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Glossaries & Taxonomies Site Map
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Drug safety is always a critical consideration from
preclinical through Pharmacovigilance/Phase IV/Post
Marketing Surveillance
Includes adverse drug effects, toxicology [often organ specific – cardiotoxicity, hepatotoxicity,
nephrotoxicity, idiosyncratic toxicities, also device and
diagnostics safety
Drug
discovery & development
preclinical
up to first in human
Therapeutics include drugs,
typically small molecules
biologics
antibodies,
antisense, cell
therapies, gene therapy
Bioprocessing & manufacturing: Compounds are
needed for preclinical samples up through large scale manufacturing
Therapeutic
indications/franchises include Cancer & Oncology,
Cardiovascular, CNS/Neurology,
Immunology, Infectious Diseases and Medical Specialties
– endocrinology, gastrointestinal,
geriatrics, pediatrics
Clinical
trials go from Phase zero [first in human] through Phase
IV/pharmacovigilance Includes clinical
trial design/protocols; ethics: HIPAA, IRBs; outsourcing, trial
logistics & management: budgeting, clinical site selection, patient recruitment, supply chain management,
training
and
trial team members: clinical investigators, sponsors, CRAs Clinical
Research Administrators, CRCs Clinical Research Coordinators
Healthcare From translational research to
translational medicine Includes
Molecular
Medicine, business,
informatics, and topics such as comparative effectiveness research,
evidence based medicine, electronic medical records, pharmacy benefit
management, managed care
Enabling
factors Necessary but not necessarily
sufficient. Ethics
Technologies
New
technologies can reveal the preciously unobservable
and include
Biomaterials, bioengineering & medical devices
Genomic
technologies
Genetic Manipulation & Disruption
Microarrays
PCR
Sequencing
Protein
Technologies including
Mass spectrometry
NMR synchrotrons & x-ray crystallography About the Biopharmaceutical/ Genomic glossaries & taxonomies How to look for other biopharmaceutical unfamiliar terms Pharmaceutical Bibliography book drug safetymap temp |
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