Pharmaceuticals - , Michigan, United States
ProPharma Services LLC is a company that consists of a group of consultants with wide-ranging experience in the pharmaceutical industry. Our main focus is to provide consulting with two areas of expertise: (1) Early discovery and lead optimization for small molecules- Provide input into early drug discovery strategy - Extensive knowledge of small molecule metabolism (ADME, CYP reaction phenotyping, enzyme kinetics, induction, extrapolation of in vitro/in vivo data to projected human pharmacokinetics) - Pharmacokinetics/toxicokinetics analysis (PK/PD and pharmacokinetic modeling) - Experience with predicting small molecule drug-drug interactions - Assessment of compound liabilities both in the context of drug discovery/development, and in-licensing opportunities(2) Large and small molecule development- Generation of IND enabling documents (PK reports etc…)- Very experienced with IND/IB/CTD writing - Preclinical and clinical pharmacokinetics/toxicokinetics. Our group has experience with preclinical PK analysis (in context with supplementary ADA data for large molecules) and report generation as well as procedures and SOPS in place to handle preclinical GLP TK. In addition, we have procedures and SOPs which are FDA audit compatible to facilitate clinical pharmacokinetic analysis.Members: Sharon Baughman [ph - (805) 616-1414]Michael Schrag [ph - (805) 914-4710]Kelly Regal [ph - (303) 499-9164]Terry Podoll www.propharmaserv.comwww.propharmaservices.org
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