Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within pharmaceutical development to quickly assess stability characteristics, especially to understand mechanisms of degradation. These modeling tools provide stability insights within weeks that could take months or years to understand using long-term stability

The comparison of quality attributes is a key element in the evaluation of both biosimilars and manufacturing process changes for biological medicines. Different statistical approaches are proposed to facilitate such evaluations. However, there is no regulatory consensus on a quantitative and scientifically justified definition and an underlying hypothesis of a statistically equivalent quality. The

It is the right of all humans to have access to safe, quality and effective medicines. This article seeks to expound on the problems of drug manufacturing and challenges of accessing medicines in West Africa, and evaluate the strategies being adopted by international developmental partners and the governments to address them. West Africa is uniquely diverse in culture (having English, French and Portuguese

Substandard and falsified medicine screening technologies are invaluable tools for post-marketing surveillance of medicine quality, particularly in low- and middle-income countries. National Regulatory Authorities and their partners leverage screening technologies to detect substandard and falsified medicines in the field and eliminate them from the medical product supply chain. An arsenal of different

Potassium chloride (KCl) syrup is widely used for the oral treatment of the hypokalemia. However, it is associated with unacceptable taste. In the present study, we sought to develop a palatable and easy to reconstitute KCl dry syrup as a commercially viable alternative to currently available KCl syrup. We explored the potential of Eudragit E100 as a taste-masking polymer to coat and improve the palatability

Brazil, the largest country in South America, has become the second largest pharmaceutical market in the emerging world. The Brazillian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA) was created in 1999 with the primary goal to protect and promote public health surveillance over products and services in Brazil. The governing body and structure of this new regulatory

Since its inception in 1986, the American Association of Pharmaceutical Scientists (AAPS) has grown to be one of the premier scientific societies for pharmaceutical scientists in industry, academia, government, and other institutions in North America, with a global outreach to scientists from more than 60 countries around the world. Due to the foresight of its founders, AAPS established itself as a

Auto-injection devices must be easy and intuitive to use, especially in emergency situations. However, there are many reports of safety-related issues affecting auto-injectors and pen injectors, due to usability deficits. To minimize this type of problem, the identification of potential use errors is an important and critical task in usability engineering. The aim of this systematic, qualitative literature

Therapies based on monoclonal antibodies (mAbs) have delivered an impressive success in the clinics due to their exquisite specificity, potential for agonistic or antagonistic responses, tunable effector function, and optimal pharmacokinetic properties. Building on these inherent antibody properties, the design and development of antibody-drug conjugates (ADCs) with improved or gained therapeutic activity

Highly selective drug targeting is an important goal in the development of cancer nanotechnologies. In an effort to improve tumor targeting a method was developed to formulate cell membrane lipid-extracted nanoliposomes (CLENs). The main ingredients were extracted directly from the membrane of cancer cells. For this study we used three different breast cancer cell lines (4 T1, BT-20, and SK-BR-3).

Regulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and efficacious products quickly to patients. APEC established the Regulatory Harmonization Steering Committee (RHSC) to advance this cause among member economies. This paper identifies four areas of appropriate regulatory practice in which APEC

Fingolimod is an oral agent approved for the treatment of relapsing forms of multiple sclerosis (MS), which has demonstrated efficacy in Phase III trials in patients with relapsing-remitting MS (RRMS). The present study was designed to assess bioequivalence between a fingolimod Test capsule formulation (Teva Argentina, formerly IVAX Argentina S.A.) and a Reference capsule formulation (Novartis Pharma

An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD. Seventeen subject matter experts (SME), from industry and the Food & Drug Administration (FDA)

Inotuzumab ozogamicin (InO) is an antibody-drug conjugate composed of a recombinant, humanized immunoglobulin type G, subtype 4 (IgG4) antibody covalently bound to a semisynthetic derivative of calicheamicin via an acid-labile linker. It was developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). Based on the perceived relatively low

While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience medications in real world settings. However, the relationship between these two data sources has not been closely examined. To understand how rates of medication side

Biorelevant dissolution is an indispensable tool utilized during formulation development and optimization for the prediction of in vivo bioavailability of pharmaceutical agents. Within that framework, membrane-permeation dissolution methodologies are widely used to model drug absorption. The current work evaluates polymer membrane surface modifications for production of biomimetic membranes to be employed

There has been significant growth in the use of modeling tools to accelerate development and enhance pharmaceutical quality. Among these are empirical and semi-empirical modeling of accelerated stability studies which can be used to predict product shelf-life (Waterman, Pharm Res 24:780–790, 2007; (Wu et al., AAPS Pharm Sci Tech,16:986–991, 2016); (Lavrich, Rapid Development of Robust Stability Models

The University of Wisconsin-Madison June Land O’Lakes Conference on Research and Development is held every year and is recognized worldwide as a premier teaching conference for pharmaceutical scientists. The conference held in June 2016 was a tribute to the ground-breaking work of Emeritus Professor and Dean George Zografi of School of Pharmacy, University of Wisconsin-Madison. This paper provides

Candesartan cilexetil is an ester prodrug antagonist to angiotensin II receptor type 1 (AT1) used in management of many cardiovascular diseases. The absolute bioavailability of candesartan cilexetil is about (14–40%). Therefore, the paper aim was to prepare and evaluate solid self-nanoemulsifying drug delivery systems for candesartan cilexetil in order to improve its solubility, dissolution and stability

This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and drugs with a narrow therapeutic index present high risks from dose dumping, despite being formulated in a manner

Nanoemulsion is considered to be a new and exciting field of research that seeks to exploit the attractive properties of components to improve oral delivery of drugs like candesartan cilexetil used in the management of chronic diseases. Candesartan cilexetil is a lipophilic acidic drug with a half-life of about (5–10) hour and absolute bioavailability of (14–40%). For this reason, the study target

Theoretically, calculating the sample size required for achieving the desired power is straightforward with true coefficient of variance (CV) estimates and true test/reference geometric mean ratios (GMRs) of selected parameters. However, true variance estimates are often not known and are, instead, based on published literature or pilot trials. An open-label, two-stage, adaptive, sequential two-period

The non-isothermal method for prediction of chemical stability of pharmaceuticals has been discussed in the literature for almost half a century but it has not yet been systematically evaluated. The purpose of this study was to carry out a comprehensive experimental evaluation of the non-isothermal method against the conventional isothermal method for a fast preformulation stability screening. The

An AAPS joint face-to-face meeting was held on April 6th, 2016 at MedImmune, Gaithersburg, MD. The meeting was organized by members of the Steering Committees of the Stability Focus Group, the Pharmaceutical Impurities Focus Group and the Chemistry, Manufacturing and Controls (CMC) Statistics Focus Group. Twenty two subject-matter-experts (SME) from the Industry and the Food & Drug Administration (FDA)

The gap in the commercially-available pediatric drug products and formulations suitable for children, especially those below the age of 6 years, is long recognized. A group of clinicians and scientists with a common interest in pediatric drug development and medicines-use systems developed a practical framework for identifying a list of active pharmaceutical ingredients (APIs) with the greatest market

The computer program ASAPprime® has been used successfully for some time to predict the stability of active pharmaceutical ingredients (APIs) in solid-dosage forms. In this study, we have demonstrated that the ASAPprime® program can also be used to predict the slow-down in dissolution of two APIs in an immediate release tablet. The tablets were pre-equilibrated at 25 °C at different relative humidities

The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available

The statement made by Debra Schotik Chan in 2001 (Chan 2001) regarding the regulations for use of bulk drugs in animals being unclear was probably true until last year. In May 2015 FDA issued a draft guidance on compounding animal drugs from bulk drug substances (Guidance for Industry (Draft) (#230) 2015). The guidance included specific FDA mandated conditions for animal drug compounding for each of:

The original version of this article (Hastedt et al. 2016) contained an error. The twelfth author’s name was inadvertently misspelled. The correct spelling is Masahiro Sakagami. Hastedt JE, Per B, Clark AR, William D, Anthony H, Guenther H, Kuehl PJ, Claus-Michael L, Peter M, Jason MC, Ralph N, Masahiro S, Weers JG (2016) Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP

Excipients represent diverse classes of molecules, small molecules or macromolecules, with versatile structures within a given class and are from natural, semi-synthetic and synthetic sources. They are essential ingredients in drug products independently of the route of administration where both traditional and non-traditional uses are present. Beyond their traditional use as formulation and manufacturing

The relevance of solid form in drug development has been well established over time. In order to fully understand drug properties, attention has been paid to solid state structure of drug molecules and their relationship to the drug formulation. While each drug developer has had their own strategies and workflows for screening and choosing solid forms of drug molecules, the industry is aware of instances

The Biopharmaceutics Classification System (BCS), developed in the 1990s for oral immediate release drugs, is utilized by R&D scientists and regulators to streamline product development and regulatory approval timelines. This elegant, science-based approach is based on three in vitro parameters representing a combination of drug substance physicochemical and physiological properties with respect to