THE GENDER PERSPECTIVE IN DRUG DESIGNING AND DEVELOPMENT PROCESSES- A REVIEW

It has long been assumed that females have the same response as males to the drugs in all the five phases of drug development processes namely drug discovery & development, preclinical trials, clinical trials, drug review and drug marketing. The fact is that the diseases exhibit the potential sex difference in its prevalence, diagnosis, severity and outcomes. Diseases like breast cancer, urinary tract infections affect men and women differently. The difference also exits in the manifestation of the diseases like cardiovascular disease and sexually transmitted diseases. The differences of the sex are further widened by the gender perspective. Gender is one of the fundamental determinants of health inequalities. There are differences in the physiology of the sexes that causes difference in the pharmacodynamics for specific drug which can be due to the circulating levels of endogenous hormones such as testosterone and estradiol. Women typically have a lower bodyweight than men, so when taking the same dose of a drug results in higher level of drug. Lyophilic agents may have a larger distribution in females owing to their higher body fat content. Women may experience different health issues due to cultural, social and economical factor and hence it becomes an issue related to gender bias. There is a need to examine the potential difference by sex at all the life stages at all the levels, like genetic and cellular level to organism level. Also, there is a need to take into consideration this sex difference in all the stages of the drug development, pre-clinical and clinical trial. It has been observed that while studying diseases prevalent in both the sexes only male animals were considered to be norm study population. It was assumed that female would have same response as males during the pre-clinical trials and that women will have same response as men from drugs in the clinical trials. The assumption of equality puts women at risk, not only reducing disease treatment efficacy but also risking exposure to unforeseen side effects. Women have been viewed as more expensive test subjects because of their more fluctuating hormone levels. It has to take the possible hormonal interaction into consideration during the pharmacodynamics, pharmacokinetics when it comes to determine the safety, efficacy and tolerance of new drugs. Although there have been lack of representation of women in clinical trials initially due to non availability of data that the potential sex differences exist but now guidelines, policies and organizations have been established to increase the quality of women's health research. In 1993, the National Institute of Health Revitalization Act came into being to promote inclusion of women in clinical trials. The acceptance that sex differences should be considered while taking clinical decisions itself proves that there has been a major breakthrough, but a lot is to be done. The studies on cardiovascular disease pattern for males and females creates awareness and the governments are making policies and guidelines for the gender specificity in the drug designing and development processes and strict enforcement during the approval processes. There is along way to go.