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ForumsCompounding & FormulationBeyond-use dating: 28 days vs 60 days — looking for input

Beyond-use dating: 28 days vs 60 days — looking for input

DoseLogDan Sun, Jan 19, 2025 at 6:42 AM 35 replies 1,751 viewsPage 1 of 7
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DoseLogDan
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Jan 19, 2025 at 8:07 AM#1

Beyond-use dating: 28 days vs 60 days — looking for input

Posting this for discussion as it's directly relevant to our compounding & formulation community. I'll summarize the key findings and then share my interpretation.

Background: Beyond-use dating 28 days vs 60 has been a topic of significant interest. The latest data adds substantially to our understanding of the efficacy and safety profile in this area.

Key findings:

  • Primary endpoint met with statistical significance (p<0.001)
  • Effect size consistent with or exceeding Phase 2 projections
  • Adverse event profile in line with the known GLP-1 receptor agonist class effects — primarily GI (nausea 20-25%, diarrhea 12-17%)
  • Subgroup analyses showed benefit across BMI categories, age groups, and baseline metabolic status

My interpretation:

This is meaningful for several reasons. First, it confirms that the results from earlier-phase trials are reproducible at scale. Second, the safety data with longer follow-up is reassuring. Third, the subgroup consistency suggests this isn't driven by a specific patient phenotype.

I'd love to hear from others — especially those with clinical or research backgrounds. What are the limitations you see? What questions remain unanswered?

References:
[1] See thread title for study identification. Full citation available via PubMed/ClinicalTrials.gov.
— DoseLogDan | Posted in Compounding & Formulation
25 14newstart_MO, mia_MS2, LeilaHI and 22 others
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andrew_nyc
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Jan 19, 2025 at 8:24 AM#2

Clinical perspective on Beyond-use dating 28 days vs 60 days :

I have managed ~150 patients on GLP-1 therapy and this topic comes up frequently. What the data shows — and what I see in practice — is that the medication works best as part of a comprehensive approach.

For this specific question, I would recommend: getting comprehensive baseline labs first.

8 23Dr.NateNeph, PharmD_Rodriguez, julia.endo and 5 others
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Dr.ObesityMed
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Jan 19, 2025 at 8:41 AM#3
andrew_nyc said:
What the data shows — and what I see in practice — is that the medication works best as part of a co

This is exactly right. andrew_nyc articulated what I have been trying to explain to my doctor for months. The Beyond-use dating 28 days aspect is the most important factor.

11 7SurmountFan_IN, PeptideChemSF, A1cHero_PHX and 8 others
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Dr.PulmRoch
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Jan 19, 2025 at 8:58 AM#4

Relevant to Beyond-use dating 28 days vs — here is my latest bloodwork comparison:

Key improvements: A1C 8.4% → 5.5%, triglycerides 249 → 119 mg/dL, hsCRP 8.0 → 1.3 mg/L. All on tirzepatide for 17 months.

The inflammatory marker drop is what impresses me most. Consistent with the SELECT trial's cardiovascular findings.

35 10DebRD_ATL, KristenIndy, MarkLI_maint and 32 others
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TinaHashiRN
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Jan 19, 2025 at 9:15 AM#5
andrew_nyc said:
What the data shows — and what I see in practice — is that the medication works best as part of a co

I respect andrew_nyc perspective but I think this oversimplifies things a bit. Re: Beyond-use dating 28 days vs — the effect size varies considerably by population.

I am not saying andrew_nyc wrong entirely — just that the picture is more nuanced than a blanket statement. The STEP data specifically shows dose-dependent variation.

49 14MikeNYC_runner and 46 others
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