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Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report. 2011

Dennis O'Connor, and Wallace P Adams, and Mei-Ling Chen, and Peter Daley-Yates, and John Davis, and Hartmut Derendorf, and Murray P Ducharme, and Anders Fuglsang, and Myra Herrle, and Günther Hochhaus, and Susan M Holmes, and Sau L Lee, and Bing V Li, and Svetlana Lyapustina, and Stephen Newman, and Martin Oliver, and Beverley Patterson, and Joanne Peart, and Guirag Poochikian, and Partha Roy, and Tushar Shah, and Gur Jai Pal Singh, and Sandra Suarez Sharp
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 06877-0368, USA. dennis.oconnor@boehringer-ingelheim.com

In April 2010 a workshop on the "Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products" was sponsored by the Product Quality Research Institute (PQRI) in coordination with Respiratory Drug Delivery (RDD) 2010. The objective of the workshop was to evaluate the current state of knowledge and identify gaps in information relating to the potential use of pharmacokinetics (PK) as the key indicator of in vivo bioequivalence (BE) of locally acting orally inhaled products (OIPs). In addition, the strengths and limitations of the PK approach to detect differences in product performance compared with in vitro and pharmacodynamic (PD)/clinical/therapeutic equivalence (TE) studies were discussed. The workshop discussed the relationship between PK and lung deposition, in vitro assessment, and PD studies and examined potential PK study designs that could serve as pivotal BE studies. It has been recognized that the sensitivity to detect differences in product performance generally decreases as one moves from in vitro testing to PD measurements. The greatest challenge in the use of PD measurements with some OIPs (particularly inhaled corticosteroids) is the demonstration of a dose-response relationship (for local effects), without which the bioassay, and hence a PD study, may not have sufficient sensitivity to detect differences in product performance. European authorities allow demonstration of in vivo BE of OIPs based solely on pharmacokinetic studies. This workshop demonstrated broader interest among discipline experts and regulators to explore approaches for the use of PK data as the key determinant of in vivo equivalence of locally acting OIPs. If accepted, the suggested approach (PK alone or in conjunction with in vitro tests) could potentially be applied to demonstrate BE of certain orally inhaled drugs.

UI MeSH Term Description Entries
D004335 Drug and Narcotic Control Control of drug and narcotic use by international agreement, or by institutional systems for handling prescribed drugs. This includes regulations concerned with the manufacturing, dispensing, approval (DRUG APPROVAL), and marketing of drugs. Drug Regulations,Narcotic Control,Pharmaceutical Policy,Drug Control,Narcotic and Drug Control,Pharmaceutic Policy,Control, Drug,Control, Narcotic,Controls, Drug,Controls, Narcotic,Drug Controls,Drug Regulation,Narcotic Controls,Pharmaceutical Policies,Policies, Pharmaceutical,Policy, Pharmaceutical,Regulation, Drug,Regulations, Drug
D004338 Drug Combinations Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture. Drug Combination,Combination, Drug,Combinations, Drug
D004983 Ethanolamines AMINO ALCOHOLS containing the ETHANOLAMINE; (-NH2CH2CHOH) group and its derivatives. Aminoethanols
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068297 Fluticasone-Salmeterol Drug Combination A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE. Advair,Advair Diskus,Advair HFA,Fluticasone - Salmeterol,Fluticasone Propionate - Salmeterol,Fluticasone Propionate - Salmeterol Combination,Fluticasone Propionate - Salmeterol Xinafoate,Fluticasone Propionate, Salmeterol Xinafoate Drug Combination,Fluticasone Propionate-Salmeterol Drug Combination,Fluticasone Propionate-Salmeterol Xinafoate Combination,Fluticasone Propionate-Salmeterol Xinafoate Drug Combination,Fluticasone-Salmeterol Combination,Seretide,Combination, Fluticasone-Salmeterol,Drug Combination, Fluticasone-Salmeterol,Fluticasone Propionate Salmeterol,Fluticasone Propionate Salmeterol Combination,Fluticasone Propionate Salmeterol Drug Combination,Fluticasone Propionate Salmeterol Xinafoate,Fluticasone Propionate Salmeterol Xinafoate Combination,Fluticasone Propionate Salmeterol Xinafoate Drug Combination,Fluticasone Salmeterol,Fluticasone Salmeterol Combination,Fluticasone Salmeterol Drug Combination
D000068759 Formoterol Fumarate An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. 3-Formylamino-4-hydroxy-alpha-(N-1-methyl-2-p-methoxyphenethylaminomethyl)benzyl alcohol.hemifumarate,Arformoterol,BD 40A,Eformoterol,Foradil,Formoterol,Formoterol Fumarate, ((R*,R*)-(+-))-isomer,Formoterol, ((R*,R*)-(+-))-isomer,Oxis
D000280 Administration, Inhalation The administration of drugs by the respiratory route. It includes insufflation into the respiratory tract. Drug Administration, Inhalation,Drug Administration, Respiratory,Drug Aerosol Therapy,Inhalation Drug Administration,Inhalation of Drugs,Respiratory Drug Administration,Aerosol Drug Therapy,Aerosol Therapy, Drug,Drug Therapy, Aerosol,Inhalation Administration,Administration, Inhalation Drug,Administration, Respiratory Drug,Therapy, Aerosol Drug,Therapy, Drug Aerosol
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000420 Albuterol A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol. Salbutamol,2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol,Albuterol Sulfate,Proventil,Sultanol,Ventolin
D000730 Androstadienes Derivatives of the steroid androstane having two double bonds at any site in any of the rings.

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