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BioPharmaceutical Glossaries & Taxonomies Site Map
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?
Mary Chitty MSLS  mchitty@healthtech.com
Last revised February 06, 2019

Finding aids:   Drug discovery & development term index  Chemistry term index    Informatics term index    Technologies term index    Biology term index 
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 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
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

Biology Includes Cell biology   Genomics , Proteomics, RNA  Pharmaceutical biology Much of this research is pre-competitive  Basic genetics & genomics  Biology overview  

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

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
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

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 
Drug delivery technologies: including devices, liposomes, nanoparticles
Molecular Imaging   Nanoscience    RNA  RNAinterference    Cell & tissue technologies   Stem cells   Technologies term index

About the Biopharmaceutical/ Genomic glossaries & taxonomies        How to look for other biopharmaceutical unfamiliar terms    Pharmaceutical Bibliography                                         book    drug safetymap   temp

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