Preclinical phase

There is increasing pressure to develop homochiral dmgs (34). Growing demands are faced by the pharmaceutical industry in dmg development to consider chiral issues in the eady preclinical phases of dmg design and synthesis. 

When a pharmaceutical is in the early stages of drug development (e.g., preclinical phases), the amount of material is limited and little is known about the characteristics of the molecule. Thus, CE is an attractive technique for developmental work due to its low sample consumption. Multiple injections can be made from a few microliters of sample, thus allowing optimization and early qualification of methods. 

Preclinical—phase II Formulation design Process scale-up Stability + + + + + + + + +... 

Prevention of heart failure through identification and management of risk factors in the preclinical phase of the disease is a priority. The concept of primary prevention has significant impact on the development of heart failure. It is estimated that the risk factors of hypertension, myocardial infarction, and diabetes contribute to 80% of the heart failure diagnosed in the United States [21]. More... 

Pharmaceutical sponsors now frequently conduct in vitro studies in the preclinical phase of drug development programs to assess the contribution of CYP or other enzymes to the metabolic elimination of an investigational drug and the ability of an investigational drug to inhibit specific metabolic pathways. The utility of these studies has been enhanced by the availability of specific enzyme preparations, microsomal preparations, and liver cell preparations, together with... 

Synthetic, natural or semi-synthetic composite materials are readily available from various commercial sources, but the quality control of a material varies substantially between medical and research grades. Many aspects of device testing have been outlined in 21 CFR 820 [22] however, during the preclinical phase of testing the most relevant of these guidelines are biomaterial composition, process validation, and design controls. 

The objective of the preclinical phase is to assure that new substances are safe for humans before they are tested in patients. The tasks of the preclinical phase are summarized in Table 10.6. 

The incredible advances in discovery technology and lead optimization over the past few years have enabled the industry to generate more compounds than ever to be tested in clinical investigations. " With this rush of new compounds for evaluation, PK/PD modeling and simulation touch various aspects of the preclinical phase of drug development. 

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