Our Services
Study Placement
We will identify cost-effective CRO’s (contract research organizations), who can provide nonclinical toxicology, pharmacology and genetic toxicity studies under non-GLP (GLP compliant) and GLP conditions.
Study Plans & Reports
We can write protocols and study reports for non-clinical studies, act as a Study Monitor, and review third party study reports and help in interpretation of study results. In addition, we also can do comprehensive literature searches either relevant to the study reports or written as stand alone reports that summarize data relevant to the drug development program. We can also prepare nonclinical parts of technical documents such as pre-IND’s, IND’s, CTAs, BLA, NDS’s, NDSs Briefing document, Investigator’s Brochures, etc, and provide guidance for the writing of scientific manuscripts for publication in major scientific journals.
ADME Related Services:
(i) Solubility determination
(ii) Plasma stability, liver microsomal stability and hepatocyte metabolism, CYP450 inhibition and profiling.and induction, drug-transporter interactions.
(iii) Non-compartmental and compartmental pharmacokinetic and toxicokinetic analysis of drug tissue and plasma concentrations over time.
(iv) Safety pharmacology: neurological, cardiovascular and pulmonary.
(v) Prediction of human pharmacokinetics based on allometric scaling using a single species or multiple species.
General Consulting Services
Medicinal, structural and biophysical chemistry, molecular biology, immunology, drug delivery and regulatory affairs. GO-TO-PK Solutions can help you with the procedures involved in applying for a European, US and Canadian patent (through our associates), offering practical advice through the various stages of the application process. We can review your existing nonclinical program and advise you of any potential issues. In cases where any potential issues will be out of the expertise of our team, we can identify other scientific experts, when needed, from our wide network of experts in chemistry, pharmacology and toxicology. We can also help you in designing and placing target animal safety studies for veterinary pharmaceuticals.