Pediatric Otitis Media
Introduction
Otitis media is an infection in the ear that it is caused by bacteria and viruses (MedlinePlus). Otitis media affects mostly children. Given to the high prevalence of the infection, Lacrialgia was created. Lacrialgia is the new drug that eliminates bacteria that is caused by otitis media. Lacrialgia is -cidal because it treats infections. It is used in combination with other drugs to treat certain types of infections more effectively.It is recommended for children that have had otitis media before. Specially, children that are under the age of two.
Delivery Route of Agent
Lacrialgia comes in a powder formulation to take it by mouth every 4 hours or as directed by a physician. The formulation of Lacrialgia …show more content…
According to the FDA website, the first step is discovery and development. During this step, it is important to note the symptoms of otitis media in children, so it could be created a new drug with the best benefits to treat those symptoms (1). The second step, is preclinical research. During this process, it is used the in vivo preclinical test. Therefore, the animals that are used to test Lacrialgia are pigs (1). The third step, is clinical research (1). During this phase the drug is tested in humans. This step is divided in 4 stages …show more content…
During the first stage, “20 to 100 healthy volunteers with the disease/ condition” are given a drug (lacrialgia)and it can take “several months” to determine whether the drug advance to the second stage (2). The purpose of the second stage is, “efficacy and side effects” (2). During this stage, Lacrialgia was tested in several people with the condition (2). This stage can take “several months to 2 years” (2). The purpose of the third stage is to test lacrialgia for “efficacy and monitoring of adverse reactions” (3). During this stage, “300 to 3,000 volunteers who have the disease” are tested. This process can take “1 to 4 years” (3). Finally, the purpose of the fourth stage, is “safety and efficacy” (4). During this process “several thousand volunteers who have the disease/ condition are tested”
Introduction
Otitis media is an infection in the ear that it is caused by bacteria and viruses (MedlinePlus). Otitis media affects mostly children. Given to the high prevalence of the infection, Lacrialgia was created. Lacrialgia is the new drug that eliminates bacteria that is caused by otitis media. Lacrialgia is -cidal because it treats infections. It is used in combination with other drugs to treat certain types of infections more effectively.It is recommended for children that have had otitis media before. Specially, children that are under the age of two.
Delivery Route of Agent
Lacrialgia comes in a powder formulation to take it by mouth every 4 hours or as directed by a physician. The formulation of Lacrialgia …show more content…
According to the FDA website, the first step is discovery and development. During this step, it is important to note the symptoms of otitis media in children, so it could be created a new drug with the best benefits to treat those symptoms (1). The second step, is preclinical research. During this process, it is used the in vivo preclinical test. Therefore, the animals that are used to test Lacrialgia are pigs (1). The third step, is clinical research (1). During this phase the drug is tested in humans. This step is divided in 4 stages …show more content…
During the first stage, “20 to 100 healthy volunteers with the disease/ condition” are given a drug (lacrialgia)and it can take “several months” to determine whether the drug advance to the second stage (2). The purpose of the second stage is, “efficacy and side effects” (2). During this stage, Lacrialgia was tested in several people with the condition (2). This stage can take “several months to 2 years” (2). The purpose of the third stage is to test lacrialgia for “efficacy and monitoring of adverse reactions” (3). During this stage, “300 to 3,000 volunteers who have the disease” are tested. This process can take “1 to 4 years” (3). Finally, the purpose of the fourth stage, is “safety and efficacy” (4). During this process “several thousand volunteers who have the disease/ condition are tested”