Statistical Issues in Drug Development Second 2nd Edition Book

EBook Description: Drug development is the process not only of finding and producing therapeutically useful pharmaceuticals and of turning them into high-quality formulations of usable, effective and safe medicines, but also of delivering valuable, reliable and trustworthy information about appropriate doses and dosing intervals and about likely effects and side-effects of these treatments. Drug development is a process carried out by sponsors (mainly pharmaceutical companies) and its acceptability is ultimately judged by regulators. It is an extremely complex business and the risks are high, but the potential rewards are also considerable.

Despite the dominance of animal cell culture in the production of biopharmaceuticals in recent times, this technology was not consolidated into standardized large-scale bioprocesses until the 1990s. Nevertheless, the first experience with animal cell culture can be traced back to the beginning of the 20th century. By the use of the hanging drop technique and frog heart lymph, Ross Harrison, at Yale, tried between 1906 and 1910 to elucidate how the nervous fiber is originated (Witkowski, 1979). He considered three hypotheses: (i) in situ formation from the nerve sheath; (ii) preformed protoplasmic bridges; or (iii) as a result of the nerve cell growth itself. When Harrison demonstrated the validity of the third hypothesis, he also confirmed the cell as the primary developing unit of multicellular organisms.

Computational Pharmacokinetics Book

When you take a drug, you do that because you want an effect � reduced headache, relief from an asthma attack, lower blood pressure, or something else. When you swallow a tablet, the substance in it is absorbed and distributed in the body, before being metabolized and/or eliminated. The science that deals with this is pharmacokinetics, abbreviated PK. It involves a modelling part in which data obtained from clinical studies are used to describe how the drug is handled by and distributed in the body. Clinical pharmacokinetics is the bedside application of this information, assuring that the drug is appropriately used in the treatment of a medical condition.

Nanoparticulate Drug Delivery Systems DRUGS AND THE PHARMACEUTICAL SCIENCES Book

Nanotechnology and nanoscience are widely seen as having a great potential to bring benefits to many areas of research and applications. It is attracting increasing investments from governments and private sector businesses in many parts of the world. Concurrently, the application of nanoscience is raising new challenges in the safety, regulatory, and ethical domains that will require extensive debates on all levels.

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