Drug Evaluation

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.

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.

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, 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.

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).

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.

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.

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 

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

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.