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Veterinary Pharmacology and Pharmacokinetics, Bibliographic Assistance, Tissue Residues and Product RegistrationPharmacokinetics in domestic animals.Tissue residues of veterinary drugs.Milk residues of veterinary drugs.Pharmaco-toxicological monographs for veterinary drugs.Registration and development of veterinary pharmaceuticals.Expert-Pharmaceutical RegistrationTechnical support for the development and registration of more than 200 pharmaceutical products for veterinary use in Argentina and Latin America.Independent Consultant...
Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...
Medicinal Chemist Specializing in the Design and Synthesis of Antibacterials and other Antiinfectives. Drug Development and Project Management from idea to Clinical Trials.Antibacterial chemotherapy including beta-lactams, quinolones, DNA - gyrase and top IV inhibitors, peptide antibacterials, pleuromutilins, glycopeptides, oxazolidinones, 2-component signaling, natural products, single enzyme targets such as the Fab and Mur proteins, GlmU, LpxC, and mechanism based small molecule inhibitors projects.Antiviral chemotherapy: HIV and Herpes antivirals, HIV protease, HIV integrase, HIV-NCp7 (nucleocapsid protein).All aspects of medicinal che...
Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience.
Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs. Experience in Summary
Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries. Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts. Creative, collaboration and highly goal-driven scientist.
Expert in Ligand Binding Assays including immunogenicity.
Successfully implemented complex acid...
Senior pharmaceutical R&D professional focused on analytical methods, methods validation, validation of computer systems and quality assurance and quality systems. Experience with parenterals, liquids, solids and semi-solids.Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.Stability-indicating method development, validation and transfer.Analytical equipment validation: IQ, OQ, PQ.Part 11 compliance and GAP analysis.Validation master plan development.Stability protocol development.CTD dossier preparation.Cleaning validation strategy.LIMS and Laboratory Data Acquisition Computer systems.Coumadin, Percodan, Naloxone, Numorphan and N...
Medicinal chemist and Pharmaceutical Technology Consultant with Expertise in Drug Research, Drug Formulation, Drug Analysis, Drug Synthesis and Purification, In-Vitro, In-Vivo (Efficacy and Pharmacokinetics) and Dosing RoutsDiscovery and development of novel human therapeutics for: Anti-infective, anti-inflammatory and neurodegenerative diseases.Development of antibacterial clinical candidates, and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.Drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formul...
Consultant for Pharmaceutical Marketing Research and Drug Program ManagementSenior consultant with 15 years of research experience in academic and industrial settings with a Ph.D. in Immunology.Marketing research of competitive assessment of pharmaceutical market segments and geographical regions.Pharmaceutical and biotechnology drug development, drug company portfolio analysis, strengths, weaknesses and opportunity assessment.Pharmaceutical and biotechnology drug and intellectual property valuation.Clinical trials, FDA filings, product lifecycle management and project management.Experience in collaborating with customers, at different le...
Consultant in Drug Discovery and Development; Preclinical and Clinical Drug Metabolism and Pharmacokinetics, Toxicokinetics, and Clinical Pharmacology; Preparation and Submission of IND's/ERC's and NDA's/MAA's.Over 35 years of experience in the discovery and development of novel drugs in multiple therapeutic areas (anti-bacterial, anti-inflammatory, anti-viral, cardiovascular, central nervous system, oncology, ophthalmic, pulmonary, and renal).Strong managerial and leadership skills with scientific expertise in the areas of drug discovery and development, preclinical and clinical drug metabolism, pharmacokinetics, and clinical pharmacology...
Pharmacokinetics Consultant Specializing in Drug Metabolism, Drug Discovery and Early Drug Development.ADME, (Absorption, Distribution, Metabolism, and Excretion) and PK (Pharmacokinetics) in drug discovery.Early drug development.In vivo and in vitro enzyme induction.Cytochrome P450 enzyme inhibition and potential for drug-drug interaction.In vitro and in vivo metabolism and metabolite profiling.Preclinical studies to evaluate ADME, toxicokinetics, and PK profile of drug candidates.Due diligence to evaluate DMPK profile of drug candidates for potential purchasing or in-licensing opportunities.Interaction with CROs for contracting and monit...
Pharmaceutical Statistics Data Analysis and Clinical Trial DesignPharmaceutical bio-statistician.Pharmacokinetics and data analysis for clinical trials.CNS: Schizophrenia, bipolar disorder, Alzheimer's disease, migraine and over-active bladder.CV: Hyperlipidemia, diabetes (novel PPAR y & %u0105, atrial fibrillation, anti-platelet agent.Oncology: VEGFR EGFR inhibitors, lung and thyroid cancer, non-small cell lung cancer, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), advanced solid tumors.Immunology: Malignant melanoma (DNA immunotherapy, hepatitis B and C (PEG-Inetrferon), H5N1 vaccine, RNAactive-derived vaccine (for p...