Question:
Describe about the Pharmaceutical Medicine?
The medicine is required for treating any patients suffering from illness and improving their health quality. The medicines are developed after thorough research by the physician or others with a view that medicines can be circulated to large areas and people can avail it for better health structure. This is a methodology to find out a solution of an illness by inventing new chemical moiety. Drug is a chemical substance which exert effects when binds with the receptor. Medicine is a chemical substance which binds with receptors and relieved humans from there changing physico-chemical conditions. The particular study will be focusing on having clear understanding of pharmaceutical medicine and its aims. Further, the study will concentrate on drug discovery process.
Pharmaceutical medicine is regarded as a medical scientific discipline which is involved in the discovery, development, evaluation and registration of medicines. On the other hand, it is also concerned with the monitoring and medical facets of marketing of drugs and medicine for the improvement in the health of patients or community health. Moreover, development of a new medicine and making the medicines available for the patients or public is an international endeavour. Further, it has been discussed that careers in the field of pharmaceutical medicine comprises three major groups of professionals such as:
Improving the health condition of the people is prime duty of the medical professionals or physician. Therefore, the major aim of the Pharmaceutical Medicine is to discover, develop, evaluate, analyse and monitor so that effective medicine can be developed and supplied to the people.
Integrated Drug Discovery and Development is a broad spectrum which concentrates on effective medicine development so that health status of the people can be enhanced and the developed medicine can target the specific disease and eliminate it. Therefore, drug discovery and development requires thorough research and study so that the medicines can provide long term benefit. Thus, the following requirements are needed for integrated drug discovery and development:
Methods of Drug Development: The total Drug Development Process is divided into some phases stated below.
Phases of Clinical Trials: There are mainly 4 phases and now a day’s another phase has been added. The Phases are respectively Phase 0, Phase 1, Phase 2, Phase 3 and Phase 4. In Phase 0, subjects should be 10 to 15 and a single sub healing micro dosing has been given to the subjects to gather preliminary ADME data. Phase 1 is a preliminary pharmacological activity screening phase where 70% drugs get approval to go to the next stage. Number of subjects taken are 20 to 80 with a 3 to 6 months duration. Phase 2 is the starting phase to check efficiency of the molecule with therapeutic dose reaction factors. 100 to 300 Patients are taken and the duration of the phase is up to 1 year. Phase 3 this is the final phase of a drug before pharmaceutical marketing and this is the phase where adverse drug effects has been checked and monitored also compare with current remedies and all the documents has been submitted to FDA for approval. Only 20% to 25% drugs are approved for phase 4 trial. The subjects needed for phase 3 is 1000 to 5000and the duration is for 1 to 5 years. Phase 4 is a post promotion phase where the effectiveness and ADR in general population has been observed and any kind of serious ADR leads to Drug Withdrawal from the market.
The main works of this trials are engage individual subjects and creates a organize group to conduct studies. Maintain the time is very important with proper monitoring on side effects of the chemical entity. Evaluation of the technical data is very important. Also the preparation of documents based on the guidelines of ethical committee is very important for approval.
Conclusion of the Study:
From the whole study, it can be concluded that the study revolved around the pharmaceutical medicine. The pharmaceutical medicine has been explained and its purpose has been mentioned which is useful in developing a new drugs or medicine. Therefore, it helps in providing large benefit to the patients or to the public health. Furthermore, the integrated drug discovery and development has been outlined which explains the different required which needed for drug or medicine development. This is the study which helps to conclude that the newer chemical entity is ethically sounded and this will help humans to get rid of from a disease.
References
1. Mumper R, Smith C, O’Donnell J. The Process of New Drug Discovery and Development, 2nd Edition. Drug Development and Industrial Pharmacy. 2008;34(11):1267-1267.
2. Physico-Chemical Methods in Drug Discovery and Development. Chemistry International — Newsmagazine for IUPAC. 2012;34(3).
3. Lin B, Pease J. A Novel Method for High Throughput Lipophilicity Determination by Microscale Shake Flask and Liquid Chromatography Tandem Mass Spectrometry. Combinatorial Chemistry & High Throughput Screening. 2013;16(10):817-825.
4. Developing new drugs. Veterinary Record. 2014;174(20):488-488.
5. Scheele. AMT: Preclinical pharmacology studies. International Journal of Oncology. 2009;.
6. Chakraborty S, Yadav L, Aggarwal D. Prediction of in vivo drug performance using in vitro dissolution coupled with STELLA: a study with selected drug products. Drug Development and Industrial Pharmacy. 2014;:1-7.
7. Sedgwick P. Phases of clinical trials. BMJ. 2011;343(sep28 1):d6068-d6068.
8. Williamson P, Altman D, Blazeby J, Clarke M, Devane D, Gargon E et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132.
9. RASMUSSEN L, GISVOLD S, WISBORG T. Ethics Committee approval for observational studies. Acta Anaesthesiologica Scandinavica. 2014;58(9):1047-1048.
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