PUBLICATIONS

• E-BOOK: Ocular Cell and Gene Therapy Preclinical Reference Guide

  This e-book aims to overview cell and gene therapies for ocular diseases from a preclinical drug development perspective. We provide descriptions of best practices in the use of  suitable test […]

• E-BOOK: Preclinical Toxicology Reference Guide, 2nd Edition

  This guide provides an overview of preclinical and non-clinical safety and toxicology studies necessary to be conducted for a successful IND submission and advance a drug candidate through the development […]

• E-BOOK: Transporter Reference Guide, 6th Edition

  Stay up-to-date with the FDA’s latest recommendations for drug metabolism, drug transporters and protein binding with our new Drug Metabolism and Transporters Reference Guide. The guide includes the details about […]

• E-BOOK: Potency Assay Guide, 3rd Edition

  Download the Potency Assay Guide to get expert insight on guidance and considerations. Included in the guide: Potency Assay Introduction Why it’s so important, and where to begin Roadmap of In […]

• E-BOOK: EYEdentify – Ocular Considerations

  This booklet was written by the team of ocular experts at Absorption Systems and is dedicated to special considerations in preclinical ocular studies. It is our hope that you will […]

• INFOGRAPHIC: Gene Therapy R&D Roadmap – Tools and Techniques

  This infographic explores the tools and techniques used during the AAV gene therapy development pathway, detailing the necessary steps during the process; from rAAV generation and in vitro and in vivo testing through […]

• WHITE PAPER: Bioassays: Fundamental to an integrated bioequivalence approach

  Abstract The use of generic medicines can help to alleviate drug shortages, reduce costs, and enhance patient access to treatment. Greater than 80% of drugs prescribed in the USA are […]

• WHITE PAPER: Evaluation of an Alternative System for In Vitro Metabolite Profiling

  Abstract Two of the most critical aspects in characterization studies are understanding new drug metabolism and identifying its metabolites. A metabolic profile of the new drug is established to assess […]

• WHITE PAPER: IDAS – The Future of Dissolution and Permeation Evaluation

  Abstract One of the hurdles for any solid oral drug product (tablet or capsule) is the assessment of dissolution, the rate, and extent of release of the drug substance (active […]

• WHITE PAPER: Implantable medical devices – a clinical approach to designing preclinical studies

  Abstract Implantable medical devices are being increasingly used in both established and novel clinical applications. Given their invasive nature, such devices are subject to some of the strictest regulations and […]

• WHITE PAPER: Lysosomal Trapping, Cytotoxicity, and Cellular Partitioning of Test Compounds using Hepatocytes

  Lysosomes are a motley collection of membrane-bound cellular organelles that play a variety of roles in cellular degradation, metabolism, cellular signaling, and programmed cell death. Lysosomal sequestration can be a […]

• WHITE PAPER: NAb-bed Again: Challenges in Developing Neutralizing and Anti-drug Antibody Assays for Gene Therapy

  Abstract Gene Therapy is one of the most recent and fast-growing fields of medicine, which promises to change the way we approach and treat different diseases, including many which were […]

• WHITE PAPER: Potency Assay Development for Cell and Gene Therapy Products

  Abstract: The Issue Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity and potency that are validated and performed under current Good Manufacturing Processes […]

• WHITE PAPER: The route less traveled – Utilizing pre-clinical models to address challenges with novel drug delivery systems

  Abstract Novel drug delivery systems offer impactful solutions to improve upon existing pharmaceutical products. These delivery systems often lead to enhanced bioavailability as well as improved systemic and local safety […]

• ARTICLE: Comprehensive Ocular and Systemic Pharmacokinetics of Brinzolamide in Rabbits After Intracameral, Topical, and Intravenous Administration

  Published January 2021 by the Journal of Pharmaceutical Sciences Authored by:  Vatsala Naageshwaran a, b, Veli-Pekka Ranta b, Glenwood Gum a, Siddhartha Bhoopathy a, Arto Urtti b, c, d, Eva […]

• E-BOOK: Immunogenicity Best Practices

  This booklet was written by the team of Absorption Systems’ experts dedicated to immunogenicity testing. It is our hope that you will benefit from the information, guidance, and considerations it […]

• E-BOOK: Simplifying The Path – Performance Testing for Intraoral Drug Delivery

  This booklet was written by the team of Absorption Systems’ experts dedicated to performance testing for intraoral drug delivery. It is our hope that you will benefit from the information, […]

• E-BOOK: Simplifying The Path – Performance Testing for Ophthalmic Drug Delivery

  This booklet was written by the team of ophthalmic experts at Absorption Systems and is dedicated to performance testing for ophthalmic drug delivery. It is our hope that you will […]

• E-BOOK: Simplifying The Path – Performance Testing for Topical Drug Delivery

  This booklet was written by the team of Absorption Systems’ experts dedicated to performance testing for topical drug delivery. It is our hope that you will benefit from the information, […]

• E-BOOK: BCS-Based Biowaivers

  For over 20 years, the USFDA has advocated the Biopharmaceutics Classification System (BCS) as a regulatory mechanism for drug developers and generic companies to obtain waivers of clinical bioequivalence studies, […]