Angie's Final Paper

Doctors do a lot of testing on medicines and drugs before they are ever allowed to be used in a store or on a patient. The first stage in this process is called the pre-clinical research. In this stage the drug is tested in animals to see how they react and if it is deadly or not. These studies can take anywhere from one to three years to make sure they are safe to be tested on humans. Once they have made it through all the animal testing then it must also go through a series of clinical test in humans. There are four stages that the drug must go through ranging from small scale to assess safety and then the tests get larger and more complex to test efficacy.
Phase one involves testing the drug on a limited number of healthy individuals to determine the drug’s basic safety and pharmacological data. They usually use about twenty to eight patients for these tests and these tests usually last six months to a year. The second phase involves a slightly larger number of patients anywhere from 100 to 200 patients. These patients have suffered from targeted diseases or conditions, to determine how the drugs effectively work on them and the dose amount needed this stage of tests last anywhere from one to two years to perform. The third phase is divided into two parts, part A involves testing the drug on anywhere from hundreds to thousands of patients to verify efficacy on a large scale as well as safety. This phases focuses on regulatory approval issues and are usually done in many different places and are usually two to three years long. After this is complete then they are allowed to submit a registration label for the drug containing all the pre-clinical, pharmacologic, efficacy and safety data; also the sponsor’s plans for producing and packaging of the drug. This review can take up to thirty months or longer, depending on the country, type of drug and some other minor factors. The fourth and final phase of this process begins after regulatory approval and typically is used to prove safety and efficacy in new indications to test things such as new dosage strengths and formulations. It’s also to confirm certain extra clinical benefits such as cost-effectiveness or improved quality of life; and to collect and analyze long-term safety data on patients treated with the drug in normal practice.
After running these tests on the healthy male they can suspect the medicine is going to work efficiently on the sick patients. But with studies being more advanced, more studies not only need to be done on healthy males, but also on healthy females for many reasons. When one is a child, either male or female, their bodies are almost the same in strength, aerobic power, heart size, and weight. But while undergoing puberty the female body changes due to the influence of the female sex hormones, which affect bone mass, lean body mass, circulation, and metabolism. (The female athlete) The typical women’s body is portrayed with a wide pelvis, femoral anteversion (which is the inward twisting of the thigh bone), genu valgum (also known as knock knees, where the knees are closer together and tend to even touch when standing up straight), and external tibial torsion (which is where the tibia bones either rotates inward or outward causing the lower leg to also rotate). There not are only a lot of changes in women during puberty but also in males. Males tend to gain muscle mass and lose body fat under the influence of androgens, while girls now are gaining lean mass and fat mass. By the time of adult hood on average women have ten percent more body fat than men. Boys' metabolism tends to sky rocket during puberty whereas girls' slow down during this time in their life. The presence of estrogen and progesterone promotes greater reliance on fat metabolism at a given relative exercise intensity, enhances glycogen uptake and storage, and enhances glycogen utilization.
During puberty and even a little before is usually when boys and girls begin to be interested in sports. While being involved is very important they should know about the possible injuries and what may affect these injuries. One major component is muscle make up and muscle strength. Differences between girls and boys in muscle strength is not because of fiber type, but rather muscular hypertrophy and percentage of muscle mass. These numbers are greater for boys there for they are less likely to tear their ACL but does not mean they are in the clear by any means. Another major change when going through puberty is the body’s composition and circulatory parameters which causes a greater cardio-respiratory capacity in men. This in turn allows men to have a higher oxygen-carrying capacity relative to women. Since women have a lower amount of oxygen being distributed to the muscles they will be most likely become weak and injuries are more likely to occur. Every little component can play a role in how your body may react to a certain medicine or a certain healing process when dealing with recovery from injuries.
One main injury which not enough research has been done on women is a torn anterior cruciate ligament (ACL). A lot of research has been done and studies have shown being physically active is very important in helping prevent tearing a person’s ACL. While a torn ACL is a very common injury in any sport, girls should be a little better informed about this than boys due to the fact that they have an eight to two ratio and are more likely to tear their ACL in the same sports as boys do (Dwyer, 2001). This means for every sport males and females are involved in, for every two males that tear their ACL on average eight women will have torn their ACL. While the exact reasons for this is unsure they assume estrogen and genetic makeup plays a role in this (Coggin). Informing girls of this is very important before they get involved in sports. Not to try and scare them away from sports, but just so they know what can happen and they know what they can do to help prevent such an injury.
Over thirty thousand high school and collage girls will tear their ACL in sports in one year. This is much greater than that of boys in high school and college. Some reasons for the differences are the difference in conditioning, physical structure, and muscle make up between the boys and girls. Boys start out in sports much sooner than girls usually. They are also much more active generally as children. Growing up, boys are more physically in shape, and less accident prone than girls for this reason. Girls tend to have a lot less muscle tone then boys due to the fact guys are more likely to get involved in weight lifting and training than girls are.
Not only do these factors play a role but scientific studies have also show that the women’s menstrual cycle plays a role as well. The level of estrogen in a female’s body varies with what stage of their cycle they are in. Studies have shown that a much greater percent of the females had this injury about midcycle (ovulatory phase) when estrogen levels were at their highest. Estrogen is thought to play a role since it directly inhibits the growth of collagen fibers.
Another major role is the lack of condition in women compared to men. As women have improved their training and conditioning the injury rates have become more evenly distributed. Gender issues seem to play a role in this type of injury as well. Women do not have as much muscle protection around the knee, women’s hormonal effects on ligamentous tissue (laxity), and landing techniques. While this relating to the amount of estrogen is assumed and how it is on a rotation that can be monitored is still under studies.
Perimenopause, or menopause transition, is the stage of a woman’s life, starting as their thirties more commonly in their forties, when the ovaries gradually begin to produce less estrogen. Doctors use to just give women estrogen shots to try and balance what they were not producing but after extensive study they stopped this procedure. They then came up with an estrogen plus progestin compound to better suit their body and try and help prevent hip fractures and colon cancer. But after various studies and extensive studies the results showed that the risks much outweigh the benefits. This estrogen supplement can cause several problems such as gallbladder disease, diabetes, quality of life, and cognitive functions. The other alternative that is being considered is a placebo drug that the risks are much less. Compared to the estrogen plus progestin the estrogen patients experienced seven times more conoary heart disease events, eight more strokes, eight more pulemonary embolisms, eight more invasive breast cancers, 6 fewer colorectal cancers, and 5 fewer hip fractures. Combining all the monitored outcomes, women taking estrogen plus progestin might expect nineteen more events per year per ten thousand women than women taking placebo.
ACL injuries and estrogen debates are just a few of many injuries and conditions occurring in female which require some more studying. There are many roles that come into play such as body make up, body strength, body mass, how you take care of yourself, and so much more. More studies should be done on women to be able to better tell what women can do to prevent these occurrences. Also because of body make up medicines can also act differently in males and females so medicines should be tested on both female and male subjects before being used in everyday situations.

Unless otherwise stated, the content of this page is licensed under Creative Commons Attribution-ShareAlike 3.0 License