Final answer:
Non-clinical studies require rigorous safety and pharmacokinetic evaluations according to guidelines provided by regulatory authorities like ICH, EMA, and FDA. These evaluations, combined with ethical considerations, ensure that only compounds with an appropriate safety profile and therapeutic potential proceed to human trials.
Step-by-step explanation:
The considerations for 'Development plan in non-clinical studies' include:
- Pharmacokinetic evaluation: This involves evaluating the pharmacodynamic, pharmacokinetic, and toxicological information of promising compounds in relevant animal species.
- In vivo studies: In vivo studies help assess the bioavailability and pharmacokinetic properties of lead compounds, along with in vitro results.
- Phase II and III clinical trials: These trials involve analyzing the dose/exposure response, establishing effective doses, and assessing the efficacy and safety profile of a compound in diverse patient populations.