The nurse, assisting with Phase I drug studies, is talking with a woman who asks, “Why can't I participate in this study”? What would be the nurse's best response?

a) While men and women may metabolize drugs differently, this is not the primary reason why women are often excluded from Phase I drug trials. b) Women are not necessarily more prone to adverse effects, but concerns about fetal exposure and reproductive risks have historically limited women's participation in early trials. c) This statement is incorrect and misleading. Drug trials are not based on strength but rather on safety, ethical concerns, and risk of reproductive harm. d) Phase I studies test drugs on healthy volunteers, and historically, women of childbearing age were excluded due to concerns about potential teratogenic effects and unknown risks to a developing fetus. Although regulations have changed, caution is still exercised when including women in early-stage drug trials.