Understanding a new drug’s absorption, distribution, metabolism, and excretion (ADME) is critical to ensure its safety for human use. That understanding is achieved through the collection and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data, which together account for approximately 25% of the contents of a drug package insert or label.

The characterization of PK/PD effects starts with nonclinical toxicokinetic (TK) studies in animals. The purpose of TK studies is to define the chemical properties of the drug, including pharmacology and toxicology, and to assist in the development of downstream clinical protocols. The necessary nonclinical studies are conducted before submission of Investigational New Drug (IND) applications to the FDA or other global regulatory agencies, and deliver critical data used to set the parameters for future clinical trials.

In Issue 34 of The Altascientist, we discuss how the understanding of a novel drug’s PK and PD properties begins with nonclinical studies and evolves through early-phase clinical trials, including: 

• IND requirements and translation to clinical PK/PD;
• Translating nonclinical knowledge of PK/PD analyses to clinical study;
• How PK/PD scientists add value to drug development processes; and
• A scenario case study from Altasciences.

Timely completion of necessary studies is a critical element of drug development, bringing important treatments to patients in a safe and cost-efficient way. A consideration with a measurable impact on early-phase clinical studies is the location where trials are performed; this is especially true for first-in-human (FIH) trials.

Conducting early-phase clinical research on novel compounds in Canada can provide significant advantages versus other locations.

In Issue 31 of The Altascientist, we take a deep dive into these advantages, covering:

• Canadian CTA trials–time and cost savings
• Regulatory review process predictability
• Business efficiency cost savings
• Clinical trial participants

Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.

In this journal, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

In Issue 29 of The Altascientist we explore: 

• Protocol development
• Data management
• Statistical support
• Analysis and reporting

The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.

In Issue 26 of The Altascientist: 

• Introduction to standardization and its benefits
• Client considerations for nonclinical and clinical data standardization Case Study — Realized Efficiency
• Case Study — Realized Efficiency
• Case Studies — Legacy Data Conversion
• The future of CDISC and data strategy

The quality of study data depends on a rigorous sample management process that safeguards the integrity of samples at every step, from initial specimen collection through bioanalysis, to post-study storage. A CRO partner that conducts both preclinical and clinical studies, and supporting bioanalysis, ensures continuity of processes, knowledge sharing, and a centralized location for long-term storage of all your samples.

Issue 23 of The Altascientist provides a deep dive into: 

• sample collection and storage conditions
• standardized workflows for risk Management and chain of custody
• stability testing
• laboratory management
• customized processes
• management of bioanalytical matrices
• post-study sample management