DSE Consulting Services

DSE Consulting offers pharmaceutical and biotechnology companies a variety of research services to assist in the characterization of discovery leads and drug candidates.  Research studies can be conducted either in the client's facilities or at an appropriately selected and monitored CRO.  For more information on any of the services listed below, please contact DSE Consulting.

Developability assessment for discovery lead selection.  (Short Course)  (White Paper)

Logic plan generation and/or evaluation.

Definition of study designs and protocols.

Implementation and conduct of research studies.

Evaluation, interpretation, and integration of results from various scientific disciplines.

Drug development program assessment or generation.  (Short Course)

Projected research studies for various research groups or departments.

Logic plan definition for the various scientific disciplines involved.

Timelines and critical path generation.

Evaluation, selection, and monitoring of CROs.    (Short course)  (White paper)

Drug discovery.

Developability assessment.

Preclinical and nonclinical drug development.

Document preparation and/or review. (Short course)

Technical or scientific reports.

Research study protocols

Standard Operating Procedures (SOPs).

Regulatory agency submission summaries.

Bioanalytical and analytical chemistry.  (White paper)

Method development for drug candidate and known metabolites (bioanalytical chemistry [BAC]) and drug substance and known impurities or degradation products (analytical chemistry).

BAC method validation for each matrix type and each species, including humans.

Inter-laboratory BAC method transfer and implementation.

Evaluation and interpretation of results.

Generation or review of technical documentation.

Pharmacokinetics and toxicokinetics. (Short course)

Study designs and research protocols for pharmacokinetic (PK) and bioavailability evaluations in animal models and humans.

Design and integration of toxicokinetics (TK) into toxicology research studies.

Pharmacokinetic studies for drug metabolites.

Drug-drug and drug-food interaction study design and implementation.

Evaluation of results and generation of pharmacokinetic profiles and parameters.

Generation or review of technical documentation.

Drug metabolism and ADME.  (Short course)

In vitro drug metabolism (CYP450 isozymes, microsomes, hepatocytes).

Preparation and characterization of an appropriately radiolabeled drug candidate.

Protein binding in various species, including humans.

Mass balance in toxicology species.

Tissue distribution (single and multiple dose) and quantitative whole-body-autoradiography (QWBA).

Drug metabolite profiling, isolation, and identification.

Species comparisons.

Feto-placental transfer and lacteal secretion studies to support reproductive and developmental toxicology research studies.

Evaluation of results and generation or review of technical documentation.

Drug delivery and formulation characterization

In vitro and in vivo assessment of delivery (GI, pulmonary, dermal, CNS).

Stability of drug substance and drug product.

Solubility of drug substance.

Evaluation of results and generation or review of technical documentation.

Pharmacology and toxicology (Short course)

Review of generated results to ascertain if pharmacological and toxicological profiles are complete and sufficient to justify continued development.

Toxicology program design or review to support regulatory agency requirements.

Toxicology program coordination at CROs.

DSE has collaborative relationships with several toxicologists.  If your consulting needs require the services of a toxicologist, contact DSE for a referral.

DSE Consulting serves as the nonclinical (pharmacology, pharmacokinetic, and toxicology) expert for Ground Zero Pharmaceuticals (GZP) clients.  More information on the services available from GZP can be obtained from the GZP website (http://www.groundzerous.com). 

Some of the DSE Consulting short courses are offered as public courses by The Center for Professional Innovation & Education (CfPIE) ( http://www.cfpie.com).  Information on scheduled public course dates can be obtained from the CfPIE websites.