Latest Blogs
Recruitment of Study Participants Is Vital to Phase 1 & 2 Clinical Trial Success
The recruitment and retention of study participants are essential for the success of clinical trials, including Phase 1 clinical trials and 2 studies. Unfortunately, many clinical trials are unable to recruit a sufficient number of study participants to ensure...
Dose proportionality: a critical element in drug development and patient therapy
In pharmacokinetics, the term dose proportionality is commonly used. If a drug product exhibits dose proportionality, there will be a proportional increase in the amount of drug reaching the systemic circulation, usually expressed in the exposure such as AUC or Cmax,...
Clinical Research Spotlight: Ketamine, Norketamine and Hydroxynorketamine
Ketamine is a precipitation drug that was developed in the 1960s and approved as an anesthetic. Ketamine has been used on the battlefield to treat injured soldiers in the Vietnam War, in pediatric sedation, and is a medicine widely used in veterinary anesthesia. In...
Our Niche: How Early-Stage Clinical Trial Expertise Delivers Better Client Solutions
The process of clinical drug development is complex and associated with high costs and risks. A recent report on drug development found that the overall likelihood for approval of Phase 1 developmental candidates was 7.9% for the time period between 2011 and 2020, and...
How the end-to-end approach of a full-service clinical research organization (CRO) addresses human clinical trial challenges
Drug discovery and development are crucial to introducing novel therapeutics in clinical practice, and the research in these fields is intensive. In 2020, the Center for Drug Evaluation and Research at the Food and Drug Administration approved 53 novel therapeutics,...
BioPharma Offers Renowned Human Abuse Potential (HAP) Studies and Abuse Deterrent Expertise
Human abuse potential (HAP) studies, also known as human abuse liability testing, have gained relevance as the FDA becomes increasingly interested in knowing whether or not new drugs could be misused for recreational purposes. Dr. John Oldenhof, Ph.D., Chief...
How to Conduct Human Clinical Trials
Learn about all aspects of Human Clinical Trials Click to jump to a section: The Importance of Human Clinical Trials Frequently Asked Questions (FAQ's) About Human Clinical Trials The Phases of Human Clinical Trials Conducting a Human Clinical Trial With BioPharma The...
Spotlight On Renzo DiCarlo, CEO: Leading a clinical trial services company with Character and Resilience
In his 10 years with BioPharma Services, Inc. CEO and board member Renzo DiCarlo has led the clinical trial services company to grow into a thriving contract clinical research organization (CRO) conducting clinical studies across all medical disciplines, specializing...
Conducting Complex Clinical Studies Involving Speciality Services: an Interview with Louis Co
In 2003, when the global outbreak of Severe Acute Respiratory Syndrome (SARS) hit Canada, Louis Co was employed as a nurse in a hospital and a clinical research facility in Toronto. Together with his team of colleagues and physicians, they instituted new protocols to...
When is 505(b)(2) a Good Choice for Your New Drug Application?
Whether you need a study to establish a new indication for a small molecule or investigate a novel route of delivery for a previously approved drug, BioPharma can provide the services you need and guide you through the appropriate regulatory pathways.
Biostatistics and Data Management Key to Clinical Trials
At BioPharma Services, our talented biostatistical analysis, data management, and programming teams provide support to clients conducting clinical trials in our Clinic, as well as to Sponsor companies requiring dataset analysis of external studies.
IVIVC modelling can speed up the drug development process
IVIVC can serve as a surrogate for human bioavailability, bioequivalence studies and speed up the drug development process Want to have a certain confidence in the potential drug release of your product during your product development? An in vitro in vivo correlation...
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