Seventh Wave Laboratories LLC (now Inotiv)

Seventh Wave represents a unique alternative in the fast-paced world of preclinical drug development. By integrating PK/ADME, Bioanalysis, Toxicology, and Pathology, our organization affords the client a multi-disciplinary environment that accelerates their program with focused strategy and execution. Our approach is to work with project teams to design and execute a preclinical development program in order to meet the needs of the project. Our expertise in nonclinical development emphasizes: ADME and PK/PD Toxicology Pathology Pharmacology Quality Assurance Regulatory Interaction Due Diligence Reviews and Audits Our Laboratory Services provide preclinical pharmacokinetic (PK) and pharmacodynamic (PD) screening in a variety of animal species, in vitro metabolism, pharmacology model development and evaluation, assessment of spontaneous and induced disease models, PK/PD/TK data analysis, dynamic dissolution testing, and pathology and safety evaluations through the capabilities of our in vivo, bioanalytical and histology laboratories. Our exploratory preclinical safety evaluation approach identifies dose/exposure relationships for tolerability, as well as identification of organs and/or systems susceptible to adverse pharmacology or toxicology. The goal is to identify potential flaws in novel pharmaceutical compounds that limit their development prior to investment of significant time, dollars, and unnecessary animal use.