Humphrey Tebit, Founder and Clinical Research ConsultantPharma companies, however, still face numerous challenges while conducting clinical trials for their molecules or compounds and finding the right analysis method to get market approval.
HT Pharmaceuticals is a leading Clinical Research Consultancy supporting the full range of clinical study activities, from conception to market introduction.
“We handle a pharmaceutical product from initial stages to the point when the client finalizes their molecule and wants to advance to registration in Canada, the U.S., Europe, or other parts of the world,” says Humphrey Tebit, founder and Clinical Research Consultant of HT Pharmaceuticals.
HT Pharmaceuticals is built upon Tebit’s three decades of domain experience. It excels in determining study feasibility and design, liaises with regulatory bodies, ensures ethical compliance, and creates submission packages for health authorities, ultimately securing product approval for market release.
Providing End-To-End Support
For small and mid-sized pharma companies that usually lack the facilities to conduct inhouse studies, HT Pharmaceuticals selects CROs based on their relevant experience. It evaluates cost quotations, consults with pharmaceutical clients, and finalizes the most suitable CRO for the study.
Prior to and following the CRO selection process, a feasibility plan is developed to enhance the regulatory-compliant study design. This involves the signing of project and service agreements and the tailoring of standardized CRO protocols to align with jurisdiction-specific requirements. Thorough and ongoing communication with the chosen CRO is established to ensure the development of a protocol that meets the criteria for submission to the relevant authorities. Subsequently, subject panels are meticulously assembled based on the study's predetermined sample size requirements. These studies exhibit a diverse range of designs, spanning from two-way crossover studies to parallel group study designs.
Once authorized, HT Pharmaceuticals works with the CRO to begin screening study subjects while ensuring protocol adherence. This involves collecting blood samples for medical screening, implementing clinical periods with a drug-free washout duration, and then dosing subjects again in the next period.
HT Pharmaceuticals reviews the clinical research forms to gather data in accordance with the approved protocol. These details ensure the subjects meet the inclusion and exclusion criteria set by the study design.
Focusing on Pharmacokinetic Parameters Studies
Bioequivalence studies, focusing on pharmacokinetic parameters, are crucial for confirming the equivalence of two products, typically generic and innovative drugs. Meeting strict area under the curve (AUC) and CMAX criteria in four to six-month studies allows for submission and approval in the respective jurisdiction—a service frequently provided by HT Pharmaceuticals.
To address high variability in certain drugs, it employs a fully replicated four-way study approach. Subjects receive doses across four periods in alignment with the drug's characteristics and distinct regulatory standards. This approach promotes compatibility with product variability, pharmacology, and pharmacokinetics, enhancing the study's effectiveness.
We handle a pharmaceutical product from initial stages to the point when the client finalizes their molecule and wants to advance to registration in Canada, the U.S., Europe, or other parts of the world
The company’s extensive data analysis and interpretation expertise fosters an accurate understanding of study results. This proves invaluable in reaching wellfounded conclusions, particularly for small companies looking to expand their product portfolios.
Guiding Pharmaceutical Companies to Success
In its nearly 15 years of operation based on a 30 years of experience of its founder, HT Pharmaceuticals has garnered a reputation for quality and client satisfaction. The company's dedication to serving the pharmaceutical industry, regardless of the type of product, is apparent in its meticulous approach to each phase of the clinical trial management process.
Its team of seasoned experts ensures that the studies they manage adhere to the highest standards of integrity, accuracy, and regulatory compliance. Their extensive experience in Europe and North America gives them a global perspective that adds unparalleled value to clients.
Biopharmaceutics Classification System (BCS)- Based Biowaivers Drugs
For drugs that meet the BCS criteria where studies are not required and a biowaiver approach can be used, HT Pharmaceuticals puts together strong scientific rationale backed by literature references to be incorporated into a submission package. Approvals from such drugs is a testament to HT Pharmaceuticals scientific expertise.
HT Pharmaceuticals is not just a company in the clinical trial management business; it is a partner that guides pharmaceutical companies through the intricate process of bringing a new drug to market. From the earliest stages of molecule review to final data analysis, its dedication to excellence shines through. As the pharmaceutical industry continues to evolve and meet new challenges, HT Pharmaceuticals remains a beacon of expertise and reliability, guiding pharmaceutical companies to success in a dynamic and demanding market
