PHARMACEUTICAL INDUSTRY:

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.

DRUG: Drugs are substances (other than devices) used to diagnose, prevent, cure, or relieve the symptoms of disease.

ROLE OF DIFFERENT SCIENCES IN PHARMACEUTICAL INDUSTRY:

1)PHARMACY: DEFINITION:
Pharmacy (from the GREEK 'pharmakon' = drug) is the health profession that links the health sciences with the chemical sciences, and it is charged with ensuring the safe and effective use of medication.

PHARMACISTS:
If you ask most people to tell you what a pharmacists does, they will likely tell you that a pharmacist spends most of his or her day counting and dispensing medications in a little room at the local drug store. While this may have been true at various times and to various extents over the last hundred years, the duties of today's pharmacist are decidedly more complex. According to American Pharmaceutical Association. "The major reason is that today, drug therapy is far more complex and comprehensive and challenging to use. We use it far more aggressively and we use it far more often. It has become a primary form of treatment. Where in the past, hospitalization and surgery were more the primary forms of treatment, today it's drug therapy."

 ROLE IN INDUSTRIAL PHARMACY: Statutory provisions in some countries may require that certain positions be held by pharmacists. The main activities of industrial pharmacists are described below: Research and development:

Pharmacists contribute to research, and their expertise in formulation development is of particular relevance to the biological availability of active ingredients. Manufacture and quality assurance:

The pharmacist's broad knowledge of the pharmaceutical sciences ensures an integrated approach to quality assurance (including good manufacturing practice) through the validation of the various stages of production and the testing of products before release. Drug information:

The pharmacist has the knowledge and expertise to provide detailed information on medicines to members of the health professions and the public. Also, pharmacists provide an information service within the company. Patent applications and drug registration:

The pharmacist is ideally qualified to understand and collate the diverse information required for patent and authorization submissions. Clinical trials and post-marketing surveillance:

The pharmacist has the knowledge of drugs and health care provision required to facilitate collaboration between companies, health professionals and governments in relation to clinical trials and surveillance. Sales and marketing:

The pharmacist, whose professional ethics demand a concern for the interest of patients, can make a contribution to proper

marketing practices related to health care and to the provision of appropriate information to health professionals and the public. Management:

The inclusion of pharmacists in all levels of management promotes an ethical approach within management policies.

2)STATISTICS: DEFINITION:
The word statistics can either be singular or plural. In its singular form, statistics refers to the mathematical science or refers to a quantity (such as a mean) calculated from a set of data.

STATISTICIAN:
Statisticians in the Pharmaceutical Industry, abbreviated to PSI, is an organisation for the promotion of statistical thinking in order to improve the quality of research and development in the pharmaceutical industry. PSI achieves its vision by providing a forum for regular discussion of statistics and matters relating to the practice of statistics in the pharmaceutical industry, as well as promoting good statistical practice within the industry. ROLE IN INDUSTRIAL PHARMACY: The pharmaceutical statistician contributes to all stages of the drug development process. A statistician in the pharmaceutical industry works closely with data management staff, programmers, clinical researchers and investigators. When working for a CRO, there are also interactions with clients.However, the greatest involvement is in the four phases of clinical development Clinical development plan Study design, Analysis and Presentation of results. The Clinical Development Plan : Before the clinical phase begins, the statistician is aware of

the pre-clinical analyses concerning the compound, together with the results of any other previous relevant trials and any safety or efficacy issues that may have an impact on clinical development. The statistician seeks to improve his or her understanding of the natural history of the disease/disorder/problem concerned, and literature searches are performed to identify suitable efficacy variables and the magnitude of clinically relevant effects.

Clinical Study Design :

The statistician provides advice on the total number of subjects required for efficacy and safety evaluation. This is accomplished by advising on the appropriate set of trials to be included in the clinical development plan and estimating the subject numbers required for each trial. The aim is to optimise the development process - this means exposing the minimum number of patients to trial therapy and conducting the minimum number of trials required to support registration for a product licence. The statistician assists in planning the timings and sequence of trials, the flow of data and the required resources. The dates and requirements for product licence applications and publication strategy are discussed within the development team.

Analysis and Presentation of Results: The statistician is responsible for programming, data analysis and generation of the statistical report, which provides a detailed description of the results of the clinical trial and the statistical interpretation of those results. The results of the analyses are discussed with the clinical research staff and investigators. The statistician is involved in the preparation of the dossier for submission to regulatory authorities and responds to questions from regulatory authorities. Data from studies of a similar nature, for a drug already approved by the regulatory authorities, may be combined and analysed by the statistician and, after discussions with

clinical research staff and investigators, the results may be incorporated into publications.

3)BIO-CHEMISTRY: DEFINITION:
Biochemistry is the 'Chemistry of Life'.Biochemistry is the study of the chemical processes in living organisms. It deals with the structure and function of cellular components such as proteins, carbohydrates, lipids, nucliec acid and other biomolecules.

BIOCHEMIST:
It is central to all areas of the Biological or Life Sciences. The aim is to provide an understanding of every aspect of the structure and function of living things at the molecular level.Biochemists work at all levels and with all types of biological organisms, ranging from biomolecules to man. There are close links with other specialist life sciences, such as Cell Biology, Genetics, Microbiology, Molecular Biology, Physiology and Pharmacology. ROLE IN INDUSTRIAL PHARMACY: It is stated that the great importance of the various disciplines of biochemistry, including patho-biochemistry and pharmacological biochemistry, is presently recognized, and the involvement of biochemistry in drug research is increasing. Clinical Biochemist:

Clinical biochemists work in pharmaceutical companies, researching the medical implications of different drugs and chemicals in humans. Biochemists, perform experiments to detect the presence of viruses, bacteria, or irregular or maladaptive substances. Study Of Chemical Structures Of Healthy and Diseased Tissue Samples :

A clinical biochemist who works in the biotechnology or pharmaceutical industry closely studies the chemical structures of healthy and diseased tissue samples from living things. He or she may try to understand the composition of a new or rare strain of disease, in order to develop effective medications or vaccinations against it.

The Clinical Trial:

A clinical biochemist may also oversee research studies and clinical trails of new medications. He or she is responsible for ensuring that the drug is effective and safe for humans before it can be mass marketed.

4)CHEMISTRY: DEFINITION:
Chemistry (from Egyptian kme (chem), meaning"earth") is the science concerned with the composition, structure, and properties of matter, as well as the changes it undergoes during chemical reactions.

CHEMIST:
A chemist studies matter on the atomic and molecular levels in order to understand how elements join together to form different substances. A chemist also measures proportions, reaction rates, and various other properties of substances in order to understand more about those substances. ROLE IN INDUSTRIAL PHARMACY: MEDICINAL CHEMIST:

The medicinal or discovery chemists identify the new drug candidates to treat or prevent a particular medical indication, whereas the process chemists are responsible for devising a synthesis and supplying the active pharmaceutical ingredient (API) or bulk drug substance (BDS) in multigram quantities for various studies needed to file the IND and support other drug development programs. On approval of the IND, the compound can be administered to humans for the first time as part of the phase-I clinical studies, also known as first-in-man (FIM) trials. Studies that are reported in an IND include synthesis, animal toxicology, pharmaceutics and formulation, drug substance and drug product stability and safety, and metabolic and pharmacokinetics. ANALYTICAL CHEMIST:

Analytical chemistry underpins pharmaceutical drug development by providing assurance of the quality, safety and efficacy of new medicines. This course is an overview of the areas in which analytical

chemistry plays a vital role in developing a new drug. There is a focus on HPLC as being the most important analytical procedure in todays pharmaceutical industry, but other techniques are also covered, for instance those used to investigate polymorphism in new drugs.

5)PHYSIOLOGY: DEFINITION:
Physiology (from Greek , physis, "nature, origin"; and -, -logia) is the study of the mechanical, physical, and biochemical functions of living orgnism. PHYSICIAN: A role for the pharmaceutical industry in medical education point to the potential benefits of collaborating with physicians in industry, for example, improved clinical trials and access to role models. In fact, most physicians working in industry began their careers in academia, which is ideal for trainees wishing to learn about the conduct of clinical trials and pharmaceutical medicine as a career pathway. Residents require detailed information on how pharmaceutical companies function, but they rarely receive it during training. ROLE IN INDUSTRIAL PHARMACY: The pharmaceutical physician was essentially involved in training of representatives and supporting marketing claims. However, in recent years industry focus has moved to research and development, international alliances and globally acceptable clinical research. CLINIAL RESEARCH:

The clinical research physician's role is to act as the scientific expert to support clinical development of a new product.He has to prepare a clinical development program, which is compliant with the current applicable regulatory and ethical guidelines and which is supportive of the commercial goals of the company. Physicians often need to prescribe medications to achieve desired therapeutic goals for their patients;industry often generates researchbased medications to improve treatment;industry views physicians as the rate-limiting step in the prescription of their medications; and industry, primus interpares, must profit to survive establish the potential for both confluence and conflict of interest.