Importance of Bio Equivalence Studies

Byerly, W. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy: AJHP: Official Journal Of The American Society Of Health System Pharmacists, 66(2), 176-184. Retrieved from http://library.kaplan.edu/content.php?pid=150035

Biotech companies’ values are primarily driven by intellectual property, they do not need to rely much on their suppliers. These companies also have relatively easy access to sources of raw materials (such as chemicals), scientific tools, computers and testing equipment.

There are several types of medication, each has a purpose and function needed for their administration via the different routes.

Right Outcome: it is important that the medicine achieves the right outcome that of improving someone’s condition.

1. first by the conditions that they are used to treat, and then by their mechanisms of action

Medication has also become increasingly complex. There has been a massive increase in the number and variety of medications available. In addition, many medications have different routes of delivery, variable actions (long acting, short

Pharmacokinetics "is the way a drug is absorbed, distribution, metabolism, and excretion (pg. 749 Treas)

E. Generic drugs can have different manufacturers, which mean they can also have different inactive ingredients in it.

There are several rewards to consider with expansion of Biocon. Currently in India, there is a growing market for contract research organization and the growth of Biocon falls right within this opportunity. The growth is expected to last for more than few years with a rate that looks promising. Clinigene is expected to reap revenues much higher than the current Biocon and Syngene combined (Kalegaonkar A., Nov 4, 2008). It will take clinical studies to a higher level with better options in terms of drug manufacturing. With other countries ready to outsource the service of clinical studies, Clinigene’s future looks bright.

Several epidemiological and survey research has reported that gender does affect the perception and amount of pain perceived after a procedure. A greater frequencies of pain related symptoms among females than males have been reported in the general population (Unruh_1996; Woodrow_1972; Robinson_2004). A number of explanations for the sex differences in pain responding are offered. For Fillingim (2000), this overrepresentation of women in several pain condition cannot be explained by the greater tendency among females to seek treatment, thus females appear to be at increased risk for experiencing pain-related symptoms . Biologic differences between men and women, such as hormonal differences, and nervous system organizational differences were

Both medications are indicated for hypercholesterolemia or mixed dyslipidemia, but they differ in solubility due to chemical structure and other reasons explained below.

Education is now the order of the day. Many people aim at continuing their education after high school. After high school, some students enter directly to college whiles others go to universities to read different course of their choice. Among these courses, some prefer to read mathematics, literature, science, economics, and others. Every student has his / her own career path in life. Some aim at becoming Biologist whiles others aim to be a Chemist. This is basically for students who have interest in the science field determines which areas they want to study. When it comes to the issue of Chemistry and Biology which one to be chosen from, here lies the individual own preferences. Biology and Chemistry have similarities in science, whereas they have their differences and their branches. Chemistry and Biology are related courses so those who are interested in science-related programs as their career can go for it. The systematic study of all the matter that exists is science involves both observations and experiments. There are different matters also exist in the universe. The study of a living organism is Biology. Biology is divided into various branches such as Zoology, Botany, Taxonomy etc, whereas, Chemistry can be defined as the branch of science that deals with matter, its composition , reactions, structures, and properties. Both Biology and Chemistry plays an

- The biotech industry is a very uncertain environment top operate in. Giving a quantative planning can create a false sense of accuracy. That way a planning can lose much of it’s added value and confidence in planning might even disappear altogether. Strong points in Amgen’s planning is that the company focuses mainly on qualitative aspects. It should be remarked however that Amgen is in the luxurious situation that because of two very successful products she is not (totally) dependent on external investments.

Pharmaceutical sciences combine a broad range of scientific rules that are critical to the discovery and development of new therapies and drugs, and so in that saying, knowing this kind of information can help people around the world greatly in the future.

activities and tactics such as sampling and sales force promotion [3]. Whether a brand manager is using right promotional tools, whether 4P`s (now 7P`s are considered) are linked to each other and with product strategies for the two main objectives that includes [3]:  To Generate Prescription  Make the product reach the patient They can be said as Product chain and Prescription chain 1.1 The Product Chin This starts from selection of molecules and ends in the hands of patient. This chain is somehow intensive as it starts from the selection of molecules, then molecules are critically screened, after the screening of molecules the source of raw material is identified then the pilot batch manufacturing process starts at this stage pricing strategies and clinical trials are worked out. Once the pilot batch is manufactured then it starts with the commercialization of product, after commercialization product goes to distribution house and then it reaches the retailers. After patient’s diagnosis by doctor, patient purchases that product from retailer [4]. 1.2