Overview of the market: What are the unmet needs of currently available therapies? Which competitor compounds/classes of compounds are in the clinic/late development?
Introduction to the compound
Pharmacodynamics: Effect of the drug on the body, including receptor binding, post-receptor effects, and chemical interactions.
Pharmacokinetics and metabolism: Effect of the body on the drug, including time course of absorption, bioavailability, distribution, metabolism, and excretion. To provide the reader with a visual summary of the pharmacokinetics of the drug, each paper should include a table summarizing published pharmacokinetic parameters, e.g. AUC, Cmax, Cmin, Ctrough, Tmax, oral clearance CL/F, (Table 1. Summary of pharmacokinetic parameters of [drug].) ADME properties as they relate to toxicity (toxicokinetic).
Pharmacogenetics: Effect of genetic differences on response to drugs (where data is available). Clinical/population pharmacokinetics.
Clinical efficacy: Summary of clinical efficacy data from Phase I-III studies and post-marketing surveillance.
Safety, tolerability, toxicity, and potential off-target effects related to safety liabilities: Indicate changes in biomarkers of harm as appropriate.
Regulatory affairs: Indicate drug approvals from a global perspective.
Conclusion: An analysis of the data presented in the review.