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Pharmaceutical Glossaries & Taxonomies Site Map
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions? Mary Chitty  mchitty@healthtech.com
Last revised March 23, 2012

 

Diagnostics almost always precede therapeutics
Includes Biomarkers; combination drugs/diagnostics; CNVs, SNPs & other genetic variations; genetic testing and technologies such as sequencing, genotyping, haplotyping Personalized Medicine & pharmacogenomics is important. 

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
Drug Discovery: Drug targets & disease targets includes drug target classes such as GPCRs, kinases, ion channels; disease targets, target identification and validation
Biology
 Includes Cell biology  Genomics , Proteomics, RNA  Pharmaceutical biology Much of this research is pre-competitive  Basic genetics & genomics  Biology overview  
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

Bioprocessing & manufacturing: Compounds are needed for preclinical samples up through large scale manufacturing

Chemistry medicinal & pharmaceutical
 Drugs are typically small molecules. Includes Assays & screening, Combinatorial libraries & synthesis, protein chemistry  Chemistry  term index

Regulatory  includes GxP: GLP Good Laboratory Practice, GMP Good Manufacturing Practice, GCP Good Clinical Practice, ethics, and regulatory agencies

Therapeutic indications/franchises include Cancer/Oncology, Cardiovascular, CNS/Neurology, Immunology, Infectious Diseases and Medical Specialties endocrinology, gastrointestinal, geriatrics, pediatrics

Therapeutics include drugs, biologics, antisense, gene therapy

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
Business of pharmaceuticals Pharmaceuticals take decades and billions of dollars and euros to get to market and keep them there.
Includes Alliances & collaboration Finance & pharmacoeconomicsLife 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 analysis & interpretationIT infrastructure.   Ontologies & taxonomies  Informatics term index

Technologies  New technologies can reveal the preciously unobservable
 include
Biomaterials & bioengineering Genomic technologies : Genetic Manipulation & Disruption  Microarrays  PCR  Sequencing Protein Technologies: Mass spectrometry    NMR synchrotrons & x-ray crystallography ;  Drug delivery technologies: including devices, liposomes, nanoparticles; Molecular Imaging, medical devices, Nanoscience  RNAinterference  Cell & tissue technologies  Stem cells   Life Sciences Technologies term index

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