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BioPharmaceutical
Glossaries & Taxonomies Site Map
Finding aids:
Drug discovery & development term index
Chemistry
term index Informatics term index
Technologies term
index Biology term index
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
Evolving Terminology for Emerging Technologies
Comments? Questions?
Revisions?
Mary Chitty MSLS mchitty@healthtech.com
Last revised
February 06, 2019
Diagnostics
almost always precede therapeutics
and
Include Biomarkers; combination drugs/diagnostics;
CNVs,
SNPs & other genetic
variations; genetic
testing
and
technologies
such as sequencing, genotyping,
haplotyping. Personalized Medicine
& pharmacogenomics
is important.
Drug
Discovery: Drug
targets & disease targets
includes drug target classes such as
GPCRs, kinases, ion channels; disease targets, target identification and
validation
Drug development includes ADME- pharmacology, animal models, drug
repurposing, combination products – drug/drug, drug/diagnostic, drug/device,
drug delivery
& formulation
Biologics can include antibodies,
cell therapeutics: stem cells, protein
therapeutics, vaccines, gene therapy and organ transplants.
Drug
discovery & development overview
Drug discovery
term index
Chemistry
medicinal & pharmaceutical
Drugs are
typically small
molecules. Assays & screening,
Cheminformatics
Combinatorial libraries & synthesis,
Chemistry
term index
Regulatory
includes GxP: GLP Good
Laboratory Practice, GMP Good Manufacturing Practice, GCP Good Clinical
Practice, ethics, and regulatory agencies
Business of
pharmaceuticals
Pharmaceuticals take decades and
billions of dollars and euros to get to market – and keep them there.
Includes
Alliances & collaboration,
Finance & pharmacoeconomics ,
Life
sciences
Intellectual property
& law
Informatics
Making
sense of the data is often the biggest challenge
Includes
Drug
discovery & development informatics including molecular
modeling,
Bioinformatics ,
Cheminformatics/Chemoinformatics;
Genomic Informatics
Protein
Informatics
Clinical &
Medical Informatics
Information management &
interpretation,
IT
infrastructure.
Ontologies & taxonomies
Informatics term
index
Drug delivery
technologies: including devices, liposomes, nanoparticles
Molecular Imaging
Nanoscience
RNA
RNAinterference Cell
& tissue technologies
Stem cells Technologies term index
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