1Drug Development

English III
Instituto Politcnico Nacional
Unidad Profesional Interdisciplinaria de Ingeniera Campus
Guanajuato

Karina Ivette Gonzlez Flores

April 2015.
 Drug development

Introduction

After the long process involved in discovering a drug still there is a longest way

in order that the process is complete. The development implicates the safety, efficiency,

formulation and manufacture. The safety studies begin with the preclinical tests and when

they are approved, the tests are begun in human beings.

Development

The preclinical test are realized in a controlled manner, in these tests are used cell

cultures and animals like model. Models are used to predict their pharmacokinetics,

pharmacodynamics and the potential risks and side effects. When a drug approved the

preclinical tests, the scientists continue with the clinical tests.

Clinical tests are used to determine the safety, appropriate posology, effectiveness

and the effects of the long-term use; these tests are realized in humans according to

international standards.

Clinical tests are realized in in three successive phases, in each phase is evaluated

a major number of human beings. Each phase has a different purpose and, when a phase

is successful, the scientists continue with the next phase but if a phase is not successful,

the clinical tests are stopped. When a drug is approved, the tests continue to have a

monitoring safety and efficacy; this test is realized in a fourth phase.

Conclusion

The process to achieve to commercialize a medicament is very long, it takes

between 10 and 15 years in to complete the different stages and, the majority of the

medicines in investigation does not obtain it. This process is necessary because there is of

for way the life of the human beings; however, the process is very expensive