ABSTRACT
The course of development of an individual organism through successive transformations in a lifetime is referred to as ontogeny. Consequences of developmental changes and thus drug dosage modifications based on age, liver function, renal function, and other intrinsic and extrinsic factors have been well known for some time. Some examples of intrinsic factors are genotype, gender, ethnicity, inherited diseases, acquired diseases, age specific diseases, and polymorphism, and examples of extrinsic factors include smoking, drug abuse, environmental pollutants, xenobiotic exposure, and diet factors. During drug development it is not always possible to include enough number of patients in pivotal clinical trials, to represent each subpopulation. These subpopulations-also called special or specific populations-include different ethnic and racial groups, age groups, genders, pregnancy, lactation, and certain types of disease states (liver and renal impairment) which may affect drug disposition, obesity, smokers, etc. Pharmacokinetic (PK) and/or pharmacodynamic (PD) differences for all these subgroups have been reported in the literature. In this book, pregnancy and lactation have been discussed in Chapter 13, drugdrug interaction in Chapter 14 and effects of certain disease states have been presented in Chapter 15.
