
Jason Green April 24‚ 2013 ADC150 History of Alcoholism Treatment The view on alcoholism has changed dramatically throughout history. The way to treat it has also changed. There are many withdrawal symptoms that made it hard to treat. Today therapy and medication or regular attendance at meetings of Alcoholics Anonymous is the primary treatment. In the past there have been many different ways to treat alcoholism and many failed attempts. According to the Web MD website withdrawals can start
Premium Alcoholism Psychosis Alcohol abuse
Effective Treatment Scientific research since the mid–1970s shows that treatment can help patients addicted to drugs stop using‚ avoid relapse‚ and successfully recover their lives. Based on this research‚ key principles have emerged that should form the basis of any effective treatment programs: Addiction is a complex but treatable disease that affects brain function and behavior. No single treatment is appropriate for everyone. Treatment needs to be readily available. Effective treatment attends
Premium Addiction Drug addiction