Shah V.P.,Pharmaceutical Consultant |
Bansal S.,Hoffmann-La Roche
Bioanalysis | Year: 2011
Bioanalytical methods employed for the quantitative determination of drugs and their metabolites in biological fluids provide essential regulatory data for bioavailability, bioequivalence, pharmacokinetic and toxicokinetic studies. The quality of these studies is directly related to the underlying bioanalytical data. Data generated by a typical bioanalytical laboratory is submitted to not only the local regulatory agency, but also to multiple regulatory agencies worldwide. Many pharmaceutical companies and CROs are now performing bioanalytical work for global submissions and the regulatory agencies are often reviewing the bioanalytical work performed in other countries. The bioanalytical workplace has become global and therefore needs universal rules for quality and compliance of bioanalysis. This paper provides a historical perspective and insight into the development and evolution of the regulatory guidance for bioanalytical method validation and analysis of samples. © 2011 Future Science Ltd.
PubMed | Lonza AG, University Utrecht, Pharmaceutical Consultant, China Pharma and 9 more.
Type: Journal Article | Journal: Journal of pharmaceutical sciences | Year: 2016
The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years. Areas covered are drug design and discovery, natural products, formulation design and pharmaceutical technology, pharmacokinetics/pharmacodynamics and systems pharmacology, translational and personalized medicine, biotechnology, analytical sciences and quality control, and regulatory science.
News Article | November 15, 2016
Led by well-known Pharmaceutical Consultant Andrew Campbell, ComplianceOnline’s popular seminar on quality oversight of CMOs comes to Florida in 2017. This training program will address regulatory requirements for CMO quality oversight and will help attendees understand the CMO business model. Given the constant updates in the industry, each session in the seminar will cover these industry updates and focus on best practices on how to manage CMOs on an ongoing basis. The training will focus on the topics such as selection and qualification of CMOs, development of quality agreements, understand CMO operations, and review of key CMO records and others. Seminar instructor Andrew Campbell has over 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management. For more information or to register for the seminar, please click here. Dates: Thursday, March 30, 2017 (8.00 AM- 4.30 PM) and Friday, March 31, 2017 (9.00 AM- 1.00 PM) Location: Tampa, FL Registration Cost: $1,899.00 per registration Early bird discounts: For discounts on early registrations, please click here. Register by phone: Please call our customer service specialists at +1-888-717-2436 or email to customercare(at)complianceonline(dot)com For more information on ComplianceOnline or to browse through our trainings, please visit our website. ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations. For more information please contact:
Nguyen T.A.,University of South Australia |
Nguyen T.A.,Hanoi University of Pharmacy |
Knight R.,University of New South Wales |
Roughead E.E.,University of South Australia |
And 2 more authors.
Health Policy and Planning | Year: 2015
Pharmaceutical expenditure is rising globally. Most high-income countries have exercised pricing or purchasing strategies to address this pressure. Low- and middle-income countries (LMICs), however, usually have less regulated pharmaceutical markets and often lack feasible pricing or purchasing strategies, notwithstanding their wish to effectively manage medicine budgets. In highincome countries, most medicines payments are made by the state or health insurance institutions. In LMICs, most pharmaceutical expenditure is out-ofpocket which creates a different dynamic for policy enforcement. The paucity of rigorous studies on the effectiveness of pharmaceutical pricing and purchasing strategies makes it especially difficult for policy makers in LMICs to decide on a course of action. This article reviews published articles on pharmaceutical pricing and purchasing policies. Many policy options for medicine pricing and purchasing have been found to work but they also have attendant risks. No one option is decisively preferred; rather a mix of options may be required based on country-specific context. Empirical studies in LMICs are lacking. However, risks from any one policy option can reasonably be argued to be greater in LMICs which often lack strong legal systems, purchasing and state institutions to underpin the healthcare system. Key factors are identified to assist LMICs improve their medicine pricing and purchasing systems. © The Author 2014; all rights reserved.
Wawruch M.,Comenius University |
Kuzelova M.,Comenius University |
Foltanova T.,Comenius University |
Ondriasova E.,Comenius University |
And 4 more authors.
International Journal of Clinical Pharmacy | Year: 2013
Background There is a lack of studies evaluating the factors which influence the perception of safety of over-the-counter (OTC) medications by elderly patients. Objective The aim of our questionnaire survey was to evaluate the perception of the risk of OTC medications by elderly patients and to identify patient-associated characteristics which determine elderly persons who consider OTC medications as safe. Setting 25 community pharmacies in different regions of the Slovak Republic. Methods A 54-items questionnaire was provided to patients aged ≥65 years who were purchasing at least one OTC medication during the period from May 2010 to November 2010. The questions elicited information on (a) self-assessment of health status; (b) basic characteristics of OTC medications use (e.g. frequency, duration); (c) patients' knowledge on OTC medications; (d) participants' perception of the risk of OTC medications; (e) the list of OTC and prescription-only medications taken; and (f) sociodemographic characteristics of respondents. Results Of the 793 questionnaires distributed, 519 were finally included in the statistical analysis (response rate of 65.4 %). Women were prevailing in the analysed group (n = 361; 69.6 %). The average age of participants was 72.2 ± 5.6 years. Majority (n = 392, 75.5 %) of the respondents considered OTC medications as safe. Multivariate analysis (binary logistic regression) revealed that elderly patients who considered OTC medications as safe were characterised by use of OTC medications every day (OR = 2.09), preferring a wide range of such drugs in pharmacies (OR = 2.86), considering such medications as effective (OR = 10.33), obtaining information on OTC drugs from pharmacists (OR = 1.91) and willingness to possibly purchase OTC medications outside pharmacies (OR = 3.35). On the other hand, allergic conditions as a reason for purchasing OTC medications (OR = 0.23), recommendation of a physician regarding the choice of OTC medications (OR = 0.51) and considering concurrent use of several medications as a factor increasing the risk of adverse drug reactions (OR = 0.62) emerged as important factors that decreased the probability of elderly patients considering OTC medications as safe. Conclusions The survey identified various factors that influenced the perceptions of the safety of OTC medications by the elderly and indicated that pharmacists represent the most trusted source of information about OTC medications. © 2012 Springer Science+Business Media Dordrecht.
PubMed | DOLE Pharma LLC, Pharmaceutical Consultant, Carol Davila University of Medicine and Pharmacy and University College London
Type: Journal Article | Journal: International journal of pharmaceutics | Year: 2015
The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in drug industry and regulatory approval has shown significant progress. This has been the case primarily because BCS was developed using sound scientific judgment. Following the success of BCS, we have considered the topical drug products for similar classification system based on sound scientific principles. In USA, most of the generic topical drug products have qualitatively (Q1) and quantitatively (Q2) same excipients as the reference listed drug (RLD). The applications of in vitro release (IVR) and in vitro characterization are considered for a range of dosage forms (suspensions, creams, ointments and gels) of differing strengths. We advance a Topical Drug Classification System (TCS) based on a consideration of Q1, Q2 as well as the arrangement of matter and microstructure of topical formulations (Q3). Four distinct classes are presented for the various scenarios that may arise and depending on whether biowaiver can be granted or not.
Crommelin D.J.A.,University Utrecht |
De Vlieger J.S.B.,A.P.Pharma |
Weinstein V.,Teva Pharmaceutical Industries |
Muhlebach S.,A.P.Pharma |
And 2 more authors.
AAPS Journal | Year: 2014
In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) and offers a proposal for a globally accepted terminology regarding (non-) biological complex drugs. © 2013 American Association of Pharmaceutical Scientists.
PubMed | DOLE Pharma LLC, Pharmaceutical Consultant and Carol Davila University of Medicine and Pharmacy
Type: Journal Article | Journal: International journal of pharmaceutics | Year: 2016
Both biopharmaceutics classification system (BCS) and topical drug classification system (TCS) are based on sound scientific principles with the aim of providing biowaiver and reducing regulatory burden without lowering the quality requirements and standards of approval for the drug products. BCS is based on the solubility and permeability properties of the active pharmaceutical ingredient (API, or drug substance) whereas the TCS is based on the qualitative and quantitative composition of the dosage form and the in vitro release rate of the active ingredient as key decision tools. Both BCS and TCS take drug release and dissolution as their guiding principle for providing biowaiver, increasing the availability and affordability of safe and effective medicines to the consumers and at the same time maintaining the drug product quality.
Shah R.R.,Pharmaceutical Consultant
Drug Safety | Year: 2016
Since the approval of the first molecularly targeted tyrosine kinase inhibitor (TKI), imatinib, in 2001, TKIs have heralded a new era in the treatment of many cancers. Among their innumerable adverse effects, interstitial lung disease (ILD) is one of the most serious, presenting most frequently with dyspnea, cough, fever, and hypoxemia, and often treated with steroids. Of the 28 currently approved TKIs, 16 (57 %) are reported to induce ILD with varying frequency and/or severity. The interval from drug administration to onset of ILD varies between patients and between TKIs, with no predictable time course. Its incidence is variously reported to be approximately 1.6–4.3 % in Japanese populations and 0.3–1.0 % in non-Japanese populations. The mortality rate is in the range of 20–50 %. Available evidence (primarily following the use of erlotinib and gefitinib in Japan because of the unique susceptibility of that population) has identified a number of susceptibility and prognostic risk factors (male sex, a history of smoking, and pre-existing pulmonary fibrosis being the main ones). Although the precise mechanism is not understood, collective evidence suggests that immune factors may be involved. If TKI-induced ILD is confirmed by thorough evaluation of the patient and exclusion of other causes, management is supportive, and includes discontinuation of the culprit TKI and administration of steroids. Discontinuing the culprit TKI presents a clinical dilemma because the diagnosis of TKI-induced ILD in a patient with pre-existing pulmonary fibrosis can be challenging, the patient may have TKI-responsive cancer with no suitable alternative, and switching to an alternative agent, even if available, carries the risk of the patient experiencing other toxic effects. Preliminary evidence suggests that therapy with the culprit TKI may be continued under steroid cover and/or at a reduced dose. However, this approach requires careful individualized risk–benefit analysis and further clinical experience. © 2016 Springer International Publishing Switzerland
GL Amidon, H Lennernas, VP Shah, and JR Crison A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 12, 413-420, 1995--backstory of BCS
PubMed | Pharmaceutical Consultant
Type: Historical Article | Journal: The AAPS journal | Year: 2014
The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.