The goal of each pharmaceutical company is to develop drug product and get marketing authorization approval. It changes the life of the patients by giving better life. When a company is planning a drug development journey it should have clear thoughts how new product will improve the patient’s life compare to available products in the market or in the pipeline. A Target Product Profile (TPP) is very helpful assistance in recognizing the chosen product characteristics and interactive them to the drug progress team, stakeholders, and regulatory establishments. The drug development process is very lengthy and expensive .TTP facilitates the complicated path which ending with FDA approval by proving all drug related scientific and medical information.
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Safety and effectiveness of Rituximab not studied yet in children so contra indication in this age group.
Clinical Pharmacology
Clinical Studies showed that rituximab inhibits with the interior functional B-cells and inducing apoptosis (cell loss) by intrusive with CD20 calcium level and uplifting the level of calcium in the B-cells from usual to unusual levels.
There are three chief mechanisms through rituximab acts in the body. One process by which the B-cell is demolished by direct ingestion of the B-cell by the effector cell in a development called antibody-dependent phagocytosis but this play very little part in B-cell demolition. A second and very significant process studied that antibody-dependent cellular cytotoxicity (ADCC) where undamaged B-cell is not swallowed or phagocytized but definite effector cells or destroyer cells are activated to discharge pore creating proteins which enter to the B-cell tissue and same time proteolytic enzymes which destruct its arrangement and destroy its genetic material called cell …show more content…
Rituximab, an anti-CD20 mAb has introduced in the market more than a decade intended for the treatment of many B-cell sicknesses. The Hatch-Waxman Act encourages generic competition (Biosimilar) to make available biologic for larger population by reducing drug cost. Biologics product can obtain patent protection lasting for 20 years from the date the patent application, so hard to make biosimilar. In year the 2006 the EU has approved the first Biosimilar while in 2009, the Biological Price Competition and Innovation Act (BCPI) was created for Biosimilars and signed into law on March 23, 2010 through The Patient Protection and Affordable Care Act (Affordable Care
Safety and effectiveness of Rituximab not studied yet in children so contra indication in this age group.
Clinical Pharmacology
Clinical Studies showed that rituximab inhibits with the interior functional B-cells and inducing apoptosis (cell loss) by intrusive with CD20 calcium level and uplifting the level of calcium in the B-cells from usual to unusual levels.
There are three chief mechanisms through rituximab acts in the body. One process by which the B-cell is demolished by direct ingestion of the B-cell by the effector cell in a development called antibody-dependent phagocytosis but this play very little part in B-cell demolition. A second and very significant process studied that antibody-dependent cellular cytotoxicity (ADCC) where undamaged B-cell is not swallowed or phagocytized but definite effector cells or destroyer cells are activated to discharge pore creating proteins which enter to the B-cell tissue and same time proteolytic enzymes which destruct its arrangement and destroy its genetic material called cell …show more content…
Rituximab, an anti-CD20 mAb has introduced in the market more than a decade intended for the treatment of many B-cell sicknesses. The Hatch-Waxman Act encourages generic competition (Biosimilar) to make available biologic for larger population by reducing drug cost. Biologics product can obtain patent protection lasting for 20 years from the date the patent application, so hard to make biosimilar. In year the 2006 the EU has approved the first Biosimilar while in 2009, the Biological Price Competition and Innovation Act (BCPI) was created for Biosimilars and signed into law on March 23, 2010 through The Patient Protection and Affordable Care Act (Affordable Care