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) Agonist
Ampoule (Ampule) ANDA Antagonist
Antibiotic Antibody Antifungal
Antigen Antisense Antiseptic
API Aseptic Processing Assay
Audit Audit Trail Authorized Person
Authorized Person (AP) Auto-Injector

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

C
Carcinogenic Case Report Form (CRF) CBER
CDER CDMO Cell Lines
Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) CFR
cGMP Change Control 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 CIP Clean In Place (CIP)
Cleanroom Clinical Research Associate Clinical Trials
Cmax CMC Cmin
CMO Code of Federal Regulations, Title 21 Combination Product
Combinatorial Chemistry 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) 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 Disease Pathway
Dosage Form Double Blind Downstream Processing (DSP)
Drug Delivery Drug Discovery Drug Product
DSMB DSP

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

F
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
Genome Genomics GLP
GMP GMP Facility Good Automated Manufacturing Practices
Good Clinical Practices (GCP) Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP)
Good Tissue Practices (GTP) GTP GxP

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

I
ICH In silico In vitro
In vivo In-Licensing Inactive Pharmaceutical Ingredient
IND Individualized Medicine Informatics
Installation Qualification (IQ) 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 Medicinal Chemistry
Medium Metabolic Induction Metabolic Inhibition
Metabolic Transformation Metered-Dose Inhaler (MDI) Methods Validation
Monoclonal Antibody (MAb) Mutagenic

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

O
Off-Label Use 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 Pharmacogenomics
Pharmacokinetics (PK) Pharmacology Pharmacopoeia
Pharmacovigilance Phase 0 Phase I
Phase II Phase III Phase IV
Pilot-Plant Scale PK Placebo
Polymerase Chain Reaction (PCR) 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 QC Qualification batches
Qualified Person (QP) Quality Agreement Quality Assurance (QA)
Quality by Design Quality Control (QC)

R
Radio Frequency Identification (RFID) Rational Drug Design Receptor
Registration batches Request For Information (RFI) Request for Proposal (RFP)
Request for Quotation (RFQ) Resampling Responsible Person (RP)
Retesting RFID RFP

S
SAR Scale-Up Scale-Up and Post-Approval Changes (SUPAC)
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 SUPAC
Supplemental New Drug Application (sNDA) Supply Agreement Sustained Delivery
SVP

T
Target Validation Technology Transfer Terminal Sterilization
Therapeutics Topical Transdermal
Transgenics

U
United States Pharmacopeia (USP) USP

V
Vaccine Validated Target Validation
Validation batches

W
Water For Injection (WFI) WFI

X
X-Ray Crystallography Xenobiotic