For biological products, any such claim must be based on substantial evidence. Information regarding nonlinearity in pharmacokinetic parameters, changes in pharmacokinetics over time, and binding (plasma protein, erythrocyte) parameters must also be presented if clinically significant. For a system to undergo a spontaneous change at constant temperature and pressure the Gibbs free energy must decrease, but how? The reverse reaction, as written above, is not spontaneous. A reaction must be spontaneous if its occurrence is (1) endo | Quizlet Which series of physical changes represents an entropy increase during each change? A reaction of this type is always spontaneous because the entropy of both the surroundings and the system are increased by its occurrence. If studies demonstrate the presence of the drug and/or its active metabolite(s) in human milk but the drug and/or its active metabolite(s) are not expected to be systemically bioavailable to the breast-fed child, the Risk Summary must describe the disposition of the drug and/or its active metabolite(s). Used to clean the inside of test tubes or graduated cylinders (iwer srbuh)________________11. By clicking Post Your Answer, you agree to our terms of service and acknowledge that you have read and understand our privacy policy and code of conduct. (7) Dosage and administration. (11) Adverse reactions. A reaction must be spontaneous if its occurrence is exothermic with an increase in entropy. Significant animal data necessary for safe and effective use of the drug in humans that is not incorporated in other sections of labeling must be included in this section (e.g., specifics about studies used to support approval under 314.600 or 601.90 of this chapter, the absence of chronic animal toxicity data for a drug that is administered over prolonged periods or is implanted in the body).