PUB-001
From compounding to formulation design
A laboratory translates a confirmed therapeutic need into a controlled process. Dosage form, compatibility and evidence must agree before compounding.
Read and PDF →QUALITY / EVIDENCE
Educational technical reviews
17 bilingual documents in this edition.
PUB-002
Ten potential compounding failure mechanisms
This review considers ten potential mechanisms. It does not rank them by frequency because no incident dataset with a denominator supports such a ranking.
Read and PDF →PUB-003
Compounding documentation with controlled records
Repeatable preparation requires identifiable instructions and a complete actual record. Documentation links decisions to evidence and batches to recipients.
Read and PDF →PUB-004
From an unmet need to a development plan
Pharmacy experience can generate useful research questions. Product value, technical feasibility and regulatory route then require separate assessment.
Read and PDF →PUB-005
Ingredient and finished-preparation compatibility
The finished matrix is the object of assessment. Suitable individual materials or commercial products do not alone establish suitability of their combination.
Read and PDF →PUB-006
Stability rationale in pharmacy compounding
Dating is justified for a particular formula, package and conditions. Separate source instructions, experimental data and the default selected for the batch.
Read and PDF →PUB-007
Choosing a dosage form
Select dosage form consistently with prescribing and actual administration needs. Changing route or release type is not a simple technical adjustment.
Read and PDF →PUB-008
Lessons from compounding for product development
Knowledge of daily use helps define specifications. Using it requires systematic records and testing; it does not automatically establish successful scaling or clinical benefit.
Read and PDF →PUB-009
Assessing a case as a research opportunity
This note turns a professional observation into a testable question. Savings, adherence and efficacy claims need corresponding evidence.
Read and PDF →PUB-010
Written procedures for nonsterile compounding
This updated text links procedure, responsibility and evidence. Collection SOPs need named local approval, suitable equipment and training before use.
Read and PDF →PUB-011
Compounding records and traceability
This updated text accompanies F-001 through F-021. Sources and signatures must allow retrospective review of actual product, materials and handover.
Read and PDF →PUB-012
Compounding service in dermatological care
Individualisation may address a specific dosage-form or ingredient problem. It does not imply universal superiority, lower cost or absence of allergies. Development formulas need their own evidence before becoming compounding instructions.
Read and PDF →PUB-013
Practical BUD selection and documentation
A day count needs an applicable category, temperature and specific limitations. This text covers nonsterile preparations; its limits are not transferred to sterile or allergen products without appropriate assessment.
Read and PDF →PUB-014
Water activity and interpretation
Water activity describes water availability in the actual matrix. A reliable decision requires a suitable method and representative sample.
Read and PDF →PUB-015
Allergen preparations and quality evidence
Clinical immunotherapy evidence and quality of a specific laboratory preparation are separate questions. Collection dossiers maintain that distinction.
Read and PDF →PUB-016
Clinical excipient assessment and daily exposure
Excipient safety depends on actual quantity, route and patient. This review links calculation to current evidence and clinical decisions.
Read and PDF →PUB-017
Analytical testing and actual delivered dose
No single test answers every quality question. The strategy selects which attribute needs evidence, by which method and at which stage.
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