Understanding Pharmaceutical Medicine And Drug Discovery Process

Pharmaceutical Medicine

The Aim of Pharmaceutical Medicine

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:

• The people that are working in pharmaceutical industries
• People that are working in independent research organisations and are dedicated towards the development of new drugs or medicines.
• The people that has an appointments within the regulatory agencies of medicine.

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:

• Critical Chemical or structural research comprises exploration of genetic basis of syndrome or microstructure of an enzyme site or a receptor. Moreover, it is concerned in the development of tailored molecules so that potential therapeutic outcomes or specific interactions can be provided.
• Further, the research and development of preclinical engaged in studying the causes behind the diseases and also the value of the new therapeutic agents and potential safety by implementing biological system involving animal model.
• In the next part, humans are used for the purpose of clinical development. Therefore, in such case both type of humans are involved a healthy one and a person having disease in order to evaluate the safety and effectiveness of new drug.
• On the other hand, the regulatory and societal development makes sure that whole development of the new drug matches with the need in order to meet with the requirements of government. Moreover, the development ensures that suitable value added elements over and above the normal figure of safety and effectives are incorporated into the database of the product. The elements can comprise cost benefit, life quality, relative competitive positioning and evidence based medicine.
• Lastly, the approval of post market medical affairs include the promotion of every product by adopting functions of marketing and sales and effective monitoring of process by pharmaceutical physicians.

Methods of Drug Development: The total Drug Development Process is divided into some phases stated below.

• Target Selection – This is a process where the ailment has been identified and then a replica has been developed. Investigator first chooses a target which may be a particular enzyme or a receptor or an ion channel which is suitable to treat the disease.

• Target Validation – In this phase the importance of the new moiety has been established for that particular illness.

• Lead Selection – This is a stage where the thousand of chemical moieties are undergoes High Throughput Screening (HTS). From thousand of options the best receptor specific molecules are selected. HTS is a 40 years old lead selection instrument. It’s having highly assessment power which easily judged the binding and non binding capacity of a lead. Ultimately the leads have been sorted out and they are known as Hits. HTS helps to estimate the chemical, biological and physical properties of the Hits.

• Drug Optimization – Hits are chemically customized and the best suitable options are then pharmacologically distinguished. This helps to find the chemical moiety with appropriate pharmacodynamic as well as pharmacokinetic property.

• Pre Clinical testing – This is an assay procedure where biochemicals as well as pharmacological parameters are checked. Both in vitro (outside the living being) and in vivo (Inside the living being) methods are used to assay the leads and which will leads to find out the proper chemical moiety. Toxic effects and adverse drug reaction is also measured in this phase because this is the last phase of a drug development before trying in human beings.

• Clinical Trials – This is a phase where the drugs are given to the human beings and measure the safety and efficacy profile of the newer drugs. Evaluation of the potentiality of the newer drug in humans has been made through clinical trials. The total procedure has been conducted in 4 phases and now another phase (Phase 0) has been added. Every phase has their own significance and own outcomes. Depending upon the outcomes of the phases a drug or medicine has been approved by FDA (Food and Drug Administration).

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.

• Core works of Clinical Trials:

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.

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