Frequently Asked Questions (FAQs)

Click through some of our FAQs. If you need further clarification, or have a question we haven’t answered below, please contact us using the form at the bottom of the page. A member of our team will respond to you quickly.

What type of studies do you support?

Clinical pharmacology studies supported by Nuventra include

  • First-time-in-humans (FTIH)
  • Single ascending dose (SAD) and multiple ascending dose (MAD)
  • Bioavailability (BA) & bioequivalence (BE)
  • Dose ranging
  • Food Effect
  • Drug-drug interaction (DDI)
  • Special populations (hepatic and renal impaired and elderly, etc.)
  • Cardiac conduction (thorough QT or TQT)
  • Mass balance radiolabeled
  • Site absorption
  • Pharmacokinetic – Pharmacodynamic (PK/PD) relationships
  • Pharmacokinetic and Pharmacodynamic assessments in Phase 2 and 3

Do you “analyze” PK samples collected from subjects in a clinical study?

While we do not collect or analyze biological samples in a laboratory we do “analyze” PK data using computer software to determine the pharmacokinetic parameters of drugs such as half-life.  Biological samples (e.g., blood) from clinical studies are collected by a third-party clinical unit not affiliated with Nuventra and sent to a third-party bioanalytical laboratory (also not affiliated with Nuventra) for analysis of drug concentration in each sample.  The resulting drug concentration data generated by the bioanalytical laboratory are the starting point of Nuventra’s PK analysis.  We use computer software to determine the pharmacokinetic fingerprint (i.e., PK characteristics or PK parameters) for each drug (e.g., half-life, maximum concentration [Cmax], time to maximum concentration [Tmax], clearance, volume of distribution, etc.).  We are experts at noncompartmental, compartmental traditional (rich sampling) PK analysis using validated PK/PD software as well as population PK analysis (sparse sampling) using NONMEM.

Do you work with late stage clinical studies (Phase 2 and 3 studies)?

Yes, we work with clients that have compounds in late stage development.  Late stage studies often require population PK strategies.  Nuventra can work with clients to set up clinical studies properly from a population PK perspective as well as analyze the data after the study is completed.

Do you work with nonclinical (animal and in vitro) models?

Yes, we assist clients with nonclinical studies and analysis.  Nuventra can perform GLP and non-GLP toxicokinetic analysis of data from nonclinical studies.  Also, Nuventra will assist clients in selecting and managing nonclinical vendors and provide advice related to transporters and in vitro cytochrome (CYP) 450 interactions that can influence human trials.  Nuventra can also summarize nonclinical data for regulatory submissions such as an IND.

Our nonclinical experience comes from a variety of sources including the authoring of sections within regulatory documents (INDs, NDAs, briefing packets, Investigator Brochures, etc.) related to pharmacology (primary, secondary, and safety pharmacology), in vitro and in vivo drug metabolism and pharmacokinetics, toxicokinetic, and toxicology.

Can you work remotely on our project?

Nuventra offers a number of virtual models that allows us to work remotely on almost any project.  Employing teleconferences, video conference, and web-based file sharing services, Nuventra can meet the needs of client requests without an onsite presence.  We are also available if needed for onsite interactions.  We work with companies all over the globe.

Do you have SOPs?

Yes, we have a full complement of SOPs for conducting PK analysis, writing PK reports, writing clinical study reports with PK data, and other SOPs related to ensuring quality on our projects. Also, we have multiple “Working Practice” guidelines for conducting our business operations.

Do you have regulatory affairs experience

Yes, we have extensive regulatory affairs experience related to clinical pharmacology and PK.  We regularly attend meetings with the FDA for clients (e.g., Pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings).  We are familiar with the regulatory guidance documents for clinical pharmacology and PK and also understand the current environment at the FDA related to clinical pharmacology and PK topics across many different therapeutic areas.

Nuventra personnel have had numerous interactions with FDA (CDER and CBER) across multiple Divisions and are experienced in determining issues of critical importance to FDA and advising clients on appropriate strategies to meet the challenges. Division within CDER for which we have interacted with include the Divisions of Anesthesia, Analgesia, and Addiction Products (DAAAP), Metabolism and Endocrinology Products (DMEP), Pulmonary, Allergy, and Rheumatology Products (DPARP), Cardiovascular and Renal Drug Products, Gastroenterology, and Neuropharm. Offices for which we have interacted with include the Offices of Hematology Oncology Drug Products, Orphan Products, Nonprescription Products (OTC). The combined regulatory experience of our consultants includes efforts on approximately 50 IND projects and 20 NDAs. Our collective exposure to FDA has included participation in over 75 meetings with the Agency across diverse projects and therapeutic areas and Divisions. Regulatory writing experience spans large numbers of Investigator brochures, clinical study reports, clinical protocols, meeting briefing packets, IND annual reports, IND safety reports, etc.

Do you work with transporters and cytochrome (CYP) 450 assays?

Yes, we provide advice to clients regarding their need to conduct transporter and CYP P450 assays.  We include this type of analysis in our clinical pharmacology plan service which looks at all factors that might influence the human clinical development strategy.

Do you conduct clinical studies?

While we do not have a clinic to dose patients, we help clients run a Phase 1 study based on scientific and PK principles.  We provide strategic advice on clinical study design and protocol construction related to optimizing the collection of samples for pharmacokinetic analysis.  We also advise clients on the selection of clinical research units (CRUs) and assist with managing the CRUs during the conduct of the study.

Do you have a clinic or lab?

We don’t have a clinic to collect PK samples or a bioanalytical lab to measure the concentration of drug in PK samples.  We partner with leading groups to help clients run clinical studies at third-party clinics and labs.  We are experts at analyzing the drug concentration data from a clinical study to determine the PK fingerprint (i.e., PK characteristics or PK parameters) for each drug such as half-life and maximum concentration after dosing.

“I need PK help in a particular therapeutic area/disease state.”

Nuventra has broad and extensive experience in a multitude of therapeutic areas and understand the importance of clinical pharmacology/pharmacokinetic strategies within each area. We also have a complete understanding of the regulatory environment associated with each therapeutic area as related to clinical pharmacology/pharmacokinetic strategies.

Chances are good that we have worked in your therapeutic area of interest. Learn more.

For more details please submit a request either through the no sales pitch page or quote page

“I need a clinical study protocol written.”

Nuventra has an extensive library of clinical pharmacology study designs, including special patient population studies (e.g., renal impaired, hepatic dysfunction, healthy elderly, thorough QT [TQT], radiolabeled mass balance, ADME studies, etc.) from which to develop study protocols.

In particular, we are experts at designing studies and developing protocols that are concise, well written, operationally friendly, and designed to meet the objectives of the study. In addition, our pharmacokineticists provide their extensive experience with designing studies to meet pharmacokinetic endpoints and produce robust PK and PD data sets.

For more details please submit a request either through the no sales pitch page or quote page.

“I need a clinical study report written.”

Nuventra’s consultants have many years of experience developing clinical study reports for submission to the FDA and other regulatory agencies. We have robust medical writing and QC SOP’s in place to insure consistent and high-quality reporting. Clinical study reports written by Nuventra Pharma Sciences include the type of perspective that only seasoned clinical pharmacology consultants and pharmacokineticists can bring to the table.

For more details please submit a request either through the no sales pitch page or quote page.

“I’m filing an IND or NDA and need help with the clinical pharmacology sections.”

Nuventra supports full IND preparation and maintenance, as well as targeted efforts on clinical pharmacology, human PK/PD, and nonclinical ADME and toxicokinetic sections of INDs and NDA/BLA’s. Having a pharmacokineticist at least review sections of your IND or NDA is simple but may bring significant added value to your submission by adding the type of perspective that only a seasoned pharmacokineticists can bring.

More info on regulatory submissions.
More info on medical writing experience.

“I’ve got a meeting with the FDA and need clinical pharmacology support.”

Nuventra has extensive regulatory affairs experience related to clinical pharmacology and pharmacokinetics. We are familiar with the regulatory guidance documents for clinical pharmacology and PK and also understand the current environment at the FDA in this area of drug development across many different therapeutic areas. We regularly attend meetings with the FDA for clients (e.g., Pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings). Our Executive VP of Pharmacokinetics, Dr. Bill Wargin, has attended over 50 meetings with the FDA as a clinical pharmacology and PK expert and was an expert reviewer for the Biopharmaceutics Branch of the FDA.Click here to learn more about our regulatory affairs experience.

“I’m writing a phase 1 protocol and need some PK advice about PK endpoints and sampling schedule.”

Designing a rational PK sampling schedule based on nonclinical data, PK, PD modeling, or prior human data, is critical. This may seem like common sense, but it is frequently not a significant consideration and not optimized. Our pharmacokineticsts will be able to quickly evaluate a particular drug and make recommendations regarding the starting sampling schedule for your clinical study. There is a fine line between obtaining too few samples and too many, but if there is one place not to cut costs it is related to having an adequate PK sampling schedule. Keeping subjects in a study for one or two more days beyond original expectations to collect additional PK samples could help better define the terminal phase and produce an overall better data set. Nuventra provides rapid review and turnaround of a clinical study PK sampling schedule at minimal cost.

For more details please submit a request either through the no sales pitch page or quote page.

“I have concentration data from a clinical study for which I need PK analysis (Cmax, Tmax, t1/2, etc.).”

Nuventra uses intelligent PK strategies to position drug development programs for success. Our extensive experience with analyzing PK data and interpretation of results is unmatched in the industry. Our experience and services includes:

  • Robust pharmacokinetic, pharmacodynamic, and PK/PD analysis of data in a validated environment using industry standard validated software;
  • Authoring integrated Clinical/PK/PD study reports or standalone PK/PD reports;
  • Preclinical ADME and human studies;
  • Toxicokinetic input into toxicology studies and TK data analysis and report writing; and
  • Data management services for PK data to ensure compliance with current CDISC standards.

Click here for more details or please submit a request either through the no sales pitch page or quote page.

“I have a working knowledge about PK and just want some back-up.”

Nuventra has developed a series of virtual resources for rapid and efficient delivery of strategic guidance to clients for their pharmacokinetic and general clinical pharmacology needs. Nuventra has launched a PK help desk for quick feedback to clients and a virtual PK group model to handle more in-depth issues and topics. Overall, Nuventra’s services provide rapid access to our extensive technical expertise in drug development and complete understanding of clinical pharmacology from a pharmacokinetic, scientific, regulatory, and clinical conduct perspective.

For more details please submit a request either through the no sales pitch page or quote page.

“I need help quickly and just want to speak with a consultant or pharmacokineticist”

For people who just want to obtain information about Nuventra or need help now then please contact us as listed below! We want to break down the barriers that can delay your drug development programs and provide the type of advice that you need…..fast.

Let’s start the conversation. Click Here

Or you can call 1-888-615-5111 or email us at discover@nuventra.com

We will follow-up with you within 24 hours.

“I want to access the PK Help Desk”

We have a rapid confidential agreement process and simple consulting contract designed specifically for providing quick access to the PK Help Desk.

Alternatively, if you just need to chat with one of our pharmacokineticists and clinical pharmacology consultants then we offer access through our “Need Help Now” approach.

Please submit your information either through the help now page or quote page

Or you can call 1-888-615-5111 or email us at discover@nuventra.com

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