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Biopharmaceutical Acronyms & Abbreviations
Abbreviations for techniques, compounds, and concepts have long been used in the scientific literature. Whereas this practice may have advantages for communication among scientists working in the same field as the user, it can contribute substantially to difficulties in communication between scientists working in different fields, as well as in teaching and abstracting. The proliferation of abbreviations composed of sequences of initial letters selected from the words, or from syllables, of frequently used terms has undesirable consequences and is therefore of concern to the International Union of Pure and Applied Chemistry (IUPAC). https://iupac.org/cms/wp-content/uploads/2016/01/ICTNS-Use-of-abbreviations-in-the-chemical-literature.pdf Is ACS American Chemical Society or American Cancer Society? Is CRO Clinical Research Organization or Contract Research Organization? Best to spell out all abbreviations at first use [although well established abbreviations, such as DNA or RNA are exceptions.) . Drug discovery & development term index Regulatory Informatics term index Technologies term index Biology term index Finding guide to terms in these glossaries. This is a work in progress. ADME:
Absorption, Distribution, Metabolism, Excretion ANN:
Artificial Neural Networks
AWS: Amazon Web
Services BioPax: Biological Pathways Exchange. A collaborative effort to create a data exchange format for biological pathway data. http://www.biopax.org/
BISTI:
Biomedical Information Science & Technology Initiative
https://bisti.nih.gov/Pages/Home.aspx
CAMD: Computer
Aided Molecular Design
CAMD:
Computer-Assisted Molecular Design
CAR: Chimeric
Antigen Receptors
CAMM:
Computer-Assisted Molecular Modeling CBER: Center for Biologics Evaluation and Research FDA CDER: Center for Drug Evaluation and Research, FDA CDRH: Center for Devices and Radiological Health, FDA
CDS: Cellular
Dielectric Spectroscopy CFR: Code of Federal Regulations. Title 21 covers Food and Drugs CFSAN: Center for Food Safety and Applied Nutrition cGMP: current Good Manufacturing Practice CLIA: Clinical Laboratory Improvement Amendments CNPs:
Copy
Number Polymorphisms
CoMFA: Comparative Molecular Field Analysis CRA: Clinical Research Associate
CRC
Clinical Research Coordinator CRISPR:
(Clustered Regularly Interspaced Short
Palindromic Repeats)/Cas9
DAG: Directed
Acyclic Graph
DLS:
Dynamic Light Scattering EA:
Evolutionary Algorithm EBI: European Bioinformatics Institute, Hinxton, Cambridge, UK. An EMBL outstation. http://www.ebi.ac.uk/ eCTD: Electronic Common Technical Document http://www.fda.gov/cder/regulatory/ersr/ectd.htm EMA: European Medicines Agency was EMEA: European Medicines Evaluation Agency EFPIA: European Federation
of Pharmaceutical Industries and Associations eSNPs:
expression SNPs FAIR data: Findable
Accessible Interoperable Reusable
FD: Factorial
Design FDA Food and Drug Administration FDAMA: Food and Drug Modernization Act of 1997
FLOP: Floating
point operations per second GA:
Genetic Algorithms GCP: Good Clinical Practice GLP: Good Laboratory Practice GMP: Good Manufacturing Practice
GO: Gene
Ontology
GWAS: Genome
Wide Association Sequencing
GxP: GLP, GMP,
GCP HCV: Hepatitis C HIPAA: Health Insurance Portability and Accounting Act, Health & Human Services, US
I2B2:
Informatics for Integrating Biology & the Bedside ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IDE: Investigational Device Exemption
InChI:
International Chemical Identifier IND: Investigational New Drug Application
IO: Immuno-Oncology IRB: Institutional Review Board
IUPAC: International
Union of Pure & Applied Chemistry IVDMIA: in Vitro Diagnostic Multivariate Index Assays
IVR: Immersive Virtual Reality
J&J, jnj: Johnson & Johnson http://www.jnj.com/ Many companies come under the Johnson & Johnson name. KOLs: Key Opinion Leaders
LSID: Life
Sciences Identifiers MDUFA: Medical Device User Fee and Modernization Act
MedDRA:
Medical Dictionary for Regulatory Activities MIAME: Minimum Information About a Microarray Experiment http://fged.org/projects/miame/ MOA:
Mechanism of Action
NCBI: National
Center for Biotechnology Information
NCBO:
National Center for Biomedical Ontology NCE: New Chemical Entity NCTR: National Center for Toxicological Research, FDA NDA: New Drug Application
NGS: Next
Generation Sequencing
NHGRI: National
Human Genome Research Institute
NME:
New Molecular Entity
OASIS:
Organization for the Advancement of Structured Information Systems
OBO Foundry: Open Biological and Biomedical Ontology
OPEN-BIO: Open
Bioinformatics Foundation OTC: Over the Counter drugs
OWG:
Ontology Working Group
PCR: Polymerase
Chain Reaction PDMA: Pharmaceuticals and Medical Devices Agency, Japan PDUFA: Prescription Drug User Fee Act https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ Pgx: may be pharmacogenomics or pharmacogenetics. PhRMA: Pharmaceutical Research and Manufacturers of America PMA: PreMarket Approval PSUR: Periodic Safety Update Report
QSAR:
Quantitative Structure-Activity Relationships
REMS: Risk Evaluation and Mitigation Strategy
RNAi : RNA
interference
SAR: Structure
Activity Relationship
SIMCA: (SIMple
Classification Analysis or Soft Independent Modeling of Class Analogy)
SKOS: Simple
Knowledge Organization System
SVM: Support
Vector Machine WHO: World Health Organization, one of the ICH Observers
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