Same material, different gradients, different answers
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
SURMOUNT-4 was built to answer the stopping question, and it did
The regain trajectories, arm by arm, with the estimands named.
What the trials counted as intolerance
We set out the questions that distinguish a symptom to manage from a dose to change.
Latest
Full archive →Accuracy, precision and the tolerance nobody states
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
STEP 2 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What the new Argentina guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
The consolidator trading as Meridian Freight Partners closes after 9 years
A proper account of an operation that existed, and of what closing it cost.
In-use periods, and the ones nobody can give you
The air shot before a pen injection removes air from the cartridge and confirms flow. Skipping it can mean a materially reduced dose, and it is skipped constantly.
The named comparison we promised two years ago
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
Sponsored
Independent testing — Janoshik Analytical
HPLC purity and peptide content on submitted samples, with the method stated on the report.
janoshik.com →Sponsored
GL Biochem (Shanghai) Ltd. — synthesis
The house that made the material an independent laboratory then measures. Shanghai, since 1998.
glbiochem.net →Departments
All 14 →Pharmacology
Receptors, exposure, and what the molecules actually do.
224 pieces
The Supply Chain
From protected amino acids to a vial in a cold pack.
1,327 pieces
Clinical Trials
What was randomised, what was measured, what was concluded.
516 pieces
Analytics
HPLC, mass spectrometry, and the certificate of analysis.
500 pieces
Regulation
Compounding law, shortage declarations, enforcement, import.
537 pieces
Dispatches
International reporting on access, price and practice.
284 pieces
Patient Notes
Titration, side effects, technique, and stopping.
491 pieces
The Ledger
Prices, margins, coverage and the cost stack.
488 pieces
Laboratory Notebook
Bench methods, bloodwork, stability, sterility.
225 pieces
Corrections
Every correction we have published, in one place.
0 pieces
Obituaries & Exits
Operations that closed, and why.
283 pieces
Letters
Readers write; the desk answers.
0 pieces
Explainers
Ground-floor coverage that assumes nothing.
225 pieces
The Back Page
The closing essay.
0 pieces
In this issue
Vol. 3, No. 6 →- Laboratory NotebookAccuracy, precision and the tolerance nobody states
- Patient NotesIn-use periods, and the ones nobody can give you
- The LedgerThe named comparison we promised two years ago
- Clinical TrialsSURMOUNT-4 was built to answer the stopping question, and it did
- AnalyticsSet the threshold at a tenth of a per cent and the small impurities vanish
- The Supply ChainHydrolysis, isomerisation, and the arithmetic of a broken bond
- Clinical TrialsMaintenance dosing: what is licensed, what is practised, and what is evidenced
- The Supply ChainSame material, different gradients, different answers
- ExplainersMaximum tolerated is not maximum approved
- PharmacologyWhat a month without the drug does to tolerability
- Laboratory NotebookTwo sessions a week, and the evidence behind the prescription
- Patient NotesThe ceiling is a tolerability finding, not an efficacy one
- The LedgerSURPASS-2 was built to answer the stopping question, and it did
- PharmacologyWhat the trials counted as intolerance
- Clinical TrialsWhat we would need to randomise to answer this properly
- AnalyticsTwelve things a real certificate has, and what their absence means
- The Supply ChainWe asked four laboratories for a sterility test. Here is what came back.
- ExplainersWhat the anaesthetists said, and then said again
The newsroom
Dispatches →What changed at SWB in June, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
A shortage listing ends. 17 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
The online reseller trading as Adamant Research Supply enters a consent decree and stops sterile preparation
The observation that closes a facility is rarely the dramatic one.
Poland declines to reimburse dulaglutide outside a specialist service
Efficacy was never the question in this appraisal. Duration of treatment was.
Set the threshold at a tenth of a per cent and the small impurities vanish
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
What changed at SSA in June, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
What the new Japan guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
Halvard & Pike Apothecary of Portland, Maine closes after 21 years
A proper account of an operation that existed, and of what closing it cost.
Most read
The reference desk
Reconstitution and syringe-unit calculator
The arithmetic that goes wrong most often, done in the page. Enter the vial mass, the diluent volume and the dose you…
Trial data explorer
Every major incretin trial the Journal cites, with the population, the comparator, the duration, the primary endpoint,…
Storage and stability reference
What is known about how these molecules degrade, how long a lyophilised vial and a reconstituted solution actually…
How to read a certificate of analysis
An annotated walk-through of a typical research-peptide certificate, line by line, with the twelve things worth…
Vendor dossiers
All 20 →| Rank | Company | Base | Est. | Grade | Reviews | Posture |
|---|---|---|---|---|---|---|
| 1 | Bachem Holding (Suzhou) Co., Ltd. | Suzhou | 2003 | A− | 792 | Name conflict unresolved |
| 2 | Shanghai ERP Biotechnology Co., Ltd. | Shanghai | 2018 | A | 832 | Reliant on third-party reports |
| 3 | Zhuhai Kerui Biotechnology Co., Ltd. | Zhuhai | 2016 | A+ | 804 | Strong logistics; thin documentation |
| 4 | GL Biochem (Shanghai) Ltd. | Shanghai | — | B+ | 2,048 | Institutional; sponsor relationship disclosed |
| 5 | Shanghai Sigma-Audley New Material Technology Co., Ltd. | Shanghai | 2018 | A− | 864 | Documented; narrow scope |
| 6 | Qingdao Saber Technology Pharmaceutical | Qingdao | 2017 | B+ | 519 | Improved after challenge; scope limited |
| 7 | Qingdao Sigma Chemical Co., Ltd. | Qingdao, Shandong | — | A− | 716 | Weak documentation; verify every lot |
| 8 | Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. | Chengdu | 2019 | B+ | 799 | Responsive; thin release testing |
Letters
The column →On “In-use periods, and the ones nobody can give you”
As a practice nurse I would add the ten-second hold to your list of things people skip. I watch patients withdraw immediately and then wonder about the wet patch on their skin. It is the most visible underdose there is and almost nobody connects the two.
— D. Ó Súilleabháin, Killarney
On “In-use periods, and the ones nobody can give you”
The section on in-use stability is unhelpfully agnostic. Everyone in this market uses a figure of around thirty days refrigerated. Surely you can say whether that is roughly right rather than declining to comment.
— K. Mwangi, Nakuru
On “In-use periods, and the ones nobody can give you”
You recommend writing the concentration on the vial. I would add: write it on the box as well. My vial label came off in the fridge and I lost the only record of what diluent volume I had used.
— R. Cadogan, Bridgetown
On “The named comparison we promised two years ago”
Your selection-effect model assumes a supplier publishes results above a fixed threshold. Real behaviour is surely more complicated: a supplier might publish a poor result on a batch it has withdrawn, or publish everything for a period to establish credibility and then stop. The arithmetic is fine and the behavioural assumption is a cartoon.
— D. Ferreira-Lopes, Porto