References/Translations

BIOANALYTICAL GUIDANCE DOCUMENTS

Brazil - ANVISA

RDC 27/2012, May 2012 (Complete English Translation) Terms of Use

Translators: Juliane Carvalho and Donald L Reynolds, PhD

RESOLUÇÃO – RDC Nº 27, DE 17 DE MAIO DE 2012 (Original ANVISA Source Document)

ANVISA’s Bioanalytical Guidance RDC 27/2012

PowerPoint presentation by João Tavares Neto, Head of Bioequivalence Department, Brazilian Health Surveillance Agency, European Bioanalytical Forum, Barcelona, Spain, November 2012

Canada - TPD

Guideline on Bioanalytical Method Validation, July 2011

Canada has adopted the EMA Guidance Document

China - SFDA

生物样品定量分析方法指导原则（草案）Guidance on Bioanalysis: Method Validation and Analysis of Study Samples (Draft), 2011 (Chinese)

EU – EMA

Guideline on Bioanalytical Method Validation, July 2011

Japan – MHLW

Draft Guideline on Bioanalytical Method Validation in Pharmaceutical Development, 15 April 2013

United States – FDA

Draft Guidance for Industry - Bioanalytical Method Validation, September 2013

Guidance for Industry - Bioanalytical Method Validation, May 2001

GOOD LABORATORY PRACTICES (GLP)

FDA CFR 21 Part 58

Good Laboratory Practice for Nonclinical Laboratory Studies

OECD

OECD Series on Principals of Good Laboratory Practice and Compliance Monitoring

LINKS

Brazil Pharma News
Juliane Carvalho

Drug Metabolism, Pharmacokinetics and Toxicokinetics

R&D Services, LLC
Thomas N. Thompson, PhD

Preformulation, Pharmaceutical and Analytical Development and CMC

Riley and Rabel Consulting Services, LLC
Chris Riley, PhD and Shelley Rabel, PhD

ANVISA DOCUMENTS AND ENGLISH TRANSLATIONS

The original regulatory documents are published by the Ministry of Health Brazilian National Health Surveillance Agency (ANVISA) in Brazilian Portuguese. English translations have been prepared by Juliane Carvalho (www.BrazilPharmaNews.com) and Donald L. Reynolds, PhD & Associates, Inc. (www.dlrconsulting.net) using sources believed to be reliable and a knowledge of the original language. Translations have not been reviewed or approved by ANVISA or regulators/offices in Brazil. The translations do not take the place of the official regulations which may be given a different meaning by the regulators/officials in Brazil or advice from professionals familiar with the industry and customs in Brazil. The authors make no representations or warranties that the information on this Website and the translations provided herein are true and accurate for use in Brazil.

Translation documents may not be copied, reproduced, republished, uploaded, posted, transmitted, commercialized or distributed in any way or form without written consent. If granted in writing (including email), reproduction will be limited to one copy for personal use and excludes any right to reproduction, transfer or other republication in any form. The complete Terms of Use document can be viewed here.

RDC 45/2012 – Stability

Posted by Donald Reynolds on Sep 9, 2014 in Bioanalytical Translations, Uncategorized | 0 comments

RDC 45/2012 – Stability Provides guidance for conducting stability studies of active pharmaceutical ingredients. RDC 45/2012, August 2012 (Complete English Translation) Terms of Use Translators: Juliane Carvalho and Donald L Reynolds, PhD RESOLUÇÃO – RDC Nº 45, DE 10 DE AGOSTO DE 2012 (Original ANVISA Source...

RDC 21/2013 – Procedures for Granting Patents for Pharmaceutical Products and Processes

Posted by Donald Reynolds on May 30, 2013 in Bioanalytical Translations | 0 comments

RDC 21/2013 – Procedures for Granting Patents for Pharmaceutical Products and Processes Changes Resolution – RDC # 45 of 23 June 2008, which establishes the administrative procedure concerning the prior approval of ANVISA for the grant of patents for pharmaceutical products and processes. RDC 21/2013 (Complete English Translation) Terms of Use Translators: Juliane Carvalho and Donald L Reynolds, PhD RESOLUÇÃO -RDC Nº 21, DE 10 DE ABRIL DE 2013 (Original ANVISA Source...

RDC 20/2013 – Electronic Registration Procedures

Posted by Donald Reynolds on May 30, 2013 in Bioanalytical Translations | 0 comments

RDC 20/2013 – Electronic Registration Procedures Regulates the procedures for the electronic registration of new medications. RDC 20/2013 (Complete English Translation) Terms of Use Translators: Juliane Carvalho and Donald L Reynolds, PhD RESOLUÇÃO – RDC Nº 20, DE 10 DE ABRIL DE 2013 (Original ANVISA Source...

RDC 27/2012 – Bioanalytical Method Validation

Posted by Donald Reynolds on May 30, 2013 in Bioanalytical Translations | 0 comments

RDC 27/2012 – Bioanalytical Method Validation Provides the minimum requirements for the validation of bioanalytical methods used in studies for the registration and post-registration of medicines. RDC 27/2012, May 2012 (Complete English Translation) Terms of Use Translators: Juliane Carvalho and Donald L Reynolds, PhD RESOLUÇÃO – RDC Nº 27, DE 17 DE MAIO DE 2012 (Original ANVISA Source...

Testimonials

“Our company was having issues with ISR and sample reproducibility with a particular bioanalytical method validation. We hired Don to work with our CRO to troubleshoot and solve the problem. He methodically eliminated issues and ultimately resolved the root cause of the problem. With Don’s insight and guidance, the CRO successfully completed the bioanalytical method validation and client sample analysis.”

Sharon Perry
Associate Director, Quality,
ARCA Biopharma, Inc.

“I have known and worked with Don for nearly 25 years, in the environments of a big Pharma company, a CRO and as now as an independent consultant. I highly recommend Don because he brings a unique blend of scientific expertise in bioanalytical chemistry, a meticulous work ethic and a high sense of integrity to every job he undertakes.”

Thomas N. Thompson, PhD
President and Principal Consultant
R&D Services Pharma Consulting

“Dr. Donald Reynolds was associated with Lotus Clinical Research Academy to share his knowledge & experience with students and Faculty members. Don is a thorough professional with excellent subject matter knowledge. He is also a meticulous teacher. His classes on various aspects of bioanalytical techniques were enjoyed thoroughly by everyone. His experience in the field of Bioanalytical Techniques is simply marvelous.”

Dr. Arindam Mukhopadhyay
Dean, Lotus Clinical Research Academy Pvt. Ltd.,
Bangalore, India

“As a small company, we needed to ascertain the quality of vendors prior to placing work at their facility because we simply could not afford any mistakes. We hired Don Reynolds Consulting to audit a bioanalytical facility for project that was just re-prioritized and placed on the fast track for development. Don provided us a high quality and thorough assessment of our potential bioanalytical laboratory and provided a clean and concise audit report such that the team felt comfortable with placing the work at the facility. Because we were short staffed and did not have the experience to assess this type of laboratory within our group, it was comforting to know that Don with his years of experience could do this assessment for us, enabling us to make the final decision in a timely manner”

Anonymous
Director Project Coordination
(small biotech in the Boston area)

“Don has been a mentor and friend of mine for over 10 years. We initially worked closely together for a multinational CRO supporting preclinical and clinical bioanalytical programs for the pharma and biotech industry. Now that my colleagues and I operate our own preclinical CRO, I call on Don as an independent bioanalytical consultant, as my “go to” expert when our clients run into bioanalytical issues – with Don advising on methods development and validation, and sample analysis, and performing technical and quality audits for our clients and us.”

Matthew Frick
Director, Business Development,
Xenometrics, LLC

“I have worked with Don Reynolds previously as a colleague and now he consults with my company on bioanalytical projects. Don is a thorough professional with excellent subject matter knowledge. He is detail oriented and provides valuable guidance in managing bioanalytical labs, conducting vendor qualification visits, lab audits, data review, and method development. His experience in this area makes him an asset to any group working with him. I have no hesitation in recommending Don as a bioanalytical consultant.”

Annonymous
Head of Clinical Pharmacology/DMPK,
(Pharma Company in Northeastern US)

BIOANALYTICAL GUIDANCE DOCUMENTS

GOOD LABORATORY PRACTICES (GLP)

LINKS

ANVISA DOCUMENTS AND ENGLISH TRANSLATIONS

RDC 45/2012 – Stability

RDC 21/2013 – Procedures for Granting Patents for Pharmaceutical Products and Processes

RDC 20/2013 – Electronic Registration Procedures

RDC 27/2012 – Bioanalytical Method Validation

Testimonials

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