Drug evaluation | Expert Collection | Author Services

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Drug Evaluation

A guide for authors submitting to the Expert Collection

Scope

Drug Evaluations will present an evaluated overview of the clinical experience with the orphan designated compound. Although discussion should encompass basic pharmacology and pharmacokinetics, the primary focus of the review should be the clinical efficacy of the compound. For launched compounds the information should be limited to approved indications and avoid off-label discussion. More details on journal-specific scope requirement can be found at the end of this page.

Audience

The audience will consist of scientists and managers in the pharmaceutical industry and other regulatory and marketing decision makers involved in healthcare provision.

Word limit

The word limit for Drug Evaluations is 3,000-5,000 words (not including tables, figures and references).

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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. For a detailed description of the journal’s peer review process, authors are referred to the journal’s website.

Every article must contain

Title

Should be concise but informative, and contain no brand names. Titles should be impartial and non-promotional.

Authors’ names and addresses

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.

Structured abstract

The abstract should be a maximum of 200 words. 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 summarise briefly their Expert opinion section.

References must not be included in the abstract.

Keywords

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.

Introduction

Incorporating basic information on disease incidence and prevalence, unmet medical need and present treatment guidelines (highlighting regional variations where appropriate).

Body of the article

– 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, Pharmacokinetics and metabolism.
– Clinical efficacy: (Phase I studies); Phase II studies; Phase III studies; Post-marketing surveillance (depending on stage of drug and data availability).
– Safety and tolerability
– Regulatory affairs: Include information on the status of the drug, i.e., if approved, where (in which countries) it is currently approved and for what indications. This should cover Europe, US and rest of the world where appropriate. 
– Conclusion: An analysis of the data presented in the review.

Expert Opinion

To distinguish reviews published in the Expert Collection 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. In developing this drug, what are the key lessons for R&D scientists in the field? Could these lessons be applied to similar R&D in associated fields?
3. What, if any, impact is this drug/therapy likely to have on current treatment strategies?
4. How likely are physicians to prescribe the drug?
5. What data is still needed?
6. Where is the drug likely to be in 5 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 (exceptions outlined in scope section below).

Drug summary box

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:

Drug summary box
If you are unable to provide this information, editorial support will be provided.

References

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.

Annotated bibliography

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).

Figures and tables

Up to five figures and five tables are permitted. For further information on tables and figures, please see our formatting guide.

Expert Opinion journal-specific scope requirements

Please note that some “Expert Opinion” journals have specific requirements for the stage which the drug has reached in the drug development pipeline. The journals will only consider submissions that describe research within this scope. Full scope details can be found on the journal’s Aims & Scope pages, but details specific to Drug Evaluations can be found below: 

Expert Opinion on Investigational Drugs

Will only consider evaluations of compounds that are in Phase II clinical trials.

Expert Opinion on Drug Metabolism & Toxicology

Drug evaluations should provide an independent perspective on the metabolism and toxicology of a specific drug, and the impact this has on the clinical efficacy. The main focus should be on: 

– Chemistry
 
– Pharmacodynamics (Effect of the body on the drug, including time course of absorption, bioavailability, distribution, metabolism, and excretion) 

– Pharmacokinetics & 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 summarising 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 (toxicokinetics). 

– Pharmacogenetics (Effect of genetic differences on response to drugs (where data is available); clinical/population pharmacokinetics)

– Effect of genetic differences on response to drugs (where data is available).

– Clinical/population pharmacokinetics 

Expert Opinion on Biological Therapy

Will only consider evaluations of drugs classed as therapeutic biological products.

Expert Opinion on Orphan Drugs

Will only consider evaluations of drugs that have orphan drug designation. Drug Evaluations in this journal should also provide detail on why the indication is considered rare (including information on epidemiology and prevalence), detail the history of orphan drug designation, include expert opinion on any R&D lessons that can be applied across other rare diseases/niche indications, and add the date and location of ODD to the drug summary box.