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PERSPECTIVES OF DRUG MANUFACTURERS INVESTIGATIONAL NEW DRUG AND NEW DRUG APPLICATIONS Richard P. Kusserow INSPECTOR GENERAL OEI-12- 90- 00771 FEBRUARY 1990 ... EXECUTIVE SUMMARY PURPOSE The purose of this report is to describe the perspectives of selected drg manufacturers regarding Foo and Drug Admnistration (FA) review of investigational new drg (INDs) and new drg applications (NAs). This is one of several reports being issued by the Offce of Inspector General (OIG) in connection with.
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Investigational FAQ
Psychoactive drugs are substances that, when taken in or administered into one's system, affect mental processes, e.g. perception, consciousness, cognition or mood and emotions. Psychoactive drugs belong to a broader category of psychoactive substances that include also alcohol and nicotine.
Drugs affect the body's central nervous system. They affect how a person thinks, feels and behaves. The seven main types are depressants, psychedelics, stimulants, empathogens, opioids, cannabinoids, and dissociatives. Depressants slow down the messages travelling between the brain and the body.
Biological models of addiction emphasize the importance of genetics and the biological forces of nature. These theories suggest that brain chemistry, brain structure, and genetic abnormalities cause human behavior. Many of these models have not been tested or applied to every specific type of addiction.
Behaviorists explain drug use and addiction by emphasizing the way that these behaviors are learned or habitualized. ing to social learning theory, which holds that behaviors are learned through imitating and observing others, someone might be peer pressured into trying drugs for the first time.
Three perspectives on addiction recur in the psychoanalytic and addiction literature: addiction as a biologically mediated disease, addiction as a response to inability to tolerate affect, and addiction as an object or transitional object equivalent.
What biological factors increase risk of addiction? Biological factors that can affect a person's risk of addiction include their genes, stage of development, and even gender or ethnicity.
Drugs or alcohol can hijack the pleasure/reward circuits in your brain and hook you into wanting more and more. Addiction can also send your emotional danger-sensing circuits into overdrive, making you feel anxious and stressed when you're not using the drugs or alcohol.
Biological reasoning also involves searching (and researching) the causes of biological phenomena, including human diseases.
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