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Biopharmaceutical Acronyms & Abbreviations
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions? 
Mary Chitty MSLS 
mchitty@healthtech.com
Last revised July 09, 2019



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

ANOVA:
Analysis of Variance

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

BMS:
Bristol Myers Squibb  

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

CNVs: Copy Number Variations

CoMFA: Comparative Molecular Field Analysis 

CRA: Clinical Research Associate

CRC Clinical Research Coordinator

CRI:
Clinical Research Investigator

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

GP:
Genetic Programming


GSK:
GlaxoSmithKline http://www.gsk.com/ 

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

MHRA
: Medicines and Healthcare products Regulatory Agency, UK
  https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

MIAME: Minimum Information About a Microarray Experiment http://fged.org/projects/miame/

MOA: Mechanism of Action

MoA: Mode 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

NLP:
Natural Language Processing

NME: New Molecular Entity

NN: Neural Network
s

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

PANDRH: Pan American Network on Drug Regulatory Harmonization

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

RDF:
Resource Description Framework

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

SPC:
Structure-Property Correlation

SVM: Support Vector Machine

TME: Tumor MicroEnvironment

WHO: World Health Organization, one of the ICH Observers 


XML: 
eXtensible Markup Language


Abbreviations & Acronyms Resources
CDISC, Acronym, Abbreviations and Initials, 2010 http://www.cdisc.org/stuff/contentmgr/files/0/08a36984bc61034baed3b019f3a87139/misc/act1210_049_058_acronyms.pdf 
FDA Acronyms & Abbreviations http://www.fda.gov/aboutfda/fdaacronymsabbreviations/default.htm 

IUPAC, Abbreviations and acronyms used in the Toxicology Literature https://sis.nlm.nih.gov/enviro/iupacglossary/annex1.html
IUPAC, Abbreviations and acronyms of names of International Bodies http://sis.nlm.nih.gov/enviro/iupacglossary/annex2.html
 
NIH Institutes, Centers & Offices https://www.nih.gov/institutes-nih/list-nih-institutes-centers-offices
NIH, Office of Extramural Research, Grants and Funding Glossary & Acronyms 2013  
http://grants.nih.gov/grants/glossary.htm  
     NIH Acronym list, 2014  
http://grants.nih.gov/grants/acronym_list.htm

How to look for other unfamiliar  terms

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