logo
logo
Sign in

Preclinical Formulation Development

avatar
Tony Stark

Preclinical Formulation Developmentdeals with the process of formulating food products, which is done in a pharmaceutical context. It involves the use of various techniques and substances for the purpose of development of drugs for the treatment of humans and animals. It is mainly concerned with the aspects such as the effect of formulating chemicals in controlled environments. It involves the development of novel chemical entities for the manufacturing of medicine, energy or food. It also involves the study of the effects of novel forms of exposures on humans and their health.

It is one of the most important areas of pharmaceutical research. Most drugs that we take in the market are formed through preclinical formulation development. Many new drugs get introduced into the market without having undergone any formulation development. Such products may have some of the ingredients of other existing medicines or may not be safe enough for human consumption. Hence, pharmaceutical engineers must conduct an in-depth analysis before deciding to introduce any new drug in the market.

Preclinical development plays an important role in the development of essential medicines for the benefit of the patients. It helps in determining the toxicity of a product and the level of risk of exposure to it. This is done by the use of various procedures and tests in various parts of the world including the United States of America. The main purpose of the in-plant testing is to determine the level of toxicity of a product before it gets introduced in the market. However, the field of preclinical development goes beyond this.

Preclinical development involves the process of animal testing and evaluation before a new formulation is released for the patients. The animal testing is done using cells, tissues and organs in very sensitive stages. In the process of cell culture, many harmful substances are released in the laboratory. Hence, the development process must be very careful and must be monitored often to ensure no side effects occur in human beings. The cell culture process also involves various regulatory agencies and should be approved by them.

In addition, the nutritional supplements are also a part of this process. Formulation development process also involves the development of the manufacturing standards and GMP. Such rigorous procedures must be followed to ensure the products contain no residues or allergens.

Formulation development companies also test the products, once the development process has been completed. They also look into the claims by the company in respect to the safety and efficacy of the product. The company's report must be thoroughly checked by other independent parties. This helps in establishing whether the product is reliable and effective.

The preclinical or the early development phase is critical for a number of reasons. First, it allows testing on new formulations that might not have been tested in the animal models. This might also allow better identification of allergens in human products. Such development might also lead to the discovery of effective methods of reducing costs and improving service delivery and quality.

Preclinical activities must be performed according to strict guidelines and comply with all standards set by regulatory agencies. Formulation companies must work in close association with regulatory agencies and perform all the activities in accordance with the stipulated regulations. All the development activity must be conducted in facilities approved by the regulatory bodies. The facilities must be established to ensure controlled and well controlled exposure of the end users and to ensure clean handling and data collection as well. The preclinical activities must also be monitored periodically by independent auditors to ensure compliance with the policies and procedures laid down by the regulatory bodies.

collect
0
avatar
Tony Stark
guide
Zupyak is the world’s largest content marketing community, with over 400 000 members and 3 million articles. Explore and get your content discovered.
Read more