Pharmaceutical Statistics

Regulatory Query
Statistical Consulting

In-Vitro Convolution
Modelling

Dissolution Similarity
Statistical Analysis

Population Bioequivalence
Statistical Support

Peer Review of Previous Studies
for a Successful New Trial

1. Regulatory Query Statistical Consulting

At PHARMA-STATS, we deliver end-to-end statistical support for regulatory queries, backed by over 20 years of expertise. We’re here to help you navigate the complex regulatory landscape with confidence. Our services are tailored to handle diverse regulatory challenges, from formulation dissolution similarity to advanced analytical queries, clinical trial studies, and both bioequivalence and population bioequivalence.

Read More Read Less

2. In-Vitro Convolution Modelling

At PHARMA-STATS we use mathematical models to convert in-vitro dissolution data into a form that mimics in-vivo pharmacokinetics, effectively allowing researchers to understand absorption rates, bioavailability, and overall drug efficacy without the need for early-stage human trials.

Read More Read Less

3. Dissolution Similarity Statistical Analysis

Choose PHARMA-STATS for dissolution similarity analysis that combines statistical rigor with proven regulatory success, ensuring your drug formulations are optimized and ready for approval for biowaivers.

Successful Regulatory Query Responses

We have an outstanding track record, for successful regulatory query responses for the EMA and MHRA. This expertise showcases our proficiency in handling complex statistical analyses and addressing stringent regulatory requirements, making us your trusted partner for regulatory submissions.

Purpose: To assess and confirm that two drug formulations exhibit similar dissolution profiles, ensuring consistent therapeutic efficacy for biowaiver of strengths in accordance with FDA, EMA, and other regulatory guidelines.

Method (as per Guidelines) :

f2 Similarity Factor.
Model Independent Approach using a similarity factor (f1 and f2) (Mahalanobis Distance (MD)).
Model Dependent Approaches (Weibull, Logistic, Probit etc).
Bootstrap Approach.

PHARMA-STATS Role :

Expert Application: We employ advanced statistical techniques for precise dissolution similarity assessments as per latest guidelines and regulatory acceptance.
Regulatory Compliance: Our team prepares analysis, reports that meet regulatory standards, ensuring seamless acceptance by authorities like the FDA, EMA, and MHRA.
Customized Analysis: Tailored R- software based solutions for different formulations and products, ensuring accurate comparisons.

Benefits of PHARMA-STATS:

Regulatory Assurance: Over 70 successful regulatory query responses, demonstrating our effectiveness in addressing concerns till date (October 2024).
Accuracy and Precision: Detailed and comprehensive analysis using the most robust statistical methods, interpretation and justifications.
Time & Cost Efficiency: Streamlined analysis process, reducing the need for additional testing and speeding up approval.

Why Choose PHARMA-STATS?

Proven Expertise: Extensive experience with global regulatory submissions, ensuring your submission of project or regulatory query response meets all requirements.
Advanced Tools & Techniques: Utilization of cutting-edge statistical R-software and methodologies.
End-to-End Support: Comprehensive guidance from data analysis to regulatory response, ensuring a smooth approval process.

Read More Read Less

4. Population Bioequivalence Statistical Support

Purpose:

PHARMA-STATS ensures that all PBE analyses strictly adhere to these OGD guidelines, providing accurate, validated results that support the regulatory approval process. This rigorous approach ensures the safety, efficacy, and consistency of generic drugs, thereby facilitating their acceptance by regulatory agencies.

Read More Read Less

5. Peer Review of Previous Studies for a Successful New Trial

By partnering with PHARMA-STATS for peer review, you gain a trusted ally that helps turn past failures into stepping stones for success, ensuring your future clinical trials or bioequivalence studies are scientifically robust and ready for regulatory approval.

As your consultant, PHARMA-STATS offers expert guidance and statistical oversight, ensuring every aspect of your study meets high standards of integrity and compliance, making your path to approval smooth and confident.

Purpose

To elevate the scientific quality and reliability of failed or pilot studies, turning them into successful clinical trials or bioequivalence studies.

Method (Review Process)

Study Design Evaluation: Assessing whether the study design is robust and efficient.
Statistical Methods Assessment: Reviewing the statistical models, sample size calculations, and analysis techniques to ensure methodological accuracy.
Data Integrity Check: Verifying data accuracy, consistency, and completeness, addressing gaps that might impact regulatory acceptance.
Result Interpretation: Offering comprehensive insights into study outcomes to ensure validity and provide actionable recommendations for future studies.

PHARMA-STATS Role as Your Biostatistical Consultant

Biostatistical Consultancy for CRO Sites: We partner with pharmaceutical manufacturers as a biostatistical consultant, offering independent reviews of clinical trial projects conducted at CRO sites. This collaboration ensures studies meet the highest quality standards and regulatory expectations from biostatistical & data point of view.
Detailed Analysis & Recommendations: Our experienced biostatisticians perform meticulous evaluations, offering actionable feedback to refine study methodologies and results.
Ensuring Regulatory Compliance: We assist clients in aligning their studies with regulatory requirements, ensuring a smoother path to approval.

Benefits

Independent Expert Review: Our role as biostatistical consultants ensures unbiased, high-quality assessments of ongoing clinical trials.
Transforming Failures into Success: We turn unsuccessful trials into valuable learning experiences, guiding you toward successful outcomes.
Regulatory Readiness: Comprehensive support to ensure studies meet stringent regulatory standards with actionable insights and corrections.

Why Choose PHARMA-STATS?

Experienced Biostatistical Consultant: We have a strong history of working with pharmaceutical manufacturers, providing independent and insightful reviews at CRO sites.
Proven Expertise: Our skilled biostatisticians offer thorough, accurate, and tailored peer reviews.
Customized Solutions: Providing feedback and strategies to enhance study designs, methodologies, and outcomes.

Read More Read Less