Clinical Resources — TheraCALC

External links open in a new tab. TheraCALC links only to publicly available government, institutional, peer-reviewed sources, and indexes. These are reference resources — always verify against your institution's formulary and protocols.

💊 Drug Labeling & Prescribing Information FDA-approved sources

NIH / NLM — FDA Drug Labeling Database

Opens DailyMed (NIH/NLM) in a new tab — current FDA-approved labeling, dosing, and renal adjustment information.

Pharmacist's Letter

pharmacist.therapeuticresearch.com

Medications That Should Not Be Crushed ↗

Reference list of oral solid dosage forms that cannot be safely crushed — extended-release, enteric-coated, sublingual, and hazardous formulations. May require institutional or subscription access.

Drug Administration

crediblemeds.org

QTDrugs List — Drug Safety Database↗

AZCERT/CredibleMeds database of drugs with known, conditional, or possible risk of QT prolongation and Torsades de Pointes. Essential reference for arrhythmia risk screening in polypharmacy patients.

Official FDA National Drug Code directory. Search by proprietary name, non-proprietary name, labeler, or NDC number. Updated daily.

accessdata.fda.gov

FDA drug approvals, labels, and approval history. Useful for checking REMS, biosimilars, and NDA/ANDA status.

accessdata.fda.gov

FDA Drug Safety Communications↗

Safety alerts, black box warning updates, and risk communications for marketed drugs.

ISMP High-Alert Medications — Acute Care↗

Institute for Safe Medication Practices list of high-alert drugs with the greatest risk of harm when misused.

Renal Function & Dosing Guidance FDA & KDIGO

FDA 2024 — Pharmacokinetics in Renal Impairment↗

Guidance for industry on PK studies in patients with impaired renal function. Basis for eGFR-first dosing in TheraCALC.

KDIGO 2024 — CKD Evaluation & Management↗

International CKD staging, eGFR thresholds, and dosing category definitions. Reference for the renal dosing tiers in TheraCALC.

CKD-EPI 2021 Equation↗

Race-free CKD-EPI creatinine equation (2021). Used as the primary eGFR-Cr estimate in TheraCALC's renal driver panel.

Cockcroft-Gault — Original 1976 Paper↗

Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976. Primary source for the C-G CrCl equation.

Primary Literature

🧪 Vancomycin — Guidelines & PK Literature AUC-guided dosing

ASHP/IDSA/SIDP 2020 Vancomycin Consensus Guidelines↗

The canonical guideline establishing AUC/MIC-guided monitoring (target AUC 400–600 mg·h/L) as the standard of care. Basis for TheraCALC's AUC targets.

Consensus Guideline

Fewel et al. 2021 — Trough-Only AUC Estimation↗

Fewel N. J Clin Pharm Ther. 2021;46(5):1426–1432. The derivation of the trough-only AUC estimation method, showing that standard pharmacokinetic equations can estimate vancomycin AUC from steady-state trough concentrations alone.

Validation Study

Matzke et al. 1984 — Vancomycin PK↗

Matzke GR et al. Antimicrob Agents Chemother 1984;25(3):433–437. Original vancomycin CLv–CrCl regression (0.689×CrCl + 3.66) in 56 patients across a spectrum of renal function.

Primary Literature

🧫 Aminoglycosides — Guidelines & PK Literature Extended-interval & obesity dosing

Nicolau et al. 1995 — Hartford Once-Daily Program↗

Nicolau DP et al. Antimicrob Agents Chemother 1995;39(3):650–655. The original 2,184-patient once-daily program: fixed 7 mg/kg, CrCl-based starting interval, and the monitoring nomogram (single random level, 6–14 h; borderline levels → longer interval). Basis for TheraCALC's extended-interval path + Hartford nomogram.

Primary Literature

Smit et al. 2019 — Gentamicin PK in Morbid Obesity↗

Smit C et al. Clin Pharmacokinet 2019;58(10):1333–1343. Prospective obesity PK: clearance and central volume both weight-dependent, but the clearance exponent (0.73) is lower than the volume exponent (1.25) — clearance is the less weight-dependent of the two. Supports the smaller weight-adjustment on the clearance side.

Primary Literature

Smit et al. 2020 — Gentamicin Dosing in Obesity↗

Smit C et al. J Antimicrob Chemother 2020;75(11):3286–3292 (open access). Real-world dose recommendations across body weight and renal function; clearance driven primarily by renal function.

Primary Literature

Pai et al. 2011 — AG PK in Underweight & Obese Adults↗

Pai MP, Nafziger AN, Bertino JS. Antimicrob Agents Chemother 2011;55(9):4006–4011. Clearance best predicted by renal function, not total body weight — supporting a conservative weight-adjustment on the Cockcroft-Gault side.

Primary Literature

Märtson et al. 2025 — Antibiotic Dosing in Obesity↗

Märtson A-G et al. Lancet Infect Dis 2025;25(9). Systematic review + international consensus guidelines for antibiotic dose adjustment in obesity (>120 PK studies).

Consensus Review

⚗️ Acid-Base & Critical Care ABG interpretation

Jansen et al. 2010 — Lactate Clearance↗

Jansen TC et al. Am J Respir Crit Care Med. 2010;182(6):752–761. Lactate trajectory thresholds underpinning the TheraCALC lactate clearance flags in the acid-base calculator.

Primary Literature

StatPearls — Arterial Blood Gas Interpretation↗

Free, peer-reviewed ABG interpretation reference from NCBI StatPearls. Covers step-by-step approach consistent with TheraCALC's acid-base logic.

ncbi.nlm.nih.gov

ACP Clinical Guidelines↗

American College of Physicians clinical practice guidelines including internal medicine and critical care topics.

🩸 Anticoagulation — Guidelines & Clinical References MAQI2 · ACC/AHA · CHEST · ASRA · ASH

ACC/AHA/ACCP/HRS 2023 AFib Guidelines↗

2023 ACC/AHA/ACCP/HRS Guideline for Diagnosis and Management of Atrial Fibrillation. CHA₂DS₂-VASc scoring, anticoagulation selection, and stroke prevention recommendations.

CHEST 2022 — Antithrombotic Therapy↗

American College of Chest Physicians antithrombotic guidelines. VTE treatment, periprocedural management, and bridging recommendations.

PAUSE Trial — DOAC Periop Interruption↗

Douketis et al., JAMA Intern Med 2019. Standardized DOAC interruption without heparin bridging for elective procedures. Foundation for TheraCALC DOAC hold calendar logic.

ASRA 2025 — Neuraxial & Deep Block Guidelines↗

American Society of Regional Anesthesia guidelines for anticoagulant management in patients receiving neuraxial or deep peripheral nerve blocks. DOAC and heparin hold times. Fifth edition (Kopp et al., Reg Anesth Pain Med 2025).

pubmed.ncbi.nlm.nih.gov

ASH Guidelines — Heparin-Induced Thrombocytopenia↗

American Society of Hematology 2018 HIT guidelines (Cuker et al., Blood Adv 2018). 4T score interpretation, direct thrombin inhibitor selection, and management of suspected or confirmed HIT.

pubmed.ncbi.nlm.nih.gov

MAQI2 Anticoagulation Toolkit↗

Michigan Anticoagulation Quality Improvement Initiative. Clinical decision-support tools for warfarin dosing, DOAC management, periprocedural interruption, and HIT. Primary reference source for TheraCALC anticoagulation content.

anticoagulationtoolkit.org

Clinical Toolkit

💊 Pain Management & Opioids — Guidelines & Clinical References CDC · FDA · APS · ASHP

CDC 2022 Clinical Practice Guideline — Prescribing Opioids for Pain↗

Dowell D, Ragan KR, Jones CM, et al. MMWR Recomm Rep 2022;71(3):1–95. The primary framework for the toolkit: MME thresholds, initiation & titration, naloxone co-prescribing, breakthrough dosing, and risk mitigation. DOI 10.15585/mmwr.rr7103a1.

CDC — Calculating Total Daily Dose (MME)↗

CDC conversion factors used in the MME calculator and the equianalgesic quick table. Notes the analytic intent of MME and the exclusion of parenteral fentanyl, methadone, and buprenorphine from straightforward conversion.

cdc.gov/overdose-prevention

VA/DoD — Opioid Therapy for Chronic Pain CPG↗

Department of Veterans Affairs / Department of Defense clinical practice guideline. Risk stratification, tapering, and monitoring recommendations referenced in the Learn algorithm and risk sections.

healthquality.va.gov

Methadone Safety CPG (APS / CPDD / HRS)↗

Chou R, Cruciani RA, Fiellin DA, et al. J Pain 2014;15(4):321–337. Basis for the methadone pearls: dose-dependent conversion ratios, QTc/ECG monitoring, and "start low, go slow" titration. DOI 10.1016/j.jpain.2014.01.494.

pubmed.ncbi.nlm.nih.gov

McPherson — Demystifying Opioid Conversion Calculations (ASHP)↗

McPherson ML. ASHP, 2nd ed. 2018. Source for the PCA starting parameters (demand, loading, lockout, continuous ranges) and the rotation/cross-tolerance methodology used throughout the toolkit.

FDA Prescribing Information (DailyMed)↗

Official FDA labeling for Belbuca, Butrans, OxyContin, Exalgo, Duragesic, and others. Source for buprenorphine taper-to-≤30-MME conversion, ER dosing intervals, opioid-tolerant definitions, and dispensable strengths.

dailymed.nlm.nih.gov

Opioid Risk Tool (ORT) — Webster 2005↗

Webster LR, Webster RM. Pain Med 2005;6(6):432–442. Sex-weighted OUD risk screening instrument reproduced in the Risk & Safety section. DOI 10.1111/j.1526-4637.2005.00072.x.

pubmed.ncbi.nlm.nih.gov

WHO Guidelines — Cancer Pain & Analgesic Ladder↗

World Health Organization guidelines for the pharmacological management of cancer pain. Basis for the three-step analgesic ladder and adjuvant/co-analgesic guidance in the Learn algorithm.

StatPearls — Opioid Equivalency↗

Peer-reviewed open reference (NCBI Bookshelf) on equianalgesic conversion and incomplete cross-tolerance. Supports the rotation reduction logic and IV→PO breakthrough sizing.

ncbi.nlm.nih.gov/books

Opioid Toolkit — verification provenance. The toolkit's calculations and clinical content are source-checked against the references above — conversion factors against the CDC 2022 CPG, FDA-label values against current prescribing information, and the ORT, methadone, and rotation guidance against their primary sources. Verification confirms each value matches an authoritative source; it does not certify safety for an individual patient, and guidelines and labels change — confirm against current sources before clinical use.

🛡️ Regulatory & Medication Safety FDA · ISMP · MedWatch

FDA MedWatch↗

Report and track adverse drug events, medication errors, and safety issues to the FDA.

fda.gov/safety/medwatch

ISMP — Medication Safety↗

Institute for Safe Medication Practices. Alerts, error reports, and best practices for medication safety.

CDC Antibiotic Stewardship↗

CDC resources for inpatient antibiotic stewardship programs. Core stewardship principles, implementation guides, and tracking tools.

📄 TheraCALC Documentation & Methodology Internal · Proprietary

eGFR · CrCl · Cystatin C — Renal Dosing Guide

When CrCl, eGFRcr, and eGFRcr–cys disagree: which estimate to dose by, de-indexing, obesity/sarcopenia/AKI scenarios, and worked examples.

Vancomycin AUC — Methodology & Validation

PK models, CLv equations, Vd selection, loading dose logic, and trough-only AUC method.

Acid-Base — Methodology & Validation

Compensation formulas, anion gap, delta-delta, UAG, lactate trajectory, and clinical preset logic.

Acid-Base — Safety & Governance

Clinical positioning, intended use, known limitations, and safety governance for the acid-base calculator.

Privacy & Data Protection Notice

Data handling, HIPAA context, no patient data storage policy, and privacy practices.