NPC B.Pharm flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Bioavailability formula

Absolute bioavailability F = (AUC oral × Dose IV) / (AUC IV × Dose oral) × 100%. It compares systemic exposure after extravascular administration with intravenous administration.

Beer–Lambert law

Absorbance A = ε × c × l, where ε is molar absorptivity, c is concentration, and l is path length. Valid for dilute solutions and monochromatic light.

Henderson–Hasselbalch equation

For a weak acid, pH = pKa + log([A−]/[HA]). For a weak base, pH = pKa + log([B]/[BH+]). It predicts ionisation and membrane permeability.

Therapeutic index

The ratio of the dose producing toxicity to the dose producing the therapeutic effect. A narrow therapeutic index requires therapeutic drug monitoring to avoid toxicity or treatment failure.

First-pass metabolism

Metabolism of an orally administered drug in the gut wall and liver before reaching systemic circulation. It reduces oral bioavailability and can be avoided by intravenous, sublingual, or transdermal routes.

Zero-order elimination

Elimination at a constant rate independent of plasma concentration, as with ethanol and high-dose phenytoin. Half-life increases with dose and accumulation is unpredictable.

Type A adverse reaction

A dose-dependent, predictable adverse reaction related to the drug's pharmacological action, such as bleeding with anticoagulants. It is usually managed by dose reduction.

Type B adverse reaction

An idiosyncratic, unpredictable adverse reaction unrelated to the drug's pharmacological action, such as anaphylaxis with penicillin. It is often immune-mediated and may require drug withdrawal.

Good Manufacturing Practice

A quality system ensuring products are consistently produced and controlled according to quality standards. It covers personnel, premises, equipment, documentation, production, quality control, and validation.

ICH accelerated stability conditions

Accelerated stability testing is typically conducted at 40°C and 75% relative humidity for six months. It predicts long-term stability and identifies degradation pathways.

Class I recall

A recall of a product likely to cause serious harm or death. It requires immediate action and public notification to protect patient safety.

Validation lifecycle

A sequence of design qualification, installation qualification, operational qualification, performance qualification, and ongoing process verification. It demonstrates that a process consistently meets specifications.

Biopharmaceutics Classification System

A system classifying drugs by solubility and permeability: Class I high/high, Class II low solubility/high permeability, Class III high solubility/low permeability, Class IV low/low. It guides dissolution testing and formulation.

Stokes' law

Sedimentation velocity v = 2r²(ρp − ρf)g / 9η, where r is particle radius, ρ is density, g is gravity, and η is viscosity. It predicts suspension settling and guides particle size control.

Sterility assurance level

The probability of a single viable microorganism surviving sterilisation, typically 10⁻⁶ for sterile products. It is achieved through validated terminal sterilisation or aseptic processing.

Friability test

A tablet quality test measuring weight loss after tumbling in a friabilator. Weight loss of no more than 1% is generally acceptable for uncoated tablets.

Noyes–Whitney equation

Dissolution rate dC/dt = (D × A × (Cs − C)) / (h × V), where D is diffusion coefficient, A is surface area, Cs is saturation solubility, h is diffusion layer thickness, and V is volume.

Clearance formula

Clearance CL = Dose / AUC, representing the volume of plasma cleared of drug per unit time. It determines the maintenance dose rate required to achieve a target concentration.

Volume of distribution

Vd = Dose / C0, the apparent volume relating the amount of drug in the body to its plasma concentration. It influences loading dose and half-life.

Cockcroft–Gault equation

Creatinine clearance = [(140 − age) × weight] / (72 × serum creatinine), multiplied by 0.85 for females. It guides renal dose adjustment.

Warfarin monitoring

Warfarin inhibits vitamin K epoxide reductase and is monitored by INR. CYP2C9 and VKORC1 variants affect dose requirements and bleeding risk.

Heparin monitoring

Heparin enhances antithrombin III activity and is monitored by aPTT. Protamine sulfate reverses heparin; vitamin K reverses warfarin.

Metformin first-line therapy

Metformin is first-line for type 2 diabetes, reducing hepatic glucose production. It is contraindicated in severe renal impairment due to lactic acidosis risk.

ACE inhibitor contraindications

ACE inhibitors are contraindicated in pregnancy, bilateral renal artery stenosis, and history of angioedema. They cause hyperkalaemia and reduce glomerular filtration.

CYP450 inhibition

Inhibition of cytochrome P450 enzymes increases plasma levels of substrate drugs, raising toxicity risk. Examples include macrolides and azole antifungals.

CYP450 induction

Induction of cytochrome P450 enzymes decreases plasma levels of substrate drugs, reducing efficacy. Examples include rifampicin and carbamazepine.

Pharmacovigilance reporting

Serious adverse drug reactions must be reported to the national pharmacovigilance centre within 15 days. Causality is assessed using WHO-UMC criteria.

Controlled drugs register

A dedicated register recording receipts, supplies, and destruction of controlled drugs. Entries must be contemporaneous, legible, and retained for the statutory period.

Prescription requirements

A valid prescription includes patient name, date, drug name, strength, dosage form, quantity, directions, and prescriber signature. The pharmacist verifies legality and clinical appropriateness.

Pharmacist registration categories

Categories include full, provisional or intern, and temporary registration. Each defines scope of practice and conditions for renewal.

Professional misconduct

Conduct falling below the standards expected of a registered pharmacist, including negligence, dishonesty, or practising while impaired. It may result in suspension or removal from the register.

Quality by Design

A systematic approach identifying critical quality attributes and critical process parameters to define a design space. It improves process robustness and product quality.