A lexicon of pharma & biopharma industry words and acronyms

Welcome to the second Contract Pharma Glossary of Terms. We’ve revised a number of entries from last year’s edition, and received numerous suggestions for revisions and additional terms from several readers (too many to list here).

If you have any suggestions for how we can enhance any of the definitions, or if you have terms you’d like to see included in the next edition of this Glossary, !

Gil Y. Roth
Editor

2   4   5   A   B   C   D   E   F   G   H   I   J   L   M   N   O   P   Q   R   S   T   U   V   W   X  

2
21 CFR Part 11

4
483 Letter

5
505 (b) (2) submission

A
Abbreviated Antibiotic Drug Application (AADA) Abbreviated New Drug Application (ANDA) Absorption, Distribution, Metabolism and Excretion/Toxicology (ADME/T)
Action Letter Active Pharmaceutical Ingredient (API) ADME/T
ADR Adverse Drug Reaction (ADR) AFSSAPS
Agonist Amino Acids Ampoule (Ampule)
ANDA Antagonist Antibiotic
Antibody Antifungal Antigen
Antimicrobials Antisense Antiseptic
API Aseptic Processing Assay
Asymmetric Synthesis Audit Audit Trail
Authorized Person (AP) Auto-Injector

B
Bacteria Batch Bio-Intermediate
Bioanalysis (Bioanalytical) Bioassay Bioavailability
Bioburden Biocatalysis Biocatalyst
Biocide Bioequivalence Biogeneric
Bioinformatics Biological Biological Pathway
Biologics License Application (BLA) Biometrics Biopharmaceutical
Bioprocess Bioreactor Biosimilar
Biosynthesis Biotechnology Biotransformation
BLA Blister Pack Blow (Form), Fill, Seal
BPC British Pharmacopoeia (BP) Bulk Pharmaceutical Chemical (BPC)

C
Capacity Utilization Carcinogenic Case Report Form (CRF)
CBER CDER CDMO
Cell Cell Banks Cell Culture
Cell Lines Cell Therapy Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER) CFR cGMP
Change Control Change Order Characterization
Chemical Process Development Chemical Synthesis and Scale-Up Cheminformatics
Chemistry, Manufacturing, and Controls (CMC) Child Resistant (CR) Chimera
Chinese Hamster Ovaries (CHO) Chiral Compound CHO
Chromatography Chromosomes CIP
Clean In Place (CIP) Cleanroom Clinical Research Associate
Clinical Trials Clone Cmax
CMC Cmin CMO
Code of Federal Regulations, Title 21 Codon Combination Product
Combinatorial Chemistry Commodity Chemical Compliance
Compliance Computational Biology Computational Chemistry
Computer Systems Validation Contract Development and Manufacturing Organization Contract Manufacturing Organization (CMO)
Contract Research and Manufacturing Services (CRAMS) Contract Research Organization (CRO) Controlled Release Formula
Cooperative Research and Development Agreement (CRADA) Cosmeceutical COX-2 Inhibitor
CR CR&M CRA
CRADA CRAMS CRF
CRO Crystallography current Good Manufacturing Practices (cGMP)

D
Data and Safety Monitoring Board (DSMB) DDS Derivatives
DGCI Disease Pathway DNA
Dosage Form Double Blind Downstream Processing (DSP)
Drug Delivery Drug Discovery Drug Product
Drug Substance DS DSMB
DSP

E
E-Pedigree (alt. ePedigree) ECTD EDC
Efficacy EHS Electronic Data Capture (EDC)
EMEA Enantiomers Endpoint
Engineering Batch Environmental Health and Safety (EHS) Enzyme
Escherichia Coli or E.coli European Agency for the Evaluation of Medicinal Products (EMEA) European Pharmacopeia (EP)
Excipient Expression Extractable

F
FAB Fast Track FDA
FDAMA Field Alert Fill and Finish
Food and Drug Administration Form 483 Form, Fill, Seal
Freeze Dry and/or Freeze Dryer Functional Genomics

G
GAMP Gas Chromatography (GC) GCP
Gene Gene Therapy Generic Drug
Genetic Engineering Genome Genomics
GLP Glycosylation GMP
GMP Facility Good Automated Manufacturing Practices Good Clinical Practice (GCP)
Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP) Good Tissue Practice (GTP)
GS Expression System GTP GxP

H
Half-Life High Pressure Liquid Chromatography (HPLC) High-Throughput Screening (HTS)
HIPAA Hit Host System
HPLC HTS Humanization
Hybridoma

I
ICH Ig In silico
In vitro In vivo In-Licensing
Inactive Pharmaceutical Ingredient IND Individualized Medicine
Infectious Diseases Informatics Installation Qualification (IQ)
Interferons International Conference on Harmonization (ICH) International Organization for Standardization (ISO)
Investigational New Drug Application (IND) Investigator IQ

J
Japanese Pharmacopoeia (JP)

L
Laboratory Information Management Systems (LIMS) Large Volume Parenteral (LVP) LC/GC
LC/MS-MS Leachables Lead
Lead Compound Lead Discovery Lead Optimization
Legacy Systems Ligand LIMS
Liposome Liquid Chromatography/Gas Chromatography (LC/GC) Liquid Chromatography/Mass Spectrometry (LC/MS)
Lot LVP Lyophilization
Lyophilizer

M
MAb Mass Spectrometer Master Cell Bank
Master Service Agreement Medicinal Chemistry Medium (pl. Media)
Metabolic Induction Metabolic Inhibition Metabolic Transformation
Metered-Dose Inhaler (MDI) Methods Validation MHLW
MHRA Monoclonal Antibody (MAb) MSA
Mutagenic

N
National Formulary NCE NDA
Neoplastic New Chemical Entity (NCE) New Drug Application (NDA)
Non-Research Development Organization (NRDO) Nucleic Acids Nucleotides
Nutraceutical

O
Off-Label Use Oligonucleotides Oncogenic
Operational Qualification (OQ) OQ Oral Solid Dosage
Orange Book Orphan Drugs OTC
Out of Specification (OOS) Out-Licensing Out-of-Trend (OOT)
Over the Counter (OTC)

P
PAI Parenteral Drug PAT
Patent PCR PDUFA
Peptide Pharmacodynamics (PD) Pharmacoeconomics
Pharmacogenetics Pharmacogenomics Pharmacokinetics (PK)
Pharmacology Pharmacopoeia Pharmacovigilance
Phase 0 Phase I Phase II
Phase III Phase IV Phenotype
Pilot-Plant Scale PK Placebo
Plasmids Polymerase Chain Reaction (PCR) Post-translational Modification
PQ Pre-Approval Inspection (PAI) Preclinical studies
Preformulation Prescription Drug User Fee Act (PDUFA) Primary Packaging
Process Analytical Technologies (PAT) Process Qualification (PQ) Process Validation
Protein Proteome Proteomics
Protocol

Q
QA QbD QC
Qualification batches Qualified Person (QP) Quality Agreement
Quality Assurance (QA) Quality by Design Quality Control (QC)
Quantitative Whole Body Autoradiography

R
Radio Frequency Identification (RFID) Rational Drug Design Receptor
Registration batches REMS Reprocessing
Request For Information (RFI) Request for Proposal (RFP) Request for Quotation (RFQ)
Resampling Responsible Person (RP) Retesting
RFID RFP Risk Evaluation and Mitigation Strategy (REMS)
RNA

S
SAR SBA Scale-Up
Scale-Up and Post-Approval Changes (SUPAC) Secondary Metabolism Secondary Metabolites
Secondary Packaging Single Nucleotide Polymorphism (SNP) Small Molecule Drug
Small Molecule Library Small Volume Parenteral (SVP) sNDA
SNP Solid Dosage SOP
Special Protocol Assessment (SPA) Specialty Pharma Stability
Standard Operating Procedures Statin Structural Genomics
Structure-Activity Relationship (SAR) Structure-Based Drug Design Summary Basis of Approval
SUPAC Supplemental New Drug Application (sNDA) Supply Agreement
Sustained Delivery SVP

T
Target Product Profile Target Validation Technology Transfer
Terminal Sterilization TGA Therapeutics
Topical TPP Transcription
Transdermal Transfection Transgenic Organism
Transgenics Translation Transmissible Spongiform Encephalopathy (TSE)

U
United States Pharmacopeia (USP) USP

V
Vaccine Validated Target Validation
Validation batches Vitamin

W
Warning Letter Water For Injection (WFI) WFI
Working Cell Bank World Health Organization (WHO)

X
X-Ray Crystallography Xenobiotic