Research Journal of Pharmacology and Pharmacodynamics

S. M. Patil ¹, A. P. Maske ², G. N. Sapkale ², A. B. Kure ²

Affiliations
1 ASPM's. K. T. Patil Collage of Pharmacy Osmanabad- 413 501 MS, IN
2 ASPM's. K. T.Patil Collage of Pharmacy Osmanabad- 413 501 MS, IN

Abstract

A Vaccine is a preparation, which is used to stimulate immune system, improves immunity to a particular disease. Vaccine can be prophylactic or therapeutic. Most vaccine registered for use is designed to prevent or control acute human infections. The conventional approaches to vaccine Research and Development are as Isolation and Characterization of disease causing organism, to discover methods to effectively immunize and protect susceptible host and to develop assay to measure immune response and identity immune correlates of protection, Manufacturing and Preclinical development, Clinical and Field testing in humans. New approaches to vaccine development are as use of anti-idiotype antibody preparation to mimic B-cells epitops, Synthesis of oligo or polypeptides that reflect naturally occurring a sequence of protein of pathogen. rDNA Transfection of cells with inserted DNA/CDNA into genome of other viruses and bacteria. New prophylactic and therapeutic vaccines will prevent and potentially cure disease. New delivery systems for human vaccines are being developed to enhance cellular and Mucosal immunity, as well as ease of use, advances in current vaccines such as conjugated pneumococcal vaccines for adults, nasal spray vaccines for Influenza and adult a cellular pertussis vaccine will provide an efficient way to of longlasting protective immunity. There is as of today no TH1 adjuvant efficient in humans. Such adjutants are needed to develop powerful therapeutic vaccines against cancer or chronic infectious diseases. New vaccine delivery technology will provide easier delivery routs such as transcutaneous, depot, nasal, and oral delivery without compromising efficacy.

Keywords

Vaccines, Development, Delivery, Approaches.

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S. M. Patil ¹, G. N. Sapkale ¹, P. B. Kumbhar ¹, A. P. Maske ¹

Affiliations
1 ASPM's. K. T. Patil College of Pharmacy Osmanabad-413 501(MS), IN

Abstract

Clinical research is a systemic study of the drug biologic or device on human subject.

Any investigation in human s meant to determine the clinical, pharmacological pharmacokinetic, pharmacodynamic, and or risk/benefits properties of a drug device or biologic. There are four phases in clinical trials. Need of quality assurance in clinical trial is for building quality in upfront assuring quality through the process. As in clinical trial we are dealing with a human life and every thing is for patient safety. When drug development reaches the stage where the drug product are produced for clinical trials in human, then compliance with the cGMP regulation is required. The drug product must be produced in a qualified facility, using laboratory and other equipments that have been validated. Operating under a State of Control produces drug products for which there is adequate level of assurance Quality, Strength, Identity and Purity The manufacturer is responsible for the quality of the Pharmaceutical product at batch release by applying GMP During manufacturing, packaging, QC testing. The product should be stable throughout the shelf-life Quality assurance for the product should be Monitoring environmental conditions under which products are manufactured/stored, air and water systems to prevent contamination, Monitoring of personnel QA at Clinical Site to Supervise, Maintain Records, Adhere to Protocol, Learn investigator procedures, Report Adverse effect, Retain Records and Train Staff.

Keywords

Clinical Research, Quality Assurance, Pharmacodynamic, cGMP.

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