Your comprehensive resource for pharmaceutical history, regulations, business setup, and global trade.
The Pomodoro Technique
Study for 25 minutes, then take a 5-minute break. After 4 cycles, take a longer break (15-30 mins). This keeps your brain fresh and focused.
Feynman Technique
Try to teach the concept you just learned to a child or a friend. If you get stuck, go back to the source material. Simplification is the ultimate sophistication.
Active Recall
Instead of passively re-reading notes, test yourself. Close the book and try to recite or write down everything you remember.
Mnemonic Devices
Use acronyms, rhymes, or stories to remember complex drug classifications (e.g., “ABCD” for Anti-hypertensives).
Terminology
API
Active Pharmaceutical Ingredient - The biologically active component of a drug product.
GMP
Good Manufacturing Practice - A system for ensuring that products are consistently produced and controlled according to quality standards.
BioavailabilityBioavailability
The proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect.
Pharmacokinetics (PK)
The study of drug absorption, distribution, metabolism, and excretion (ADME).
Pharmacodynamics (PD)
The study of the biochemical and physiologic effects of drugs and their mechanisms of action.
Excipient
An inactive substance that serves as the vehicle or medium for a drug or other active substance.
Placebo
A substance that has no therapeutic effect, used as a control in testing new drugs.
Generic Drug
A medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
Indication
A valid reason to use a certain test, medication, procedure, or surgery.
Contraindication
A specific situation in which a drug, procedure, or surgery should not be used because it may be harmful to the person.
Titration
The process of adjusting the dose of a medication for the maximum benefit without adverse effects.
Half-life
The time required for the amount of drug in the body to decrease by half.
Therapeutic Index
A comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity.
Prophylaxis
Action taken to prevent disease, especially by specified means or against a specified disease.
Parenteral
Administered or occurring elsewhere in the body than the mouth and alimentary canal (e.g., injection).
Bioequivalence
The absence of a significant difference in the rate and extent to which the active ingredient becomes available at the site of drug action.
Validation
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications.
SOP
Standard Operating Procedure - A set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations.
QA & QC
Quality Assurance - The maintenance of a desired level of quality in a service or product.
Quality Control - A system of maintaining standards in manufactured products by testing a sample of the output against the specification.
Quality Control - A system of maintaining standards in manufactured products by testing a sample of the output against the specification.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.
Adulterated Drug
A drug that differs from the standard of strength, quality, or purity that it purports or is represented to possess.
Misbranded Drug
A drug whose label is false or misleading, or does not contain required information.
Shelf-life
The length of time for which a product remains fit for use, consumption, or sale.
Stability Study
Tests to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors.
Dissolution
The process by which a solid substance enters the solvent phase to yield a solution (i.e., mass transfer from solid surface to liquid phase).
Disintegration
The mechanical break up of a compressed tablet into small granules upon ingestion.
Friability
The tendency of a solid substance to break into smaller pieces under duress or contact, especially tablets.
Enteral
Route of administration involving the esophagus, stomach, and small and large intestines (i.e., the gastrointestinal tract).
Sublingual
Route of administration where the drug is placed under the tongue.
Buccal
Route of administration where the drug is placed between the gums and the inner lining of the cheek.
510(k)
Premarket Notification: A submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device.
PMA
Premarket Approval: The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Total Parenteral Nutrition (TPN)
A method of feeding that bypasses the gastrointestinal tract. Fluids are given into a vein to provide most of the nutrients the body needs.
Formulary
A continually updated list of medications and related information, representing the clinical judgment of physicians and pharmacists in the diagnosis and/or treatment of disease and promotion of health.
IV Admixture
The preparation of pharmaceutical product which results in a sterile solution or suspension intended to be administered by injection.
Drug Utilization Review (DUR)
An authorized, structured, ongoing review of prescribing, dispensing and use of medication.
Aseptic Processing
Processing of pharmaceutical products that involves the separate sterilization of the product and of the package and the transfer of the product into the container and its closure under at least ISO 5 conditions.
Lyophilization
Freeze-drying; a dehydration process typically used to preserve a perishable material or make the material more convenient for transport.
Sterility Assurance Level (SAL)
The probability of a single unit being non-sterile after it has been subjected to sterilization.
Bioburden
The number of bacteria living on a surface that has not been sterilized.
Pyrogen
A substance, typically produced by a bacterium, that produces fever when introduced or released into the blood.
Hausner Ratio
A number that is correlated to the flowability of a powder or granular material.
Hygroscopic
A substance that absorbs moisture from the air.
Deliquescent
Substances that absorb moisture from the air until they dissolve and become a solution.
Efflorescent
Substances that lose water of crystallization to the atmosphere.
Terminology
Ophthalmic
Relating to the eye and its diseases; medication applied directly to the eye.
Otic
Relating to the ear; medication applied to or in the ear.
Nebulizer
A device for producing a fine spray of liquid, used for example for inhaling a medicinal drug.
Clinical Trial Phase I
First stage of testing in human subjects (20-100 volunteers), focusing on safety and dosage.
Clinical Trial Phase II
Testing in a larger group of patients (100-300) to assess efficacy and side effects.
Clinical Trial Phase III
Large scale testing (1000-3000+) to confirm efficacy, monitor side effects, and compare to commonly used treatments.
Biobatch
The batch used in a bioavailability or bioequivalence study, or in clinical testing.
Synergism
Interaction of two or more drugs such that their combined effect is greater than the sum of their individual effects.
Potentiation
Interaction where one drug enhances the effect of another drug.
Antagonism
Interaction where one drug inhibits or counteracts the effect of another.
Teratogenicity
The capability of a drug to cause fetal abnormalities when administered to a pregnant woman.
Idiosyncrasy
An abnormal physical reaction by an individual to a food or drug.
Tachyphylaxis
Rapidly diminishing response to successive doses of a drug, rendering it less effective.
Prodrug
A biologically inactive compound which can be metabolized in the body to produce a drug.
First-pass metabolism
The concentration of a drug is greatly reduced before it reaches the systemic circulation.
Emulsion
A fine dispersion of minute droplets of one liquid in another in which it is not soluble or miscible.
Suspension
A heterogeneous mixture containing solid particles sufficiently large for sedimentation.
Elixir
A clear, sweet-flavored liquid used for medicinal purposes, to be taken orally and intended to cure one's illness.
Linctus
A thick liquid medicine, especially a syrup, taken for coughs.
Suppository
A solid medical preparation in a roughly conical or cylindrical shape, designed to be inserted into the rectum or vagina to dissolve.
Pessary
A solid medical preparation designed for insertion into the vagina.
Transdermal Patch
A medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream.
Implant
A small device containing medication that is placed under the skin for slow release.
Liposome
A spherical vesicle having at least one lipid bilayer, used as a vehicle for administration of nutrients and pharmaceutical drugs.
Nanoparticle
A particle of matter that is between 1 and 100 nanometers (nm) in diameter.
Monoclonal Antibodies
Laboratory-made molecules engineered to serve as substitute antibodies that can restore, enhance, or mimic the immune system's attack on cancer cells.
Biosimilar
A biologic medical product highly similar to another already approved biological medicine (the "reference medicine").
Recombinant DNA
DNA molecules formed by laboratory methods of genetic recombination (such as molecular cloning) to bring together genetic material from multiple sources.
Gene Therapy
A technique that modifies a person's genes to treat or cure disease.
Medical Device Class I
Low-risk devices (e.g., bandages, handheld surgical instruments) subject to general controls.
Medical Device Class II
Intermediate-risk devices (e.g., CT scanners, infusion pumps) requiring special controls.
Medical Device Class III
High-risk devices that sustain life or are implanted (e.g., pacemakers), requiring Premarket Approval (PMA).
LAL Test
Limulus Amebocyte Lysate test; an assay used to detect the presence of endotoxins.
Biological Indicator (BI)
A standardized population of microorganisms used to test the effectiveness of a sterilization process.
Endotoxin
A toxin that is present inside a bacterial cell and is released when the cell disintegrates.
Media Fill Test
A microbiological simulation of an aseptic process used to evaluate the sterility of the process.
Autoclave
A machine that uses steam under pressure to kill harmful bacteria, viruses, fungi, and spores on items that are placed inside a pressure vessel.
Capping
A tablet defect where the top or bottom crown of the tablet separates from the main body.
Lamination
A tablet defect characterized by the separation of a tablet into two or more distinct horizontal layers.
Picking
A tablet defect where a small amount of material from a tablet is sticking to and being removed off from the tablet-surface by a punch face.
Sticking
Tablet material adhering to the die wall.
Mottling
Unequal distribution of color on a tablet, with light or dark spots standing out in an otherwise uniform surface.
Angle of Repose
A characteristic related to interparticulate friction or resistance to movement between particles; used to measure flowability of a powder.
Carr's Index
An indication of the compressibility of a powder.
Abbreviations
BID
Bis in die (Twice a day)
Rx
Prescription
QID
Quater in die (Four times a day)
q.s.
Quantum satis (A sufficient quantity)
HS
Hora somni (At bedtime)
PO
Per os (By mouth)
OTC
Over The Counter
IV , IM & SC
IV - IntravenousIntravenous
IM - Intramuscular
SC - Subcutaneous
IM - Intramuscular
SC - Subcutaneous
USFDA, WHO, CDSCO
USFDA - United States Food and Drug Administration
WHO - World Health Organization
CDSCO - Central Drugs Standard Control Organization (India)
WHO - World Health Organization
CDSCO - Central Drugs Standard Control Organization (India)
DCGI , ICH
DCGI - Drug Controller General of India
ICH - International Council for Harmonisation
ICH - International Council for Harmonisation
PRN, NPO, DAW
PRN - Pro Re Nata (As needed)
NPO - Nil Per Os (Nothing by mouth)
DAW - Dispense As Written
NPO - Nil Per Os (Nothing by mouth)
DAW - Dispense As Written
IP, USP, JP, Ph. Eur.,, BP
IP - Indian Pharmacopoeia
USP - United States Pharmacopeia
JP - Japanese Pharmacopoeia
Ph. Eur. - European Pharmacopoeia
BP - British Pharmacopoeia
USP - United States Pharmacopeia
JP - Japanese Pharmacopoeia
Ph. Eur. - European Pharmacopoeia
BP - British Pharmacopoeia
ISO
International Organization for Standardization
rDNA, mAb, PCR
rDNA - Recombinant DNA
mAb - Monoclonal Antibody
PCR -Polymerase Chain Reaction
ELISA - Enzyme-Linked Immunosorbent Assay
mAb - Monoclonal Antibody
PCR -Polymerase Chain Reaction
ELISA - Enzyme-Linked Immunosorbent Assay
ICU, NICU
ICU - Intensive Care Unit
NICU - Neonatal Intensive Care Unit
NICU - Neonatal Intensive Care Unit
Abbreviations
TID
Ter in die (Three times a day)
ANDA , IND, NDA, DMF
ANDA - Abbreviated New Drug Application
IND - Investigational New Drug
NDA - New Drug Application
DMF - Drug Master File
IND - Investigational New Drug
NDA - New Drug Application
DMF - Drug Master File
CAPA
Corrective and Preventive Action
OOS
Out of Specification
OOT
Out of Trend
BMR
Batch Manufacturing Record
BPR
Batch Packaging Record
IQ ,OQ , PQ, DQ
IQ - Installation Qualification
OQ -Operational Qualification
PQ - Performance Qualification
DQ - Design Qualification
OQ -Operational Qualification
PQ - Performance Qualification
DQ - Design Qualification
URS,VMP, SMF, COA, SDS
URS - User Requirement Specification
VMP - Validation Master Plan
SMF - Site Master File
COA - Certificate of Analysis
SDS - Safety Data Sheet (formerly MSDS)
VMP - Validation Master Plan
SMF - Site Master File
COA - Certificate of Analysis
SDS - Safety Data Sheet (formerly MSDS)
PPE, HEPA, LAF, HVAC
PPE - Personal Protective Equipment
HEPA - High Efficiency Particulate Air
LAF - Laminar Air Flow
HVAC - Heating, Ventilation, and Air Conditioning
HEPA - High Efficiency Particulate Air
LAF - Laminar Air Flow
HVAC - Heating, Ventilation, and Air Conditioning
WFI, ALCOA, SOS
WFI - Water for Injection
ALCOA - Attributable, Legible, Contemporaneous, Original, Accurate
SOS - Si Opus Sit (If necessary)
ALCOA - Attributable, Legible, Contemporaneous, Original, Accurate
SOS - Si Opus Sit (If necessary)
AC, PC, AM, PM
AC - Ante Cibum (Before meals)
PC - Post Cibum (After meals)
AM - Ante Meridiem (Before noon)
PM - Post Meridiem (After noon)
PC - Post Cibum (After meals)
AM - Ante Meridiem (Before noon)
PM - Post Meridiem (After noon)
STAT, GTTS
STAT - Statim (Immediately)
GTTS - Guttae (Drops)
GTTS - Guttae (Drops)
OD, OS, OU, AD, AS, AU
OD - Oculus Dexter (Right eye) OR Omni Die
OS - Oculus Sinister (Left eye)
OU - Oculus Uterque (Both eyes)
AD - Auris Dextra (Right ear)
AS - Auris Sinistra (Left ear)
AU -Auris Uterque (Both ears)
OS - Oculus Sinister (Left eye)
OU - Oculus Uterque (Both eyes)
AD - Auris Dextra (Right ear)
AS - Auris Sinistra (Left ear)
AU -Auris Uterque (Both ears)
ADR,ADE
ADR - Adverse Drug Reaction
ADE - Adverse Drug Event
ADE - Adverse Drug Event
Terminology
API
Active Pharmaceutical Ingredient - The biologically active component of a drug product.
Abbreviations
BID
Bis in die (Twice a day)
Clinical Research
- Blood Pressure (Normal) < 120/80 mmHg
- Heart Rate (Resting)60-100 bpm
- Respiratory Rate12-20 breaths/min
- Temperature36.5-37.5 °C (97.7-99.5 °F)
- Fasting Blood Glucose70-99 mg/dL
- HbA1c< 5.7%
- Total Cholesterol< 200 mg/dL
- LDL Cholesterol< 100 mg/dL
- HDL Cholesterol> 40 mg/dL (M), > 50 mg/dL (F)
- Hemoglobin13.5-17.5 g/dL (M), 12-15.5 g/dL (F)
- Serum Creatinine0.7-1.3 mg/dL (M), 0.6-1.1 mg/dL (F)
- Potassium3.5-5.0 mEq/L
- Sodium135-145 mEq/
Clinical Reference Values
-olol Beta-blockers
Ex: Propranolol, Atenolol
Ex: Amoxicillin, Ampicillin
Ex: Atorvastatin, Rosuvastatin
Ex: Omeprazole, Pantoprazole
Ex: Lisinopril, Enalapril
Ex: Losartan, Valsartan
Ex: Amlodipine, Nifedipine
Ex: Ciprofloxacin, Levofloxacin
Ex: Fluconazole, Ketoconazole
Ex: Ranitidine, Famotidine
Ex: Acyclovir, Oseltamivir
Ex: Diazepam, Alprazolam
Pharmaceutical Formulas
Young’s Rule (Child Dose)
(Age in years / (Age + 12)) * Adult DoseClark’s Rule (Child Dose)
(Weight in lbs / 150) * Adult DoseFried’s Rule (Infant Dose)
(Age in months / 150) * Adult DoseBody Mass Index (BMI)
Weight (kg) / Height (m)²Creatinine Clearance (Cockcroft-Gault)
((140 - Age) * Weight (kg)) / (72 * SCr) [x 0.85 if Female]Ideal Body Weight (IBW) – Male
50 kg + 2.3 kg * (Height(in) - 60)Ideal Body Weight (IBW) – Female
45.5 kg + 2.3 kg * (Height(in) - 60)Temperature Conversion (F to C)
(°F - 32) * 5/9Temperature Conversion (C to F)
(°C * 9/5) + 32
