drug development
Therapeutic compound research
Drug development is the process of bringing a new pharmaceutical compound from initial discovery to approved medication.
It encompasses laboratory research, preclinical testing in animals, multiple phases of human clinical trials, and regulatory review.
The process typically spans a decade or more and costs hundreds of millions of dollars: The company has three candidates in drug development.
Most compounds fail somewhere along the pipeline.
Drug fate in body
- bioavailabilityFraction reaching active circulation
- half-lifePeriod for fifty-percent reduction
- metabolismCellular nutrient conversion
- absorptionProcess of taking in
distribution · excretion · dosage · efficacy · potency · receptor · agonist · antagonist
Act of finding something
- screeningEvaluative selection process
- preclinicalBefore human trials
- synthesisCombining parts into whole
- formulationDevised mixture or expression
high-throughput · optimization · validation · proof-of-concept · in-vitro · toxicology
Drugs derived from organisms
- biosimilarsNear-copies of biologic medicines
- recombinantGenetically engineered combination
- bioreactorVessel for growing organisms
- fermentationMicrobial sugar conversion
CRISPR · mRNA · peptide · purification · upstream · downstream · bioprocessing · characterization
U.S. health regulator
- approvalFavorable opinion given
- submissionYielding to another's will
- NDASecrecy contract, abbreviated
- INDUniversal drug nomenclature
compliance · guidelines · review · fast-track · labeling · GMP · GCP · inspection
Formal legal proceedings
- phasesDistinct periods in sequence
- enrollmentAct of registering officially
- placeboInactive therapeutic substitute
- randomizationIntroducing chance systematically
double-blind · endpoints · protocol · cohort · multicenter · investigator · sponsor · follow-up
Obvious; inventor's monopoly
- licensingGranting official permission
- pricingEstablishing monetary amounts charged
- launchSet into motion
- manufacturingIndustrial product creation
scale-up · supply-chain · partnership · acquisition · exclusivity · generic · reimbursement · payer
pharmacokinetics
Drug fate in body
- bioavailabilityFraction reaching active circulation
- half-lifePeriod for fifty-percent reduction
- metabolismCellular nutrient conversion
absorption · distribution · excretion · dosage · efficacy · potency · receptor · agonist · antagonist · inhibitor
discovery
Act of finding something
- screeningEvaluative selection process
- preclinicalBefore human trials
- synthesisCombining parts into whole
formulation · high-throughput · optimization · validation · proof-of-concept · in-vitro · toxicology
biologics
Drugs derived from organisms
- biosimilarsNear-copies of biologic medicines
- recombinantGenetically engineered combination
- bioreactorVessel for growing organisms
fermentation · CRISPR · mRNA · peptide · purification · upstream · downstream · bioprocessing · characterization
FDA
U.S. health regulator
- approvalFavorable opinion given
- submissionYielding to another's will
- NDASecrecy contract, abbreviated
IND · compliance · guidelines · review · fast-track · labeling · GMP · GCP · inspection · dossier
trials
Formal legal proceedings
- phasesDistinct periods in sequence
- enrollmentAct of registering officially
- placeboInactive therapeutic substitute
randomization · double-blind · endpoints · protocol · cohort · multicenter · investigator · sponsor · follow-up
patent
Obvious; inventor's monopoly
- licensingGranting official permission
- pricingEstablishing monetary amounts charged
- launchSet into motion
manufacturing · scale-up · supply-chain · partnership · acquisition · exclusivity · generic · reimbursement · payer · outsourcing
- Biomedicineanatomy, physiology, pathology, pharmacology, immunology
- BiotechDNA, bioengineering, genetic testing, gene, DNA sequencing
- medical researchmedical research, clinical trial, biomedical research, cancer research, clinical trials
- Pharma Industrypharmaceuticals, biotech, clinical trials, vaccines, FDA approval
- grantsfunding, research grants, government grants, awards, allocations
- R&D fieldsclinical trials, engineering research, materials science, biotech, agricultural research
drug, develop, drugs, development, developing, developed, developer, redevelop, underdeveloped