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Topical Drug Development: Important PK Considerations

Details: Drugs are typically applied to the skin when the skin is the desired site of action. In these cases, systemic absorption, where the drug penetrates beyond the layers of the epidermis to reach the bloodstream, is generally not desirable and can cause systemic safety concerns.

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5 Common Types of FDA Drug Applications: Quick Guide

Details: Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the branded product. 5. Over-the-Counter (OTC) Application. Over-the-counter (OTC) drugs are defined as drugs that are safe and effective for use by the general public without needing a prescription from a health

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Drug-Drug Interaction Studies: What is a Drug Interaction

Details: Drug-laboratory: drugs can interfere with lab tests by causing false positives or false negatives to occur; Drug-Drug Interactions. DDIs usually occur when a drug affects the expression or function of a metabolic enzyme or transporter. Since metabolism is the primary mechanism of elimination for most drugs, changes in the enzymes responsible

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What is Orphan Drug Designation

Details: The Orphan Drug Act of 1983 was designed to promote the development of drugs, biologics, devices, or medical foods that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. By definition, a disease or condition is classified as “rare” if it affects fewer than 200,000 people total in the United States, or if

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Pre-clinical Pharmacokinetics in Early Drug Development

Details: The main goal of the pharmacokinetic investigation in pre-clinical studies is to define the anticipated pharmacologically active drug level in the target compartment (eg. plasma or CSF). With this estimate, the safe starting dose and dose escalation scheme for the Phase 1 study can then be properly justified.

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Small Molecules vs Biologics Drug Development Differences

Details: Compared to biologics, small molecule drugs are relatively simple chemical compounds and can be manufactured by chemical synthesis. These compounds are typically comprised of 20 to 100 atoms and have a molecular mass of less than 1000 g/mol or 1 kilodalton [kDa]. The pharmacological activity, stability, and permeability of small molecules

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When to Use 505(b)(1) & 505(b)(2) Pathways for New Drugs

Details: While both 505 (b) (1) and 505 (b) (2) drugs require a full account of safety and effectiveness, the 505 (b) (2) pathway provides added flexibility for how this requirement is met. The purpose for this flexibility is to reduce unnecessary testing and to provide a way for follow-on products to make it to market more quickly.

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Intrinsic & Extrinsic Factors to Consider in Drug Development

Details: The interaction between food and drugs is a key concern for some types of medications, as some foods can alter the pharmacokinetics (PK) of certain drugs in a way that can affect patient safety and/or drug effectiveness. Grapefruit juice is a well-known example of a …

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What is Allometric Scaling & How to Use for Drug Development

Details: Content updated on October 06, 2021. There are many aspects of drug development that must be understood before a drug can be tested in humans. Nonclinical studies are conducted to understand the safety (i.e., toxicity and safety pharmacology) of drug candidates and to provide critical pharmacokinetic (PK) information, including insights into the drug’s absorption, …

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Importance of Steady-State Concentration in Drug Development

Details: Content updated on September 01, 2021. Steady-state concentration (C ss) occurs when the amount of a drug being absorbed is the same amount that’s being cleared from the body when the drug is given continuously or repeatedly.Steady-state concentration is the time during which the concentration of the drug in the body stays consistent.

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Drug Development for Infectious Diseases Nuventra

Details: The need to develop new drugs targeting infectious diseases has never been greater due to the rise of microbial and bacterial resistance and deadly viral diseases such as COVID-19. In 2019, the Centers for Disease Control and Prevention (CDC) estimated that each year in the US more than 2.8 million people are infected with antibiotic-resistant

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Pharmacokinetics & Pharmacodynamic (PK/PD) Services

Details: Pharmacokinetics vs. Pharmacodynamics. The main difference between pharmacokinetics and pharmacodynamics is that pharmacokinetics (PK) is defined as the movement of drugs through the body, whereas pharmacodynamics (PD) is defined as the body’s biological response to drugs. In other words, PK describes a drug’s absorption, distribution

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Is My Drug Exempt from an IND

Details: Use of drugs with radioactive or cold isotopes can be IND-exempt if they are used in basic research (e.g., metabolism, physiology, or biochemistry studies). For radioactive isotopes, use must be approved by a Radioactive Drug Research Committee ( RDRC ), must involve doses not known to cause pharmacological effects in humans, and must include

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Pharmacokinetic (PK) Parameters in Drug Development

Details: These complicated interactions are measured and described using pharmacokinetic and pharmacodynamic parameters. Pharmacokinetics (PK) describes the absorption, distribution, metabolism, and excretion (also known as ADME) of drugs in the body. Pharmacodynamics (PD) describes how biological processes in the body respond to or are impacted by a drug.

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COVID-19 Pandemic Impacts on Drug Development

Details: As stocks of experimental drugs sit idly in storage, it is likely that many will pass their established expiration dates. To overcome this, Sponsors may need to conduct additional stability testing to extend the expiration dates or may ultimately need to manufacture and test new drug batches.

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Marketing Exclusivity for Drug Developers: What is it

Details: For drugs that do not qualify as a NCE, if new clinical studies (other than bioavailability studies) are required for approval, then the product will still qualify for 3-year Clinical Investigation Exclusivity. This type of exclusivity is the most common …

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What is PBPK Modeling & Simulation in Drug Development

Details: What is PBPK Modeling & Simulation? Physiological based pharmacokinetic modeling and simulation (PBPK) is a computer modeling approach that incorporates blood flow and tissue composition of organs to define the pharmacokinetics (PK) of drugs. The concept of PBPK was first described by Teorell in 1937.

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BLA vs NDA: Regulatory Differences For Market Approval

Details: Drugs that are approved via an NDA pathway are regulated under Section 505 of the Food, Drug, & Cosmetics (FD&C) Act. A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.

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Food Effect Drug Studies Scientific & PK Considerations

Details: Overview. Food can change the rate of absorption and pharmacokinetics of drugs administered orally. The FDA requires the determination of food effect for most drugs. Pharmacokinetics (PK) is crucial to the success of this type of study. It is important to engage a pharmacokineticist during protocol development to devise a proper PK blood sampling schedule because of the …

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What is a Human Mass Balance (ADME) Study

Details: For drugs over the 10% threshold, a bioanalytical method will need to be developed for analyzing and pharmacokinetically assessing the metabolite (PK concentration vs. time and other PK parameters) in subjects of future clinical studies. It is not enough to characterize the parent drug if humans are exposed to significant amounts of a

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Benefits of The 505(b)(2) Pathway For Prodrugs

Details: In contrast, drugs using the 505(b)(1) pathway can take far longer to be approved and at significantly greater expense. Therefore, when possible, the 505(b)(2) pathway for prodrugs can remove major barriers that the original, parent drugs faced in the development process.

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What is the 505(b)(2) Regulatory Pathway

Details: Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration; Drugs with new active ingredients (in some cases) Drugs with new indications; New combination products; Prodrugs of an existing drug; Of note, biological therapeutics (also known as biosimilars) are not suitable for approval under the 505(b)(2

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Current and Future Therapeutic Options for COVID-19

Details: The list of new and repurposed drugs being investigated for possible treatment of COVID-19 is lengthy. As of January 2021, there are currently over 4,000 studies on ClinicalTrials.gov, including 173 vaccine studies, 1,387 drug studies, and 516 mapped drug names. Preclinical data and clinical trial results emerge for new experimental

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Drug Development for Metabolic and Endocrine Disorders

Details: While many drugs have been approved to treat metabolic and endocrine diseases, drug development challenges remain. For example, both hormones and the drugs used to modulate hormones can have effects throughout the entire body which is a primary concern.

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FDA Pre-IND Meeting Guide: Benefits & How to Prepare

Details: Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic products. This meeting, known as a pre-IND meeting, is intended to address specific questions related to the initial US clinical study (also known as a first-in-human [FIH] study for …

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Understanding Repeat Dosing & Steady-State Concentration

Details: Some drugs have quite prolonged half-lives (days to weeks, or longer). For drugs with extended half-lives, we may not be able to wait the necessary five half-lives to reach a desired steady-state concentration. When time is crucial (such as antibiotic use for critical-care patients), there is a method to achieve steady state more rapidly.

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Bioequivalence Studies & Abbreviated New Drug Applications

Details: Generic drugs play a significant role in modern healthcare by providing safe, effective, and lower cost alternatives to their corresponding brand-name drugs. Indeed, the profile of generic drugs has only increased in recent years, as public and political pressure across the ideological spectrum has mounted to help combat what some consider to

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Why Do Clinical Trials Fail

Details: Interestingly, the POS to get from Phase 3 to approval was only 59.0%. This means that around 2 out of every 5 drugs that reach Phase 3 “confirmatory” trials still fail to win approval for the indication being investigated. Even when looking only at lead indications, still about 30% of drugs in Phase 3 fail to reach approval.

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In Vivo Gene Editing Drugs Entered Clinical Trials in 2018

Details: 2018 saw the first in vivo gene editing drugs enter clinical trials. While a number of drugs can modulate the expression or activity of gene products at the RNA and protein levels, gene editing drugs act on the genome itself. Specifically, these drugs can add, delete, or replace specific segments of DNA, thereby offering the potential for

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Central Nervous System (CNS) Drug Development Nuventra

Details: For most neurological and psychiatric disorders, pharmacological targets are located in the central nervous system. This presents an obstacle for drug development because it is difficult to deliver drugs across the blood-brain barrier and it is challenging to measure drug concentrations in the central nervous system.

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In Vitro & In Vivo Drug Interaction Studies for NDAs & BLAs

Details: Drug interactions to consider for small molecule drugs include evaluation of a new drug’s potential to affect other drugs and the potential for the new drug to be affected by other drugs through metabolism-based interactions, transporter-based interactions, or combinations of multiple interaction mechanisms.

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Tissue-Agnostic Therapies & Drug Development in Oncology

Details: The FDA Oncology Center of Excellence was created in January 2017 and combines the experience of regulatory scientists and reviewers with backgrounds in drugs, biologics, and devices. The center successfully sped revolutionary approvals for two CAR T therapies, tissue-agnostic Keytruda, and next-generation sequencing tumor profiling, among others.

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Designing Clinical Trials for Elderly Populations Nuventra

Details: Some drugs are known to exhibit age-related differences and increased variability in pharmacokinetics (PK) and pharmacodynamics (PD), especially in people over the age of 75. Lower enrollment of elderly patients in clinical trials cannot support the risk/benefit assessments in terms of safety and efficacy of drugs intended for the elderly .

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Metabolites in Drug Development: What is a Metabolite

Details: Most drugs undergo some level of metabolism in the body. Understanding the activity and safety implications of key metabolites can be critical to the overall evaluation of the drug product. Because metabolites can confer pharmacological activity and possible toxicity beyond that of the parent drug, metabolism should be investigated early in a

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505(b)(2) vs 505(j) : Is a NDA or ANDA Right For Your Drug

Details: However, new drugs only account for a small portion of FDA approvals each year. In 2020, the FDA approved or tentatively approved 948 ANDAs, including 72 first generics and only approved 53 novel drugs, either as new molecular entities (NMEs) under NDAs, or as new therapeutic biologics under Biologics License Applications (BLAs).

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Drug Development for Pulmonary Diseases Nuventra

Details: Nuventras’s consultants have extensive experience developing drugs to treat respiratory disorders, as well as inhaled drugs intended to treat non-pulmonary diseases, across all stages of development. Nuventra’s Pulmonary Experience. Nuventra can perform any of our wide range of services for drugs to treat Pulmonary indications. Some of our

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CAR T-Cell Approval Challenges Manufacturing & Regulatory

Details: Like drugs that are eligible for accelerated approval, a drug must have preliminary evidence suggesting that it has the potential to address an unmet medical need to be designated as RMAT. Due to the strict requirements to qualify as RMAT, very few drugs have obtained this designation. B-Cell Malignancies & Solid Tumors

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Oncology Drug Development Nuventra's Services

Details: Oncology includes a spectrum of diseases that involve abnormal cell growth that can affect any part of the body. According to a report from the World Health Organization, cancer was the second leading cause of death worldwide in 2015, accounting for nearly 1 in 6 deaths.. Current pharmacotherapeutic options for cancer include not only traditional small molecule drugs, but …

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Hematology Drug Development Experience Nuventra

Details: Careful clinical trial design, including establishing appropriate dosages and endpoints, is important for the development of hematological drugs. For newer, more complex therapeutics (e.g., CAR-T cell therapies), innovative bioanalytical procedures must also be employed, along with specialized manufacturing and distribution techniques and controls.

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Drug Development for Rare/Orphan Diseases Nuventra

Details: Developing drugs for rare indications can also be financially challenging. The high cost of development coupled with a small patient population can result in a lower return on investment relative to indications with a larger potential patient pool.

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PBPK Modeling & Simulation Services for Drug Development

Details: Physiological based pharmacokinetic (PBPK) modeling and simulation uses computer modeling that incorporates physiologic and drug-specific parameters to characterize the pharmacokinetics (PK) of drugs. Recent improvements in computational capabilities and scientific advancements have led to increased use of PBPK models in drug development.

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Anesthesia Drug Development Nuventra Pharma Sciences

Details: Anesthesia broadly means a loss of sensation. Typically, anesthetics are used to prevent pain and other undesirable sensations. This function is distinct from that of analgesics, which are used to relieve pain, although certain anesthetics can exhibit analgesic properties. Anesthetics can be divided into three main classes: general anesthetics

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Analgesia Drug Development Experience Nuventra

Details: Aspirin and other nonsteroidal anti-inflammatory drugs, inhibit enzymes that are involved in the inflammatory response. Others, like opioids, bind receptors in the brain or elsewhere in the nervous system that are involved in sensing pain. Others operate by different mechanisms or by more than one mechanism.

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What is Quantitative Systems Pharmacology (QSP)

Details: Quantitative systems pharmacology (QSP) is an exciting and powerful convergence of biological pathways, pharmacology, and mathematical models for drug development. QSP has the potential for delivering significant impact to modern medicine through the discovery and utilization of new molecular pathways and drug targets in the pursuit of novel therapeutics and individualized …

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Drug Development for Pediatric Diseases Nuventra

Details: While these diseases represent a substantial public health concern, most drugs have traditionally been developed and approved only in adults. In an effort to promote the development of drugs for pediatric use, the US Congress passed the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act . Together, these laws require

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Drug Development for Dermatology Nuventra Pharma Sciences

Details: Drug Development for Dermatology. Dermatology is the branch of medicine dealing with the skin, nails, hair, and its diseases. The skin comprises the body’s largest organ and performs a variety of vital functions. It allows for temperature regulation, prevents dehydration, facilitates touch, temperature, and pain sensations, and even makes

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Understanding Hepatic Impairment & PK Nuventra

Details: The liver is responsible for the metabolism and clearance of many different drugs and their metabolites. Because of the liver’s importance in removing drugs from the body, diseases or injuries that impair liver function (hepatic impairment) can affect how some drugs interact with the body.In particular, the pharmacokinetics (PK) of the drug may be altered in a way that …

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Drug Development for Women's Health Nuventra Experience

Details: Nuventra has extensive experience in developing drugs to treat indications specific to women’s health. Our co-founder, Bill Wargin, Ph.D., served as a Pharmacokineticist for the clinical development of multiple compounds to treat breast cancer, vaginitis, and vulvovaginal conditions. In addition, Nuventra’s team of consultants has supported

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How to Prepare for a Pediatric Study Plan Submission

Details: Orphan designation applies to drugs or biologics that are intended for a disease or condition that affects less than 200,000 people in the United States. However, some exceptions apply. On August 18, 2017, the RACE for Children Act was incorporated as Title V of the 2017 FDA Reauthorization Act (FDARA) to amend PREA.

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