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Frequently asked questions

How do I balance risk versus cost in my development plan?

At the early stages of development, one must determine the essential experiments to perform to de-risk any clinical studies and meet the regulatory requirements. Equally important is the ability to determine those experiments that can be delayed until the next value inflection so as to manage the spend profile. At Seda we have vast experience in making these judgements and can work with Clients to establish a bespoke development plan that addresses the needs of the molecule and the strategic drivers of the business. We never try to force fit your molecule in to a branded, template development approach. This will ensure that spend is managed without unnecessary delays to the project timeline.

How do I gain adequate exposure in pre-clinical studies?

At Seda we have extensive experience in selecting formulation compositions to optimise exposure in animal studies, particularly those in which large doses are given. Formulations and dosing vehicles are selected based on our knowledge of dosing precedents across a range of preclinical species and the ability of the vehicles to deliver compounds in a solubilised form for oral and parenteral administration. We also have strong expertise in development of long acting formulations for dosing by subcutaneous, intramuscular and intratumoral administration.

How do I accelerate my candidate to First in Human studies?

Seda has established a framework for the rapid, successful and cost-effective development of products for clinical studies in healthy volunteers and patients. Bespoke development strategies for first time in human studies are focused on an understanding of the clinical programme combined with a developability assessment based on compound physicochemical, physicomechanical, drug absorption and pharmacokinetic properties. This allows us to quickly select the most appropriate dosage form and delivery systems for your compound from a range of proven technologies whilst developing relevant analytical methodologies for testing of product quality.

How do I optimise exposure?

Seda has access to an extensive library of enabling technologies for ensuring that the optimal PK profile and bioavailability is achieved for every compound. This covers technologies for the oral delivery of compounds with low aqueous solubility including lipidic delivery systems, liquid and semi-solid filled capsules and amorphous solid dispersions. We also have the ability to rapidly assess the suitability of particle size reduction as a means of enhancing the rate and extent of drug absorption. For compounds requiring parenteral administration, we have significant experience in the development of long-acting injections including polymeric microparticles, in-situ forming systems and oily depots.

How do I predict a Human Dose?

Our in-house drug metabolism and pharmacokinetics (DMPK) experts can guide you in the prediction of human systemic pharmacokinetics parameters. This is coupled with knowledge of the concentration and duration of coverage needed at the target tissue. A crucial additional step is the application of our proprietary in silico absorption modelling software, Nora Max, which is used to predict the fraction of the administered dose that would be absorbed, based on the compound’s physicochemical properties and formulation attributes. Via this approach, Seda can guide you in the selection of an appropriate human dose / schedule, optimising time and costs involved in formulation development for human clinical studies.

What technologies are available for drug targeting and intracellular delivery?

The changing nature of (bio)pharmaceutical pipelines has seen an increasing interest in the development of complex medicines, in particular those administered by injection. This includes a growing appetite for the development of nanomedicines and colloidal systems, including those aimed at promoting the accumulation of molecules in specific target tissues and cells such as lipid, polymeric and inorganic nanoparticles. Seda has a strong track record of supporting research organisations, biotech businesses and drug delivery companies to navigate the journey for these most complex of pharmaceutical systems into the clinic, providing deep technical insights and an understanding of regulatory requirements.

What pharmacokinetic profile should we aim for?

Rather than focussing purely on dose strength, we encourage Clients to consider the desired PK profile for optimum formulation performance. As experts in pharmacokinetic-pharmacodynamic-outcome (PK-PD) and PBPK modelling, we can assist Clients in interrogating preclinical data and translating it to a target human PK profile and thus, optimal release profile for the drug product.

How do we bridge between formulations?

When formulation or manufacturing process changes are made during development, it is important to understand whether there will be any impact on clinical performance of the drug product. Clinically relevant differences in PK profile part way through a development programme may invalidate prior safety and efficacy data or may necessitate a dose adjustment. The stage of development defines how stringently the standards are applied. Supporting data can range from comparative dissolution testing and in silico modelling, to clinical relative bioavailability studies or formal bioequivalence studies. Seda will guide you through rational design of your drug product bridging strategy, allowing your programme to progress at optimal speed and cost.

How do we meet the requirements for paediatric development?

Changes in the regulations now require the pharmaceutical industry to design and develop age appropriate formulations and perform clinical trials involving paediatrics, in addition to the development and approval of the drug product for adults. Seda has in-house expertise and a network of external thought leaders in the provision of formulation development, in silico PK prediction, taste assessment, and regulatory authoring to help you design and deliver your paediatric development program.

How do we develop an appropriate Regulatory Control Strategy?

One of the fundamental tenets of Quality by Design is to ‘start with the end in mind’. The most effective way to approach this is to think about a final, holistic Control Strategy that will form the basis of your quality assurance at the point of Product Authorisation and to focus your development efforts on this goal. This will structure your assessment and management of risk, your product design goals (through a Quality Target Product Profile) and your analytical method development.
This approach can be applied, as appropriate, at any stage of development and will maximise the value of your development asset.

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Leadership Team

Expertise:

  • Oral Drug Delivery
  • Complex Medicines
  • Paediatric Product Development
  • CMC Regulatory

Paul W Stott

BPharm (Hons) PhD

Director & CEO

Paul W Stott

BPharm (Hons) PhD

Director & CEO

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Paul is an established pharma executive with extensive global experience. Prior to joining SEDA he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.

AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul’s stewardship registered 10 global products.

At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.

He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.

He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.

Ask me a question

    Expect a reply typically within 48 hours.

    Expertise:

    • Oral Drug Delivery
    • Complex Medicines
    • Paediatric Product Development
    • CMC Regulatory
    • Analytical Sciences

    Marcel de Matas

    BSc (Hons) PhD FRSC CChem

    Director & Co-Founder

    Marcel de Matas

    BSc (Hons) PhD FRSC CChem

    Director & Co-Founder

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    Marcel has a track record in a range of management and senior scientific positions in industry and academia. Most recently he was a Principal Scientist in Product Design and Innovation at AstraZeneca, where he was responsible for introducing the latest science, new technologies (advanced drug delivery and manufacturing) and product design thinking into the Product Development group.

    Marcel has led technical activities, provided project leadership and has managed product development teams responsible for the delivery of drug projects from initial concept design through late stage development, regulatory submission and launch (including advanced drug delivery systems). He has led teams at the drug discovery-development interface, assessing the level of chemistry manufacturing and controls (CMC) technical risk and defining product design strategies in early development. Project experience has covered projects across a range of disease and therapy areas with substantial experience in the oncology field.

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      Expect a reply typically within 48 hours.

      Expertise:

      • DMPK Consultancy and Dose Selection
      • Pharmacokinetic Modelling
      • Complex Medicines
      • CMC Regulatory
      • Clinical Pharmacology
      • Analytical Sciences

      Paul A Dickinson

      BPharm (Hons) PhD

      Director & Co-Founder

      Paul A Dickinson

      BPharm (Hons) PhD

      Director & Co-Founder

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      Paul has held several senior science leadership roles in Academia and Large Pharma.  These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.

       

      Immediately prior to founding Seda Pharmaceutical Development Services Paul was Senior Clinical Pharmacology Scientist at AstraZeneca and led the clinical pharmacology program to NDA/MAA for AZD9291/osimertinib, which had been awarded ‘breakthrough therapy’ status by the FDA.  Formerly Paul was a Principal Scientist within Pharmaceutical Development (AZ) leading both the global biopharmaceutics network and the Medicines Evaluation science community (USA, SE, UK).

       

      Paul has been at the forefront of recent advances in the understanding of in vitro performance criteria that assure product performance in the patient including clinically relevant dissolution specifications (CRDS).  Paul has co-authored papers with FDA staff focussed on efforts to combine biopharmaceutics with ICH Q8 (BioRAM) and is past Chair of the AAPS ‘QbD and product performance’ focus group.

       

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        Our Subject Matter Experts

        Expertise:

        • Oral Drug Delivery
        • DMPK Consultancy and Dose Selection
        • Pharmacokinetic Modelling
        • Clinical Pharmacology

        Linette Ruston

        BSc (Hons) PhD

        Senior Principal Scientist: ADME

        Linette Ruston

        BSc (Hons) PhD

        Senior Principal Scientist: ADME

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        Linette is a Senior Principal Scientist at Seda with a BSc (Hons) and PhD in Chemistry from Universities of Glasgow and Edinburgh, respectively.  She is an experienced Biopharmaceutics and DMPK scientist having spent 17+ years with AstraZeneca where she held roles in Discovery and Early Pharmaceutical Development, providing expert physicochemical, ADME and Biopharmaceutics input into compound design and selection, and applied knowledge of in vitro, in silico and in vivo models to enable material choice and project progression from discovery to early clinical development.  Her current focus is on translation of DMPK/PD and biopharmaceutics understanding into meaningful product and clinical study design within Seda.

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          Expect a reply typically within 48 hours.

          Expertise:

          • Pharmacokinetic Modelling

          Jake Dickinson

          BSc (Hons)

          Senior Modeller

          Jake Dickinson

          BSc (Hons)

          Senior Modeller

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          A physics graduate, with over 3 years’ experience in the pharmaceutical industry. Jake has applied analytical, mathematical, and problem-solving skills to the assessment of the likelihood of drug candidate success and to identify the likely risks involved in the formulation of a drug. Areas of expertise include PK / PK-PD-TGI modelling in preclinical species and translation to man to aid in dose prediction. Jake has developed models and applications including Nora Max, an in silico absorption model, that aids decision making in late preclinical and early clinical drug development phases of drug development and enables the identification of the formulation technologies required for FiH.

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            Expect a reply typically within 48 hours.

            Expertise:

            • Oral Drug Delivery
            • Paediatric Product Development

            Shanoo Buhdheo

            BSc (Hons)

            Senior Principal Scientist

            Shanoo Buhdheo

            BSc (Hons)

            Senior Principal Scientist

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            Shanoo is an experienced pharmaceutical development scientist with many years’ experience in large pharma and the biotech sector. She has a particular interest in biopharmaceutics, development of clinically relevant in vitro tests and the development of products for paediatrics.

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              Expect a reply typically within 48 hours.

              Expertise:

              • Complex Medicines
              • Pharmacokinetic Modelling
              • Clinical Pharmacology

              Claire Patterson

              MPharm (Hons) PhD

              Senior Principal Scientist

              Claire Patterson

              MPharm (Hons) PhD

              Senior Principal Scientist

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              Claire Patterson is Senior Principal Scientist at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London respectively. Claire is an experienced Biopharmaceutics scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, linking in vitro to in vivo product performance. Current focus areas include subcutaneous and complex parenteral biopharmaceutics (including nanomedicines) and other non-oral routes of administration.

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                Expect a reply typically within 48 hours.

                Expertise:

                • Oral Drug Delivery
                • CMC Regulatory

                Nicola Parisi

                MSc PhD

                Principal Scientist

                Nicola Parisi

                MSc PhD

                Principal Scientist

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                Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years’ experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.

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                  Expect a reply typically within 48 hours.

                  Expertise:

                  • Oral Drug Delivery

                  Wang Wang Lee

                  MPharm (Hons) PhD GPhC

                  Principal Scientist

                  Wang Wang Lee

                  MPharm (Hons) PhD GPhC

                  Principal Scientist

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                  Wang Wang Lee is a GPhC registered pharmacist with a PhD in Pharmaceutical Sciences and MBA from the University of Strathclyde. She has deep industry and academic experience particularly in the areas of biopharmaceutics and product development. Her expertise in early and late-stage development, risk assessing and mitigating the development challenges has helped clients transition compounds into the clinic from discovery.

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                    Expect a reply typically within 48 hours.

                    Expertise:

                    • Complex Medicines
                    • Oral Drug Delivery

                    Paul Gellert

                    BA DPhil

                    Consultant - Complex Medicines

                    Paul Gellert

                    BA DPhil

                    Consultant - Complex Medicines

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                    Paul has 33+ years’ experience in Drug Discovery and Development at AstraZeneca, specialising in novel formulation, drug delivery and product design. He has led many projects and teams in identifying, evaluating and designing novel viable drug delivery-based products and new drug delivery technologies across a broad range of routes of administration and drug modalities including many complex medicines.

                    From 2017 to 2021, in additional to his role as Senior Principal Scientist in Drug Delivery, Paul was the Science & Innovation Director for Drug Delivery and Product Design, accountable for driving and championing science and innovation in drug delivery and product design to create new implementable business opportunities. Paul started and led AstraZeneca’s Global Novel Drug Delivery Network for many years and is widely recognised outside AstraZeneca as an expert on drug delivery technologies and the external drug delivery environment, including patent and intellectual property aspects.

                    Paul has collaborated extensively with academic groups and drug delivery companies and is the co-author and co-inventor of a number of publications and patent applications. He has been a member of a range of external groups including Editorial advisory board member for the Nanomedicine journal, Scientific Advisory Board member and Programme Chair for the Controlled Release Society Conference, Scientific Consultant to the Wellcome Trust and EPSRC programme External Advisory Board member.

                     

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                      Expertise:

                      • Chemical Development
                      • CMC Regulatory

                      Bill Moss

                      BSc (Hons) PhD

                      Consultant - Chem. Dev.

                      Bill Moss

                      BSc (Hons) PhD

                      Consultant - Chem. Dev.

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                      Dr Bill Moss has over 25 years’ experience as a scientist and leader working in the following areas:

                      • Chemical Development and manufacture of clinical and commercial drug substance
                      • Expertise in the Discovery interface, Preclinical and Phase1/Phase II development, supporting the progression of new candidate drugs from discovery into development
                      • Drug substance project strategy development and integration with drug product, safety and clinical planning
                      • Extensive experience of outsourcing drug substance development and manufacture
                      • Authoring and reviewing regulatory submissions from Phase I to marketing submissions

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                        Expect a reply typically within 48 hours.

                        Expertise:

                        • Analytical Sciences
                        • CMC Regulatory

                        Peter Doyle

                        BSc (Hons) MSc PhD

                        Consultant - Analytical Sci.

                        Peter Doyle

                        BSc (Hons) MSc PhD

                        Consultant - Analytical Sci.

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                        Peter has worked in the pharmaceutical and healthcare sector for over 25 years with leadership and scientific positions at J&J, AstraZeneca and Glaxo. He has extensive experience in the management of outsourced projects with a focus on analytical development activities. Peter has authored many regulatory submissions from FiH to NDA / MAA and has an expert understanding of the regulatory requirements at each stage of development. He has been a consultant to the biotech sector since 2017.

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                          Expect a reply typically within 48 hours.

                          Expertise:

                          • Oral Drug Delivery

                          Talbir Austin

                          BSc (Hons) PhD CChem MRSC

                          Consultant - Material Sciences

                          Talbir Austin

                          BSc (Hons) PhD CChem MRSC

                          Consultant - Material Sciences

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                          Dr Talbir (Tal) Austin is a consultant providing expertise in solid state, material design and characterisation, and development with particular focus on the early development phase.

                          Dr Austin is a structural organic chemist who has worked within the pharmaceutical industry for nearly three decades. Her previous positions involved complex problem solving and troubleshooting of projects – overseeing material design, selection and development, from the Preclinical phase through to Early Development at AstraZeneca. She also led the design and implementation of AstraZeneca’s material selection strategy at the discovery and development interface. Dr Austin has extensive experience in optimising material properties for different therapy areas (Respiratory, Inflammation, CNS, CV, GI and Oncology) and modes of administration; oral, inhalation, parenteral, topical.

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                            Expect a reply typically within 48 hours.

                            Expertise:

                            • CMC Regulatory

                            Roy Jamieson

                            BPharm (Hons)

                            Consultant - Regulatory CMC

                            Roy Jamieson

                            BPharm (Hons)

                            Consultant - Regulatory CMC

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                            Roy is an experienced Pharma Industry & Regulatory CMC professional having spent time as a quality assessor at MHRA and with over 25 years in large pharma organisations leading numerous small molecule projects from FTiH through Marketing Authorisation and launch. As an Independent Consultant he has worked with many small companies as well as collaborating with consultancy firms and is currently supporting the South African Agency (SAHPRA) as a Quality/CMC reviewer supporting their generic backlog programme.

                            Roy has successfully led 4 major global submissions through Phase 3 to marketing authorisation approval. His key area of regulatory scientific expertise and interest centres on biopharmaceutics aspects of solid oral dosage forms of small molecules and the bridge between quality performance and the pharmacokinetic profile linked to safety and efficacy.

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                              Expect a reply typically within 48 hours.

                              Expertise:

                              • Pharmacokinetic Modelling

                              Parmesh Gajjar

                              BA (Hons) MMath PhD

                              Principal Scientist

                              Parmesh Gajjar

                              BA (Hons) MMath PhD

                              Principal Scientist

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                              Parmesh has a strong mathematical background with a BA (Hons) & MMath from the University of Cambridge and a PhD in Applied Mathematics from the University of Manchester. He has 5 years of pharmaceutical experience working on the physical characterisation of inhalation medicines, working alongside large Pharma and Contract Drug Manufacturing Organisations (CDMOs). At SEDA, he will be applying his problem-solving ability to pharmacokinetic and pharmacodynamic modelling.

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                                Expect a reply typically within 48 hours.

                                Expertise:

                                • Complex Medicines

                                Fanny Joubert

                                BSc (Hons) PhD

                                Senior Scientist

                                Fanny Joubert

                                BSc (Hons) PhD

                                Senior Scientist

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                                Fanny has a strong educational training with a bachelor’s degree in chemistry followed by an engineer diploma in Materials Science and finally a PhD in Polymer Chemistry. Following her studies, she has worked as a Research Associate for 6+ years in both Academia and large Pharma focussing on polymers for healthcare and precision nanomedicine applications. She joined Seda as Senior Scientist to facilitate the development of complex parenterals using her knowledge of Nanotechnology.

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                                  Expect a reply typically within 48 hours.

                                  Team page >

                                  Our latest news

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                                  Movers and Shakers in BioBusiness 2021
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                                  Appointment of Paul Gellert
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                                  Publication of Influential Workshop Output on Physiologically Based Biopharmaceutics Modelling (PBBM)
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                                  Our latest Research Papers & Books

                                  July 2022

                                  Population PK modelling as an alternative route to bioequivalence

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                                  May 2022

                                  Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

                                  Read

                                  Jan 2022

                                  Biopharmaceutics: From Fundamentals to Industrial Practice

                                  Read

                                  September 2021

                                  First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies

                                  Read

                                  Dec 2020

                                  Predicting bioavailability of monoclonal antibodies after subcutaneous administration: Open innovation challenge

                                  Read

                                  November 2020

                                  Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

                                  Read

                                  Nov 2020

                                  IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 4: Prediction accuracy and software comparisons with improved data and modelling strategies

                                  Read

                                  Jul 2020

                                  Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

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                                  Dec 2018

                                  Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin

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                                  April 2022

                                  Development of a methodology to enable non-linear in vitro-in vivo correlation for complex long-acting injections

                                  Read