BA/BE Studies
· Noah Therapeutics has an experienced clinical team comprising trained and experienced Doctors, Pharmacologists, Pharmacists, Science post-graduates, and graduates with extensive experience in clinical research.
· BA & BE Studies in Healthy Volunteers [OR] Healthy Subject BA/BE (Bioequivalence & Bioavailability) Studies
- Single dose BA/BE studies: Fast/Fed/Sprinkled applesauce
- Multiple doses BA/BE studies: Fast/Fed
- Steady-state studies
- Partial/full replicate/switch-ability design studies
- Parallel BA/BE studies
- Truncated BA/BE studies
- BA/BE studies for controlled psychotropic substances
- Long housing studies
- Comparative BA studies for different dosage forms/505(b)(2) submission types
- Food-effect studies
- Non-oral dosage form BA/BE studies:
- Injectable
- Topical products (semisolids, patch)
- Inhalation (oral/nasal) products: With & without charcoal
- Suppositories/Enema
- Vaginal route specific dosage forms
- Lozenges
- Special population BA/BE studies
- Post-menopausal female subjects
- Geriatric subjects
Bioanalytical Services
Noah therapeutics boasts a high-quality bioanalytical research department, headed by a highly experienced leader and a competent team. The department is equipped with all the standard methods that offer specialized support to drug developers in optimizing their drug candidates, assessing their safety and efficacy, and meeting the regulatory standards. The bioanalytical research team has the capability to handle and support various phases of drug development, from preclinical to clinical to post-marketing studies.
- Expertise in handling various metrics (plasma, serum, Urine & whole blood)
- Competencies to handle liquid-liquid extraction, solid-phase extraction and pre column/ post-column derivatization procedures
- Conjugate and non-conjugate drug level estimation
- Comprehensive list of assays
- Quick turnaround times
- Chiral separation of optical isomers
Quality Assurance
- At Noah Therapeutics, we uphold an unwavering commitment to excellence in Quality Assurance services. Our approach is characterized by precision, regulatory compliance, and a relentless focus on patient safety and data integrity. As stewards of scientific rigor, we navigate the intricate landscape of clinical research with finesse, ensuring that every facet of our operations aligns seamlessly with regulatory requirements.
Our independent quality assurance function stands as a sentinel, reporting directly to management. Within the confines of our state-of-the-art facilities, we meticulously oversee all in-house Clinical and Bioanalytical studies.
Rigorous sponsor audits serve as our litmus test, evaluating Noah Therapeutics against the gold standards of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
Our cadre of dedicated, qualified, and rigorously trained QA auditors execute their responsibilities with precision. They conduct internal audits, meticulously manage document control, and curate archival activities. Within our secure and fireproof Archival facility, nestled discreetly within the QA department, critical records find their sanctuary
Data Management and Statistical Services
- The team provides Data management services, Report writing and Regulatory submission services in best in class timelines in the industry.
- CDISC services
- Biostatistics or Statistical services
- Sample Size and Power Calculation
- Providing Statistical Inputs during Protocol Designing
- Medical writing and literature search
- Statistical Analysis Plan (SAP)
- SAS Programming and Validation
- Statistical Repor
Clinical Research
Services
- Project Management
- Medical and Scientific writing
- Site feasibility/ identification
- Site setup
- Clinical Monitoring
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NOAH Therapeutics respects the privacy of personnel and clients data and
ensures to protection of confidential information strictly.
