| 1. |
- Åsberg, Dennis, 1988-, et al.
(författare)
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A quality control method enhancement concept : Continual improvement of regulatory approved QC methods
- 2016
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Ingår i: Journal of Pharmaceutical and Biomedical Analysis. - : Elsevier. - 0731-7085 .- 1873-264X. ; 129, s. 273-281
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Tidskriftsartikel (refereegranskat)abstract
- Quality Control methods (QC-methods) play an important role in the overall control strategy for drug manufacturing. However, efficient life-cycle management and continual improvement are hindered due to a variety of post-approval variation legislations across territories and a lack of harmonization of the requirements. As a result, many QC-methods fall behind the technical development. Developing the QC-method in accordance with the Quality by Design guidelines gives the possibility to do continual improvements inside the original Method Operable Design Region (MODR). However, often it is necessary to do changes outside the MODR, e.g. to incorporate new technology that was not available at the time the original method was development. Here, we present a method enhancement concept which allows minor adjustments, within the same measuring principle, outside the original MODR without interaction with regulatory agencies. The feasibility of the concept is illustrated by a case study of a QC-method based on HPLC, assumed to be developed before the introduction of UHPLC, where the switch from HPLC to UHPLC is necessary as a continual improvement strategy. The concept relies on the assumption that the System Suitability Test (SST) and failure modes are relevant for other conditions outside the MODR as well when the same measuring principle is used. It follows that it should be possible to move outside the MODR as long as the SST has passed. All minor modifications of the original, approved QC-method must be re-validated according to a template given in the original submission and a statistical equivalence should be shown between the original and modified QC-methods. To summarize, revalidation is handled within the pharmaceutical quality control system according to internal change control procedures, but without interaction with regulating agencies.
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| 2. |
- Abarenkov, Kessy, et al.
(författare)
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Annotating public fungal ITS sequences from the built environment according to the MIxS-Built Environment standard – a report from a May 23-24, 2016 workshop (Gothenburg, Sweden)
- 2016
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Ingår i: MycoKeys. - : Pensoft Publishers. - 1314-4057 .- 1314-4049. ; 16, s. 1-15
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Tidskriftsartikel (refereegranskat)abstract
- Recent molecular studies have identified substantial fungal diversity in indoor environments. Fungi and fungal particles have been linked to a range of potentially unwanted effects in the built environment, including asthma, decay of building materials, and food spoilage. The study of the built mycobiome is hampered by a number of constraints, one of which is the poor state of the metadata annotation of fungal DNA sequences from the built environment in public databases. In order to enable precise interrogation of such data – for example, “retrieve all fungal sequences recovered from bathrooms” – a workshop was organized at the University of Gothenburg (May 23-24, 2016) to annotate public fungal barcode (ITS) sequences according to the MIxS-Built Environment annotation standard (http://gensc.org/mixs/). The 36 participants assembled a total of 45,488 data points from the published literature, including the addition of 8,430 instances of countries of collection from a total of 83 countries, 5,801 instances of building types, and 3,876 instances of surface-air contaminants. The results were implemented in the UNITE database for molecular identification of fungi (http://unite.ut.ee) and were shared with other online resources. Data obtained from human/animal pathogenic fungi will furthermore be verified on culture based metadata for subsequent inclusion in the ISHAM-ITS database (http://its.mycologylab.org).
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| 3. |
- Abila, R., et al.
(författare)
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Oil extraction imperils Africa’s Great Lakes
- 2016
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Ingår i: Science. - : American Association for the Advancement of Science (AAAS). - 0036-8075 .- 1095-9203. ; 354:6312, s. 561-562
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- As the world's demands for hydrocarbons increase (1), remote areas previously made inaccessible by technological limitations are now being prospected for oil and gas deposits. Virtually unnoticed by the public, such activities are ongoing in the East African Great Lakes region, threatening these ecosystems famed for their hyper-diverse biota, including the unique adaptive radiations of cichlid fishes (2). Countries in the region see exploitation of hydrocarbon reserves as a vital economic opportunity. In the Lake Albert region of Uganda, for example, the government foresees a $3.6 billion oil profit per year starting in 2018—a sum almost as high as the country's current annual budget (3). However, oil extraction in the East African Great Lakes region poses grave risks to the environment and local communities.
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| 4. |
- Adrian-Kalchhauser, Irene, et al.
(författare)
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The mitochondrial genome sequences of the round goby and the sand goby reveal patterns of recent evolution in gobiid fish
- 2017
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Ingår i: BMC Genomics. - : Springer Science and Business Media LLC. - 1471-2164. ; 18:1
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Tidskriftsartikel (refereegranskat)abstract
- Background Vertebrate mitochondrial genomes are optimized for fast replication and low cost of RNA expression. Accordingly, they are devoid of introns, are transcribed as polycistrons and contain very little intergenic sequences. Usually, vertebrate mitochondrial genomes measure between 16.5 and 17 kilobases (kb). Results During genome sequencing projects for two novel vertebrate models, the invasive round goby and the sand goby, we found that the sand goby genome is exceptionally small (16.4 kb), while the mitochondrial genome of the round goby is much larger than expected for a vertebrate. It is 19 kb in size and is thus one of the largest fish and even vertebrate mitochondrial genomes known to date. The expansion is attributable to a sequence insertion downstream of the putative transcriptional start site. This insertion carries traces of repeats from the control region, but is mostly novel. To get more information about this phenomenon, we gathered all available mitochondrial genomes of Gobiidae and of nine gobioid species, performed phylogenetic analyses, analysed gene arrangements, and compared gobiid mitochondrial genome sizes, ecological information and other species characteristics with respect to the mitochondrial phylogeny. This allowed us amongst others to identify a unique arrangement of tRNAs among Ponto-Caspian gobies. Conclusions Our results indicate that the round goby mitochondrial genome may contain novel features. Since mitochondrial genome organisation is tightly linked to energy metabolism, these features may be linked to its invasion success. Also, the unique tRNA arrangement among Ponto-Caspian gobies may be helpful in studying the evolution of this highly adaptive and invasive species group. Finally, we find that the phylogeny of gobiids can be further refined by the use of longer stretches of linked DNA sequence.
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| 5. |
- Asnicar, Davide, et al.
(författare)
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Sand Goby : An Ecologically Relevant Species for Behavioural Ecotoxicology
- 2018
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Ingår i: Fishes. - : MDPI. - 2410-3888. ; 3:1
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Tidskriftsartikel (refereegranskat)abstract
- Locomotion-based behavioural endpoints have been suggested as suitable sublethal endpoints for human and environmental hazard assessment, as well as for biomonitoring applications. Larval stages of the sand goby (Pomatoschistus minutus) possess a number of attractive qualities for experimental testing that make it a promising species in behavioural ecotoxicology. Here, we present a study aimed at developing a toolkit for using the sand goby as novel species for ecotoxicological studies and using locomotion as an alternative endpoint in toxicity testing. Exposure to three contaminants (copper (Cu), di-butyl phthalate (DBP) and perfluorooctanoic acid (PFOA) was tested in the early life stages of the sand goby and the locomotion patterns of the larvae were quantified using an automatic tracking system. In a photo-motor test, sand goby larvae displayed substantially higher activity in light than in dark cycles. Furthermore, all tested compounds exerted behavioural alterations, such as hypo- and hyperactivity. Our experimental results show that sand goby larvae produce robust and quantifiable locomotive responses, which could be used within an ecotoxicological context for assessing the behavioural toxicity of environmental pollutants, with particular relevance in the Nordic region. This study thus suggests that sand goby larvae have potential as an environmentally relevant species for behavioural ecotoxicology, and as such offer an alternative to standard model species.
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| 6. |
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| 7. |
- Blom, Eva-Lotta, 1973, et al.
(författare)
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Acoustic and visual courtship traits in two sympatric marine Gobiidae species – Pomatoschistus microps and Pomatoschistus minutus
- 2016
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Ingår i: Environmental Biology of Fishes. - : Springer Science and Business Media LLC. - 0378-1909 .- 1573-5133. ; 99, s. 999-1007
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Tidskriftsartikel (refereegranskat)abstract
- Divergence in courtship traits across species can evolve as adaptations to different environments, and also through avoidance of reproductive interference and character displacement. Differences may also be explained by phylogenetic relationships. We compared different courtship traits, including male courtship sounds, in two sympatric Pomatoschistus species. Both species are characterised by having male and female courtship, and paternal care of eggs in nests under mussel shells and rocks. In addition to presenting novel observations, we reviewed the literature on courtship traits for both species and complemented it with new observations. We found that courting males of the common goby P. microps sing louder and produce sounds of shorter duration than males of the sand goby P. minutus. Furthermore, males of P. microps swim faster towards females during courtship than males of P. minutus. The eyes of P. minutus females turn black during courtship attempts, whereas this is not the case for females of P. microps. Species-specific differences in courtship sounds and behavior may lead to different susceptibility of the two species to environmental change such as noise pollution and turbidity.
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| 8. |
- Blom, Eva-Lotta, 1973, et al.
(författare)
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Continuous but not intermittent noise has a negative impact on mating success in a marine fish with paternal care
- 2019
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- Anthropogenic underwater noise is a global pollutant of increasing concern but its impact on reproduction in fish is largely unknown. Hence, a better understanding of its consequences for this important link to fitness is crucial. Working in aquaria, we experimentally tested the impact of broadband noise exposure (added either continuously or intermittently), compared to a control, on the behaviour and reproductive success of the common goby (Pomatoschistus microps), a vocal fish with exclusive paternal care. Compared to the intermittent noise and control treatments, the continuous noise treatment increased latency to female nest inspection and spawning and decreased spawning probability. In contrast, many other female and male pre-spawning behaviours, and female ventilation rate (proxies for stress levels) did not differ among treatments. Therefore, it is likely that female spawning decisions were delayed by a reduced ability to assess male acoustic signals, rather than due to stress per se and that the silent periods in the intermittent noise treatment provided a respite where the females could assess the males. Taken together, we show that noise (of similar frequency range as anthropogenic boat noise) negatively affects reproductive success, particularly under a continuous noise exposure.
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| 9. |
- Lindsay, Willow, 1980, et al.
(författare)
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Endless forms of sexual selection
- 2019
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Ingår i: PeerJ. - : PeerJ. - 2167-8359. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- In recent years, the field of sexual selection has exploded, with advances in theoretical and empirical research complementing each other in exciting ways. This perspective piece is the product of a "stock-taking'' workshop on sexual selection and sexual conflict. Our aim is to identify and deliberate on outstanding questions and to stimulate discussion rather than provide a comprehensive overview of the entire field. These questions are organized into four thematic sections we deem essential to the field. First we focus on the evolution of mate choice and mating systems. Variation in mate quality can generate both competition and choice in the opposite sex, with implications for the evolution of mating systems. Limitations on mate choice may dictate the importance of direct vs. indirect benefits in mating decisions and consequently, mating systems, especially with regard to polyandry. Second, we focus on how sender and receiver mechanisms shape signal design. Mediation of honest signal content likely depends on integration of temporally variable social and physiological costs that are challenging to measure. We view the neuroethology of sensory and cognitive receiver biases as the main key to signal form and the 'aesthetic sense' proposed by Darwin. Since a receiver bias is sufficient to both initiate and drive ornament or armament exaggeration, without a genetically correlated or even coevolving receiver, this may be the appropriate 'null model' of sexual selection. Thirdly, we focus on the genetic architecture of sexually selected traits. Despite advances in modern molecular techniques, the number and identity of genes underlying performance, display and secondary sexual traits remains largely unknown. In-depth investigations into the genetic basis of sexual dimorphism in the context of long-term field studies will reveal constraints and trajectories of sexually selected trait evolution. Finally, we focus on sexual selection and conflict as drivers of speciation. Population divergence and speciation are often influenced by an interplay between sexual and natural selection. The extent to which sexual selection promotes or counteracts population divergence may vary depending on the genetic architecture of traits as well as the covariance between mating competition and local adaptation. Additionally, post-copulatory processes, such as selection against heterospecific sperm, may influence the importance of sexual selection in speciation. We propose that efforts to resolve these four themes can catalyze conceptual progress in the field of sexual selection, and we offer potential avenues of research to advance this progress.
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| 10. |
- Olsson, Karin H., 1979, et al.
(författare)
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Dark eyes in female sand gobies indicate readiness to spawn
- 2017
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Ingår i: Plos One. - : Public Library of Science (PLoS). - 1932-6203. ; 12:6
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Tidskriftsartikel (refereegranskat)abstract
- In animals, colorful and conspicuous ornaments enhance individual attractiveness to potential mates, but are typically tempered by natural selection for crypsis and predator protection. In species where males compete for females, this can lead to highly ornamented males competing for mating opportunities with choosy females, and vice versa. However, even where males compete for mating opportunities, females may exhibit conspicuous displays. These female displays are often poorly understood and it may be unclear whether they declare mating intent, signal intrasexual aggression or form a target for male mate preference. We examined the function of the conspicuous dark eyes that female sand gobies temporarily display during courtship by experimentally testing if males preferred to associate with females with artificially darkened eyes and if dark eyes are displayed during female aggression. By observing interactions between a male and two females freely associating in an aquarium we also investigated in which context females naturally displayed dark eyes. We found that dark eyes were more likely to be displayed by more gravid females than less gravid females and possibly ahead of spawning, but that males did not respond behaviorally to dark eyes or prefer dark-eyed females. Females behaving aggressively did not display dark eyes. We suggest that dark eyes are not a signal per se but may be an aspect of female mate choice, possibly related to vision.
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