Expert Opinion on Drug Metabolism & Toxicology – Pharmacokinetic Evaluation
A guide for authors submitting to the Expert Collection
Scope
Drug Evaluations focus on providing an independent perspective on the metabolism and toxicology of a specific drug, and the impact this has on the clinical efficacy.
Word limit
The word limit for Drug Evaluations is 3,000 words (not including tables, figures and references).
Peer review
All articles are subject to rigorous peer-review by 2-3 independent reviewers. As the Drug Evaluations include in-depth analysis of a single compound, the manuscript will also be sent to the company responsible for marketing or developing the drug to check the accuracy of the data. This is for a technical check only and the final editorial decision is based entirely on the recommendation of the independent peer review. Comments remain confidential and are shared only with the corresponding author or submitting party.
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Every article must contain
Titles should be concise but informative, and contain no brand names. They should also be impartial and non-promotional.
Including address, academic qualifications and job titles of all authors, as well as telephone number, fax number and email address of the author for correspondence on a separate cover sheet as the peer reviewers will be blinded to the authors’ identity.
Please note that only the address of the first author of the article will appear on Medline/PubMed, not necessarily the corresponding author.
Please note that only the address of the first author of the article will appear on Medline/PubMed, not necessarily the corresponding author.
The aim of the abstract is to draw in the interested reader and provide an accurate reflection of the content of the paper. We therefore request the following structure is followed for full-length review articles:
Introduction: Authors are required to describe the significance of the topic under discussion.
Areas covered: Authors are required to describe the research discussed and the literature search undertaken.
Expert Opinion: Authors are required to summarize briefly their Expert Opinion section.
References must not be included in the abstract.
Introduction: Authors are required to describe the significance of the topic under discussion.
Areas covered: Authors are required to describe the research discussed and the literature search undertaken.
Expert Opinion: Authors are required to summarize briefly their Expert Opinion section.
References must not be included in the abstract.
A brief list of keywords, in alphabetical order, is required to assist indexers in cross-referencing. The keywords will encompass the therapeutic area, mechanism(s) of action, key compounds etc.
Incorporating basic information on disease incidence and prevalence, unmet medical need and present treatment guidelines (highlighting regional variations where appropriate).
Overview of the market: What are the unmet needs of currently available therapies? Which competitor compounds/classes of compounds are in the clinic/late development?
Introduction to the compound
Chemistry
Pharmacodynamics: Effect of the drug on the body, including receptor binding, post-receptor effects, and chemical interactions.
Pharmacokinetics and metabolism: Effect of the body on the drug, including time course of absorption, bioavailability, distribution, metabolism, and excretion. To provide the reader with a visual summary of the pharmacokinetics of the drug, each paper should include a table summarizing published pharmacokinetic parameters, e.g. AUC, Cmax, Cmin, Ctrough, Tmax, oral clearance CL/F, (Table 1. Summary of pharmacokinetic parameters of [drug].) ADME properties as they relate to toxicity (toxicokinetic).
Pharmacogenetics: Effect of genetic differences on response to drugs (where data is available). Clinical/population pharmacokinetics.
Clinical efficacy: Summary of clinical efficacy data from Phase I-III studies and post-marketing surveillance.
Safety, tolerability, toxicity, and potential off-target effects related to safety liabilities: Indicate changes in biomarkers of harm as appropriate.
Drug-drug interactions
Dosing routes
Regulatory affairs: Indicate drug approvals from a global perspective.
Conclusion: An analysis of the data presented in the review.
Introduction to the compound
Chemistry
Pharmacodynamics: Effect of the drug on the body, including receptor binding, post-receptor effects, and chemical interactions.
Pharmacokinetics and metabolism: Effect of the body on the drug, including time course of absorption, bioavailability, distribution, metabolism, and excretion. To provide the reader with a visual summary of the pharmacokinetics of the drug, each paper should include a table summarizing published pharmacokinetic parameters, e.g. AUC, Cmax, Cmin, Ctrough, Tmax, oral clearance CL/F, (Table 1. Summary of pharmacokinetic parameters of [drug].) ADME properties as they relate to toxicity (toxicokinetic).
Pharmacogenetics: Effect of genetic differences on response to drugs (where data is available). Clinical/population pharmacokinetics.
Clinical efficacy: Summary of clinical efficacy data from Phase I-III studies and post-marketing surveillance.
Safety, tolerability, toxicity, and potential off-target effects related to safety liabilities: Indicate changes in biomarkers of harm as appropriate.
Drug-drug interactions
Dosing routes
Regulatory affairs: Indicate drug approvals from a global perspective.
Conclusion: An analysis of the data presented in the review.
To distinguish reviews published in the Expert Opinion journals, authors must provide an additional section entitled Expert Opinion. This section affords authors the opportunity to go beyond the conclusion and provide their interpretation of the data presented in the article. Authors should answer the following:
1. What, if any, improvement does the drug hold over other therapies?
2. What, if any, impact is this drug likely to have on current treatment strategies?
3. How likely are physicians to prescribe the drug?
4. What data is still needed?
5. Where is the drug likely to be in five years’ time?
Please note that ‘opinions’ are encouraged in the Expert Opinion section, and as such, referees are asked to keep this in mind when peer reviewing the manuscript. However, authors are requested to focus their discussion on approved uses of the drug.
1. What, if any, improvement does the drug hold over other therapies?
2. What, if any, impact is this drug likely to have on current treatment strategies?
3. How likely are physicians to prescribe the drug?
4. What data is still needed?
5. Where is the drug likely to be in five years’ time?
Please note that ‘opinions’ are encouraged in the Expert Opinion section, and as such, referees are asked to keep this in mind when peer reviewing the manuscript. However, authors are requested to focus their discussion on approved uses of the drug.
To provide the reader with a visual summary of the paper, each paper should include a drug summary box including basic data on the drug as follows:
If you are unable to provide this information, editorial support will be provided.
If you are unable to provide this information, editorial support will be provided.
A maximum of 100 references is suggested. Ensure that all key work relevant to the topic under discussion is cited in the text and listed in the bibliography. Reference to unpublished data should be kept to a minimum and authors must obtain a signed letter of permission from cited persons to use unpublished results or personal communications in the manuscript.
Important references should be highlighted with a one/two star system and brief annotations should be given (see the journal’s Instructions for Authors page for examples and for a more detailed description of our referencing style).
Up to five figures and five tables are permitted. For further information on tables and figures, please see our formatting guide.