Optimizing Drug Formulations for Successful First-in-Human Clinical Trials
Ensure a Smooth Transition from Formulation to Clinical Trials
Altasciences supports your formulation and drug development needs for preclinical safety testing, from discovery through first-in-human (FIH) clinical trials, for all dosage forms, such as oral liquids, powders, capsules, and injectables.
Our integrated approach combines formulation development, cGMP manufacturing and release testing, as well as clinical testing functions/workflows. One of the biggest benefits of this seamless offering is that our clinical trial teams work closely with the scientists involved in the formulation and manufacturing process, and are able to evaluate and optimize new formulations in the clinic, based on real-time human data. This collaboration and data sharing between our teams leads to shorter timelines, less risk, reduced costs, and improved flexibility.
Learn more about our expertise with both simple and complex formulation development, including those with highly potent APIs and solubility/bioavailability challenges.
| Scientific Journal | Q&A Video |
|
|
|
Questions? Speak with one of our experts.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Life Sciences Review: Altasciences—A One-Stop Solution for Accelerating Early Phase Drug Development
Altasciences Receives Accreditation From College of American Pathologists
Laval, Québec, October 31, 2022 – The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Altasciences’ clinical site in Los Angeles, California, based on results of a recent on-site inspection.
Altasciences was advised of this national recognition and congratulated for the excellence of the services being provided. Altasciences’ Los Angeles site is one of more than 8,000 CAP-accredited facilities worldwide.
“This prestigious accreditation is a testament to the high-quality work and oversight by Altasciences’ dedicated and passionate team in Los Angeles. We are pleased to give our clients the peace of mind that comes with working with a CAP-accredited biorepository, and are proud to have a seal of approval that reflects the quality of our work,” stated Dr. David Nguyen, General Manager and Medical Director at Altasciences’ Los Angeles site.
The CAP, first in the industry to offer an accreditation program for biorepositories, based the Biorepository Accreditation Program on the principles of its Laboratory Accreditation Program. The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal to, or more stringent than, the government’s own inspection program. Currently, there is no federal mandate for biorepository accreditation.
The CAP Biorepository Accreditation Program, a three-year accreditation cycle, includes on-site inspection, desk review, and optional education modules and gap assessment. As part of the on-site inspection, the CAP uses accreditation checklists to provide a comprehensive, up-to-date blueprint of quality practices to assist biorepositories in improving their operations and ensure quality. Further, a desk review offers a remote review of a biorepository’s quality management plan, certain procedures, and select quality and process statistics. The program is designed to ensure the highest standard of patient care.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing program, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP ANNUAL REPORT at cap.org.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Going Beyond the Science of Drug Abuse and Dependency
Opioid medications offer important benefits for pain management. They also have significant risks for abuse, dependency, and cognitive impacts. At Altasciences, we have leading-edge expertise in the scientific and clinical aspects of human abuse potential (HAP) evaluation, dependency assessment, and cognitive testing. We also devote significant time and resources to understanding the human behavioral elements of drug use, from recreational to abuse.
View the podcast series that takes a deeper look at the users behind the behavior, moderated by Dr. Beatrice Setnik, Chief Scientific Officer, and featuring Dr. Debra Kelsh, Psychiatrist and Principal Investigator at Altasciences:
- Trailer—The Many Face of Recreational Drug Use
- Episode 1—Introduction and interview with male, 30, opioid user
- Episode 2—Brief introduction and interview with female, 46, opioid use disorder
- Episode 3—Brief introduction and interview with male, 24, recreational poly-drug user
We seek to understand the genesis of the human story so that we can better influence the evolution, applying our expertise in opioid trials including HAP evaluation, driving simulation, abuse-deterrent formulations, and more, to this complex issue.
Selecting the Right Bioanalytical Platform for Your Molecule