given i ntravenously. Then the chances of getting treatment mean sum of squares being bigger than the error mean sum of squares are more in design 2 compared to design 1. By making research easy to access, and puts the academic needs of the researchers before the business interests of publishers.We are a community of more than 103,000 authors and editors from 3,291 institutions spanning 160 countries, including Nobel Prize winners and some of the world’s most-cited researchers. bioavailability indicating the importance of the correct cosolvent. So, the bioavailability and bioequivalence studies carried under stringent protocols and modified according to the needs. Available from: In initial study, it is acceptable to replace a subject withdrawal or dropout once it has provided the substituted subject follows the same protocol originally intended for the withdrawn subject and subject is tested under similar conditions. J. It has been proved beyond doubt that most of the times intersubject variation is greater than the variation between any formulation. 877-886.Coleman, G.L., Magnus, A.D., Haigh, J.M., Kanfer, I: It is mainly due to increasing the number of generic drugs and its formulations and marketed after regulatory acceptance. Generally, these tests measure the difference in the non-immunological inflammatory response to an exogenous inflammatory mediator in the presence and absence of the corticosteroid under test. The absolute bioavailability of new drug is used to assess the pharmacokinetic parameters of an oral formulation relative to that of an intravenous dose or performance of a modified release formulation in comparison to a conventional capsule. This chapter is distributed under the terms of the Help us write another book on this subject and reach those readersLogin to your personal dashboard for more detailed statistics on your publications.We are IntechOpen, the world's leading publisher of Open Access books. Information about bioavailability of new drug formulation is obtained by comparing the pharmacokinetics parameters of an intravenous and oral administration of new drug formulations having the same dose [When a manufacturer wishes to gain therapeutic equivalence for introducing a competitive generic product into the market place, it is not necessary to conduct the full batch of clinical trials needed for the first product. Bioequivalence studies are not required for when the test drug is in the form of solution for oral use and contains the drug in the same dose and does not contain an excipient that is known to affect gastro-intestinal absorption of the drug; when the test drug is in the form of an ophthalmic or topical product prepared as aqueous solution and contains the same active ingredients in the same concentrations and essentially the same excipients in comparable concentrations when the test drug is in the form of powder for reconstitution as a solution and the solution meets either above second and third points, when a test drug is in the form of an inhalation or a nasal spray tested by administered with or without the same device used for reference drug.The object of the bioavailability study decides the study protocol. A study protocol used for estimating pharmacokinetic parameters is different from a bioequivalence study carried out for comparing the test formulation with standard formulation.The main object of the experimental design is to minimize the experimental variables and to avoid a bias [The nature of the reference drug and the dosage form to be testedBenefit risk ratio considerations in regard to testing in humansBioavailability studies are influenced by various factors such as age, sex, disease state, food habits, physical and mental health condition, body weight human volunteer, experimental design, time of administration, time of sampling, analytical method used and compartment model used in estimating pharmacokinetic parameters or bioavailability that contribute to the observed blood concentration time profile. The parameters TUrinary excretion method is based on the general observation that the rate of urinary excretion of a drug is directly proportional to the concentration of the drug in the blood. The carryover effects or dropouts were less in parallel studies compared to crossover studies.In crossover design, the treatments are compared on the same human subject, and the intersubject variability is reduced.