BA / BE SERVICES
Backed by excellent scientific expertise with capabilities of handling challenging studies, SRPL’s Bioavailability/Bioequivalence Studies offer global access to 100+ clinical beds. Robust recruitment & housing options enable us to provide customized sponsor/study requirements.
BA and BE Studies :
- Solid oral formulations [Tablets (Immediate release & modified release, e.g., ER, DR, SR), capsules, soft gels, sprinkles, etc.]
- Parenteral formulations
- Topical transdermal products (Patches, Cream, Ointments, Solutions)
- Inhalation
- Nasal and oral sprays
- Rectal products (Suppository & foam)
- Vaginal products (Tablet, cream, gel)
- Long acting injectable
Types of Studies
- Experience of handling FTF & time-sensitive studies
- Performed studies for injectable, rectal suppositories, urine PK studies, oral DDS, local applications, inhalations, etc
- Short to long residency studies, oral inhalation - Pulmonary deposition & therapeutic equivalence study, pharmacokinetic interaction studies, intravenous anesthetic drug BE study (e.g., Propofol) & glucose clamp studies
- Dose-Proportionality studies & first-in-human studies (Phase-I trials)
Pharmacokinetics (PK) Studies :
With our wide range of services, we provide project planning to build quality into PK studies from the start – with risk-mitigating strategies, efficient and effective time and budget planning, and optimizing performance. The team has experience working with the risk management plan, safety management plan, QA audit plan, IMP plan, data management plan, edit check plan, monitoring plan, project management plan, and PK sample management plan. The team is trained thoroughly to execute all these plans. Most importantly, the project managers are always prepared with a risk mitigation plan for unforeseen conditions that may occur during a PK study.
Clinical End Point Studies :
Our clinical endpoint studies monitoring services include study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse events reporting, regulatory compliance monitoring, and regulatory documentation maintenance.
Project managers provide solution-focused project management across our studies. They are a single point of contact, expertise in therapeutic equivalence studies. They provide meaningful insight into your recruitment challenges, evaluate the impact of competitive trials, and optimize patient access and retention.
They provide accountability and transparency with a proven track record of successful delivery. Timelines and risks are managed proactively, applying knowledge from past experiences to ensure efficient study management.
We have a vast database of investigators and site associations to ensure rapid identification of potential investigators and their patient populations to help ensure enrolment goals are met. We also train investigators and site teams on protocol requirements, industry best practices, and technology tools, such as electronic data capture.
Pharmacodynamic Evaluation :
The pharmacodynamic method is the direct way of conducting bioequivalence study to assess the physiologic and biochemical impact of drug product on a living organism. The pharmacodynamic study is divided into uses two methods for bioequivalence evaluation, therapeutic, and acute pharmacological response. In the therapeutic evaluation, assessment is done for the relationship between the clinical response when the drug concentration moves to the site of action (or reacts to the symptoms it intends to cure). In the acute pharmacological evaluation, the impact of the drug dosage and concentration on ECG, pupil diameter, EEG, etc., are tested and measured.