This issue of the journal "Pharmacokinetics and Pharmacodynamics" is being published at a pivotal moment for our publication. Assuming the responsibilities of Editor-in-Chief, I am fully aware of the extent of my responsibility for the future of a journal that has served as a platform for specialists in fundamental pharmacology for more than twenty years.

I wish to express my gratitude to Doctor of Medical Sciences, Professor, Honored Scientist of the Russian Federation Vladimir Zherdev, who for a long time acted as the permanent leader of the journal, shaping its agenda with interesting works reflecting the trends in pharmacological science.

Dear Vladimir Pavlovich, I wholeheartedly congratulate you on your 80th birthday! Please accept my deepest gratitude and profound respect for your rich life experience, high qualifications, and invaluable contribution to the work of the journal and the Pharmacokinetics Laboratory at the Zakusov Institute of Pharmacology, as well as to the development of research in this field in our country. I wish you good health, vigour, well-being, and all the very best!

Current challenges demand new and decisive strategic steps from us.

Fundamental research in such practical areas as pharmacy and biomedicine must be transformed into applied research aimed at the development of modern medicines. Such are the demands of the time and the actual request of the state, which is investing financial resources in the Programme of Fundamental Scientific Research in the Russian Federation for the long-term period (2021–2030), approved by Decree No. 3684-r of the Government of the Russian Federation of December 31, 2020. We should not forget that the vast majority of fundamental research in Russia is carried out by state-funded organisations using resources allocated for the performance of state assignments. I believe I am not mistaken in my position that the desired end result of utilising these resources is not annual reports for the regulator and the Russian Academy of Sciences, but products that, in our case, will enter pharmaceutical retail or the clinical setting.

Modern drug development is characterised by the integration of life sciences with mathematics, physics, and computer science. A global shift in the technological paradigm, accompanied by the emergence of a synergy between biotechnology, information technology, and artificial intelligence, is playing an increasingly significant role in the development of biomedicine and pharmacy. The share of biological drug products is growing, while “small molecules” are expected to maintain their position as drivers of global market growth. Much attention is paid to the development of high-tech medicinal products (gene therapy, cell therapy, and tissue engineering). The market and regulatory requirements are shaping a demand for addressing unmet medical needs, including the treatment of orphan diseases.

A significant challenge is the development of original (innovator) drugs. This process on the international stage requires increasingly substantial funding each year, spans long time intervals (up to 10–15 years or more), and demonstrates low efficiency — no more than a few hundredths of a percent of synthesised compounds ultimately succeed in passing all stages of preclinical and clinical studies and reaching the market.

The effective alignment of research results from publicly funded organisations with the realities and needs of the pharmaceutical market remains a problem.

With regard to our journal, we must also take into account the increasing requirements for publications, global competition for authors, and the need to be included in international databases, including Scopus and PubMed Central.

Historically, our journal, starting in 2004 as "Clinical Pharmacokinetics" and since 2012 in its current format, has focused on publishing the results of studies investigating pharmacokinetic processes (absorption, distribution, metabolism, and excretion of drugs) in relation to pharmacological effects (pharmacodynamics).

In addition to these studies, the process of modern drug development encompasses an extremely wide range of tasks and tools and is aimed at establishing the basic triad applicable to all medicinal products under all international and Russian legislative acts: quality, efficacy, and safety.

Drug development begins with the stage of designing its structure. The toolkit of medicinal chemists includes, among other things, in silico drug modelling using high-performance computing on central processing units and graphics processing units. Molecular docking, molecular dynamics, and pharmacophore modelling are complemented by in silico analysis of potential pharmacokinetics and toxicity (ADMET analysis). Artificial intelligence (AI) technologies are being increasingly introduced into drug development. Between 2015 and 2023, the number of molecules designed using AI that entered clinical trials globally increased from 1 to 67 (IFPMA, "Facts & Figures").

In vitro studies, acting as a key link bridging medicinal chemistry and subsequent in vivo investigations, allow for structural and functional analysis of new compounds, identifying structure-activity relationships, adjusting chemical synthesis, evaluating ligand-receptor interactions, and testing metabolic stability — all of which are critically important for further molecule optimisation.

Research in the field of drug toxicology, including genetic and reproductive toxicology, is aimed at building a body of knowledge regarding drug safety.

It should also be taken into account that drug development cannot be carried out in isolation from understanding the drug as a future commercial product, which must be characterised by legally established parameters as well as adequate consumer properties throughout its shelf life. In this sense, pharmaceutical development issues come to the fore: the choice of dosage form, development of the composition and manufacturing technology of the drug product, including the use of mathematical design and modelling methods, ensuring the bioavailability of drugs with low permeability and solubility, standardisation of the pharmaceutical substance and the drug product using a wide range of analytical methods, and the use of modern technologies and digital innovations to improve production efficiency and ensure product quality. The results of scientific research in the course of pharmaceutical development constitute an integral part of the common technical document prepared for the purpose of drug registration.

The application of these approaches in Russia is based on the modern regulatory framework — the legal acts of the Eurasian Economic Union, which have significantly changed the requirements for drug circulation. Since January 1, 2021, the registration of medicinal products for medical use has been carried out in accordance with the Rules approved by Decision No. 78 of the Council of the Eurasian Economic Commission of November 3, 2016, which established the submission of the registration dossier in the modern common technical document format. The decisions of the EEC Council have approved the current Union rules defining the requirements for the entire drug lifecycle — the so-called good practices: laboratory (GLP), clinical (GCP), manufacturing (GMP), distribution (GDP), and pharmacovigilance (GVP).

At the same time, Eurasian regulation also provides new opportunities regarding access to medicines. In accordance with the aforementioned Registration Rules (Section VII "Establishment of Post-Registration Measures"), market entry of medicinal products may be carried out under one of the possible regimes: registration of a medicinal product in exceptional cases (when it is impossible to conduct studies in the regular format), conditional registration of a medicinal product (to address unmet medical needs with the obligation to complete the necessary studies).

In this regard, the strategic mission of the journal is to become a platform uniting all stages of modern drug development, taking into account current regulatory requirements and promising scientific achievements. We need to create an environment where medicinal chemists, biochemists, pharmacologists, geneticists, bioinformaticians, toxicologists, pharmaceutical technologists, analytical chemists, and clinicians can speak a common language and see the end result of their work in the context of a common goal — the creation of a high-quality, effective, and safe medicinal product.

A logical consequence of this mission is the expansion of the journal's scope. Starting this year, we are beginning to actively accept and publish articles in three new specialties for which academic degrees are awarded, thus organically complementing the existing specialty 3.3.6. Pharmacology, Clinical Pharmacology:

The inclusion of these areas is not a mechanical expansion of rubrics. It is the creation of an integrated "pipeline" of publications: from in silico drug modelling through in vitro, in vivo, and ex vivo studies of efficacy and safety in animals, the development of the composition and technology of the drug product, standardisation of the medicinal product (pharmaceutical substance and drug product), and further — to technology transfer to an industrial partner's manufacturing site, clinical trials, as well as monitoring of the efficacy and safety of marketed medicinal products.

We hope that this approach will attract to the journal a wide range of researchers working on the development of original, generic, and biosimilar drug products.

Alignment with the new specialties inevitably raises the question of changing the journal's name. The current title, "Pharmacokinetics and Pharmacodynamics", while being our brand and historical legacy, may create a barrier in the eyes of chemists, technologists, and analytical scientists. In this regard, to achieve the ambitious goal of becoming a leader among domestic journals in all aspects of drug development, we need rebranding.

We are approaching this process as thoughtfully as possible. At the first stage, a compromise option is possible: retaining the main title while adding a subtitle that reveals the new topics. This will preserve indexing continuity and smoothly prepare readers for the changes.

A strategy is impossible without changes in the team. Leading experts — doctors of sciences in each of the aforementioned specialties for which academic degrees are awarded — have been appointed to the editorial board. This will ensure competent peer review of manuscripts at the submission stage. We also plan to expand the editorial board by inviting distinguished international scientists.

Furthermore, we are revising our editorial policy regarding conflicts of interest and commercial names. We consider it advisable to use international nonproprietary, chemical, or grouping names of medicinal products in the titles and throughout the text of articles. The use of brand names of medicinal products is possible (for example, in the "Materials and Methods" section or in the case of bioequivalence studies) with a declaration of funding sources. We are implementing a policy of independent peer review of the work of editorial board members to eliminate conflicts of interest and increase trust in the published materials.

Dear colleagues, we stand on the threshold of great change. Transforming the journal "Pharmacokinetics and Pharmacodynamics" into a leading interdisciplinary platform covering the full drug development cycle is not an administrative task, but a historic opportunity for all of us. An opportunity to consolidate the Russian scientific community, to create an authoritative communication channel between fundamental science and practical medicine, and finally, to take a worthy place on the international stage. I invite you to cooperate, discuss, and actively participate in the life of our common journal.

Editor-in-Chief of the journal "Pharmacokinetics and Pharmacodynamics"Dr. Sci. (Pharm.), Professor V.L. Dorofeev