NEW RELEASEIssue 41 — Immunomodulation Assessments for Clinical Trials

Immunomodulatory drug development is trending toward increasingly complex modalities as science advances and more effective and safe immunotherapies are needed.

Issue 42 — Managing the Complexities of Glucagon -like Peptide-1 Receptor Agonist Drug Development

Issue 41 — Immunomodulation Assessments for Clinical Trials: Sophisticated Bioanalytical Approaches to Support Complex Modalities

Issue 40 — Analytical Testing: Accurate and Complete Characterization Of Your API to Maximize Bioavailability

Issue 39 — Considerations for Nonclinical Dermal Studies: Advancing to Phase I

Issue 38 — Optimal Preclinical Formulation and Drug Product Manufacture

Issue 37 — Quantitative PCR and Droplet Digital: Leading-Edge Analysis for Your Gene Therapy Programs

Issue 36 — Nonclinical Studies in Cell and Gene Therapy

Issue 35 ― Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs

Issue 34 — Toxicokinetics, Pharmacokinetics, and Pharmacodynamics

Issue 33 — CNS Drug Development: Integrated Solutions Lessen Complexity

Issue 32 — A Changing Paradigm for Non-Rodent Species in Nonclinical Safety Studies

Issue 31 — The Advantages of Conducting Early Phase Clinical Research in Canada

Issue 30 — The Evolution and Advancement of LCMS in Drug Development

Issue 29 — Data Journey: Building Your Early Phase Clinical Trial Data, From Protocol to Regulatory Submission

Issue 28 — Applications of Liquid-Filled Hard-Shell Capsules in Drug Development

Issue 27 — The Complexities of Early Phase Ophthalmic Drug Development

Issue 26 — CDISC Standards: Simplifying and Expediting Data Management and Analysis

Issue 25 ― Flexibility in Phase I Study Timing

Issue 24 — Shortening Drug Development with Asian Ethnobridging

Issue 23 ― Robust Sample Management for Reliable Study Results

Issue 22 ― Nanomilling for Better Solubility and Improved Bioavailability

Issue 21 ― Terminal Sterilization for Pharmaceutical Products

Issue 20 — Validation of Immunogenicity Assays

Issue 19 ― Psychedelics and Entactogens

Issue 18 — Planning Your First-in-Human Trial

Issue 17 ― Maximizing Drug Formulation for First-in-Human Trials

Issue 16 ― Microsampling: Applications, Benefits, and Considerations

Issue 15 — Early Phase Drug Development Continuity in the Era of COVID-19

Issue 14 — CNS Active Drugs: Complex Considerations

Issue 13 ― Safety Pharmacology Guidelines and Practices: A Review

Issue 12 — Antisense Oligonucleotides

Issue 11 — Navigating the IND Submission Process

Issue 10 — Tackling Early Phase Development Challenges with Effective First-in-Human Studies

Issue 9 — Cardiac Safety Assessment in Clinical Trials

Issue 8 — Bioanalytical Challenges Encountered When Developing ADA Assays

Issue 7 — Understanding the Intrinsic and Extrinsic Factors that Alter Drug Exposure and Toxicity

Issue 6 — Hybrid Medicines and 505(b)(2) NDA Approval Pathways

Issue 5 — The Global Challenge of Metabolic Disorders

Issue 4 — Key Considerations for Biosimilar Clinical Pharmacology Studies

Issue 3 — Human Abuse Potential Studies

Issue 2 — Revolutionizing Traditional Medicine with Cannabis-based Medicinal Products

Issue 1 — Studying the Effects of Drugs on Driving

First-in-Human Solution for Small and Large Molecules

Altasciences' Nonclinical Safety Testing Guide

Benefits of Liquid-Filled Capsules for Pharmaceutical Development

Key Biomarkers of Immunomodulation: Complement Factors and Cytokines

One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs