A quality control method enhancement concept—Continual improvement of regulatory approved QC methods

Åsberg, Dennis; Nilsson, Mikael; Olsson, Susanne; Samuelsson, Jörgen; Svensson, Olof; Klick, Silke; Ennis, Julie; Butterworth, Paul; Watt, Denise; Iliadou, Stavroula; Karlsson, Angelica; Walker, Joanne T.; Arnot, Kate; Ealer, Norb; Hernqvist, Kerstin; Svensson, Karin; Grinell, Ali; Quist, Per‐Ola; Fornstedt, Torgny

doi:10.1016/j.jpba.2016.06.018

Cited by 22 publications

(14 citation statements)

References 17 publications

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“…The results of these observations using spectrophotometer UV-visible showed that the wavelength selected was 223 nm. That wavelength was not intervening to other compounds, and some researchers have already used that wavelength to identify clenbuterol by HPLC in plasma [ 19 ]. An analysis with HPLC showed the retention time of clenbuterol from the injection dose regimen was found to be approximately ±12 min (Figures- 1 and 2 ).…”

Section: Resultsmentioning

confidence: 99%

“…We found that the retention time chromatogram of the analyte was available for 11-12 min as shown in Figure-1 . The chromatogram of the analyte from the goats was never overlayid with other impurity peaks from the biology matrix of the biology compound [ 19 , 20 ]. Figure-2 shows that impurity peaks at more than 12 min until the stop time at 35 min were not found.…”

Section: Discussionmentioning

confidence: 99%

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Calculate of withdrawal times of clenbuterol in goats to obtain safe times of slaughter

Lazuardi¹,

Hermanto²,

Restiadi³

2018

Vet World

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Background and Aim:Clenbuterol as a β2-agonist drug was investigated according to the concentration of the drug available in the bodies of goats and according to the level of sensitivity of the instruments used for detection. The objective of the current study was to determine withdrawal times after giving a therapeutic dose that resulted in safe slaughters.Materials and Methods:Five healthy male goats with a mean body weight of 20.64 kg were treated with a single dose of 5.10−3 mg/kg in the BW onto jugular vein. Whole blood samples of approximately 5 mL were taken in a time series at 5, 30, 60, 90, 150, 210, 270, 390, 510, 630, and 750 min. At 24 h posttreatment, all subjects were sacrificed, and 300 g samples of the liver were obtained. The plasma concentration and liver residue of the drug were observed by reverse-phase high-performance liquid chromatography.Results:The drug reached a maximum concentration of 19.233±0.331 µg/mL at 5 min, and the elimination half-life was at 173.25 min. The limit detection was obtained at 0.053 µg/mL. A one-way analysis of variance between all goats showed that elimination of the clenbuterol in their bodies was similar (p=1.00), with a withdrawal time of 1,479.326 min and no residues in the liver (p<0.05).Conclusion:Safe times for slaughter were determined to be at 2 days, 13 h, and 12 min as the 2nd safety factor (SF) time and 3 days, 1 h, and 58 min as the 3rd SF time with the liver organ free from residue.elimination half-life, new method for calculating withdrawal time, prescriptions for obtained β2-agonist, residues in liver.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Calculate of withdrawal times of clenbuterol in goats to obtain safe times of slaughter

Lazuardi¹,

Hermanto²,

Restiadi³

2018

Vet World

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“…New equipment and improved techniques are constantly being developed, increasing the possibilities for fast and precise QC methods. Continuous improvement of already approved QC methods is therefore essential in order to keep up to date with the fast‐changing environment . Two examples of such newly available technologies are core‐shell columns and UHPLC equipment.…”

Section: Introductionmentioning

confidence: 99%

“…By applying the principles of establishing a design space and a control strategy as part of the method development process, a deeper scientific knowledge can be gained and thereby enable an increased regulatory flexibility . Furthermore, it has been suggested that, since QC testing only begins after a successful control in the form of a System Suitability Test, it should be possible to move outside the established design space as long as the method performance is confirmed by the System Suitability Test . Although it might not be the current regulatory approach, these ideas are supported by the concepts outlined in the draft version of ICH Q12 .…”

Section: Introductionmentioning

confidence: 99%

Ultra high performance liquid chromatography method development for separation of omeprazole and related substances on core‐shell columns using a Quality by Design approach

Johansson

Ludvigsson

2019

J of Separation Science

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An updated and improved method for analysis of omeprazole/esomeprazole and related substances on core‐shell columns was developed using Fusion LC Method Development™. The method was optimized with respect to column type, column temperature, mobile phase pH level, and gradient time. Four different core‐shell columns were examined to develop a method suitable for both high performance‐ and ultra‐high performance liquid chromatography using a Quality by Design approach. The final method offers two alternative columns: Poroshell EC C18 (3.0 × 100 mm, 2.7 µm) or Poroshell HPH (3.0 × 100 mm, 2.7 µm) with the same gradient elution condition and mobile phase composition. Total run time is 18 min with 12 min of gradient elution. Phosphate buffer (15 mM, pH 7.8) is selected as the aqueous mobile phase and acetonitrile as the organic mobile phase. Column temperature is set at 40°C and ultraviolet detection at 302 nm. Furthermore, by studying parameters in a systematic way, an understanding of the effect of the input parameters enhances the method robustness and should allow for regulatory flexibility in terms of post‐approval changes. Compared to the current United States Pharmacopeia method, the updated method is faster, more efficient and performs well above acceptance criteria.

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“…Biological medicines, such as peptides, proteins, mRNA, oligonucleotides, vaccines, and plasmids, − are a strongly growing area of importance for the pharmaceutical industry. , Reliable analysis of biomolecular interactions is crucial in order to fulfill modern drug quality assurance criteria, both for traditional small API molecules and for next-generation biological drugs. Therefore, there has been an accelerated technological development of biosensor instruments based on, among others, surface plasmon resonance (SPR) and quartz crystal microbalance (QCM). − …”

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confidence: 99%

Reliable Strategy for Analysis of Complex Biosensor Data

et al. 2018

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When using biosensors, analyte biomolecules of several different concentrations are percolated over a chip with immobilized ligand molecules that form complexes with analytes. However, in many cases of biological interest, e.g., in antibody interactions, complex formation steady-state is not reached. The data measured are so-called sensorgram, one for each analyte concentration, with total complex concentration vs time. Here we present a new four-step strategy for more reliable processing of this complex kinetic binding data and compare it with the standard global fitting procedure. In our strategy, we first calculate a dissociation graph to reveal if there are any heterogeneous interactions. Thereafter, a new numerical algorithm, AIDA, is used to get the number of different complex formation reactions for each analyte concentration level. This information is then used to estimate the corresponding complex formation rate constants by fitting to the measured sensorgram one by one. Finally, all estimated rate constants are plotted and clustered, where each cluster represents a complex formation. Synthetic and experimental data obtained from three different QCM biosensor experimental systems having fast (close to steady-state), moderate, and slow kinetics (far from steady-state) were evaluated using the four-step strategy and standard global fitting. The new strategy allowed us to more reliably estimate the number of different complex formations, especially for cases of complex and slow dissociation kinetics. Moreover, the new strategy proved to be more robust as it enables one to handle system drift, i.e., data from biosensor chips that deteriorate over time.

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A quality control method enhancement concept—Continual improvement of regulatory approved QC methods

Cited by 22 publications

References 17 publications

Calculate of withdrawal times of clenbuterol in goats to obtain safe times of slaughter

Calculate of withdrawal times of clenbuterol in goats to obtain safe times of slaughter

Ultra high performance liquid chromatography method development for separation of omeprazole and related substances on core‐shell columns using a Quality by Design approach

Reliable Strategy for Analysis of Complex Biosensor Data

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